sssohrab/ct-dosing-errors-benchmark · Datasets at Hugging Face

[ 3 ]

70

RANDOMIZED

SEQUENTIAL

0TREATMENT

4QUADRUPLE

false

0ALL

true

This Phase II study is designed to determine whether a single 600 mg dose or 400mg/day for 3 days of tafenoquine is efficacious, and well tolerated for clearing P. vivax malaria infection (blood schizontocidal and gametocytocidal activity) and preventing P. vivax relapse (hypnozoite eradication). It will also further establish the safety and tolerability of these doses of tafenoquine.

This was a randomized, active-control, double-blind, double-dummy study to be conducted in 2 sequential cohorts. Cohort 1 was randomized 2:1 to receive tafenoquine, 400mg/day for 3 days, or the standard blood schizontocidal dosing regimen of chloroquine (1000mg for 2 days followed by 500mg for 1 day) followed by a standard hypnozoite eradication dosing regimen for primaquine (15mg base per day for 14 days). Cohort 2 was to be randomized 2:1 to receive a single 600mg dose of tafenoquine or the standard blood schizontocidal dosing regimen of chloroquine (1000mg for 2 days followed by 500mg for 1 day) followed by a standard hypnozoite eradication dosing regimen for primaquine (15mg base per day for 14 days). A planned interim analysis was performed after all subjects in Cohort 1 had completed the day 28 assessment and an Independent Data Monitoring Committee (IDMC) convened to evaluate the efficacy and safety of the tafenoquine dosing regimen (400mg once per day for 3 days) used in Cohort 1. Only if the results from Cohort 1 met pre-defined efficacy and safety criteria was enrollment to begin for Cohort 2. The efficacy criterion for achieving the primary endpoint was that the lower limit of the one-sided 95% confidence interval was no less than 85%, and for safety that a review of trends in all AEs, tolerability, medical observations, methemoglobin and other lab data for all subjects indicated the dose was well tolerated. During the IDMC review it was determined that Cohort 1 failed to meet the pre-specified endpoint for the day 28 cure rate and therefore Cohort 2 should not be initiated and follow-up in Cohort 1 should be completed according to protocol. Following last subject last visit for Cohort 1 the study was terminated.

Malaria Plasmodium Vivax

malaria Plasmodium vivax adults treatment tafenoquine

null

4

arm 1: Tafenoquine: 2 capsules (200mg base/capsule for a total of 400mg base) and 4 chloroquine placebo capsules for 2 days, followed by 2 tafenoquine capsules and 2 chloroquine placebo capsules for 1 day, followed by 1 primaquine placebo capsule/day for 14 days. arm 2: Chloroquine (1000 mg chloroquine phosphate) and tafenoquine placebo x 2 day, followed by chloroquine (500 mg chloroquine phosphate) and tafenoquine placebo x 1day, followed by primaquine, 15 mg/day for 14 days. arm 3: Tafenoquine (600 mg base) and chloroquine placebo x 1d, chloroquine placebo x 2 days, followed by primaquine placebo for 14 days. arm 4: Chloroquine (1000 mg chloroquine phosphate) and tafenoquine placebo x 1 day, followed by chloroquine (1000 mg chloroquine phosphate) x 1 day, followed by chloroquine (500 mg chloroquine phosphate) x 1day, followed by primaquine, 15 mg/day for 14 days.

[ 0, 1, 0, 1 ]

4

[ 0, 0, 0, 0 ]

intervention 1: Tafenoquine: 2 capsules (200mg base/capsule for a total of 400mg base) and 4 chloroquine placebo capsules for 2 days, followed by 2 tafenoquine capsules and 2 chloroquine placebo capsules for 1 day, followed by 1 primaquine placebo capsule/day for 14 days. intervention 2: Chloroquine (1000 mg chloroquine phosphate) and tafenoquine placebo x 2 day, followed by chloroquine (500 mg chloroquine phosphate) and tafenoquine placebo x 1day, followed by primaquine, 15 mg/day for 14 days. intervention 3: Tafenoquine (600 mg base) and chloroquine placebo x 1d, chloroquine placebo x 2 days, followed by primaquine placebo for 14 days. intervention 4: Chloroquine (1000 mg chloroquine phosphate) and tafenoquine placebo x 1 day, followed by chloroquine (1000 mg chloroquine phosphate) x 1 day, followed by chloroquine (500 mg chloroquine phosphate) x 1day, followed by primaquine, 15 mg/day for 14 days.

intervention 1: Tafenoquine intervention 2: Chloroquine + Primaquine intervention 3: tafenoquine intervention 4: Chloroquine + Primaquine

1

Bangkok | N/A | Thailand | 100.50144 | 13.75398

0

NCT01290601

[ 2, 3 ]

28

NON_RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

true

The purpose of this trial is to determine the safety of zalutumumab as a treatment for head and neck cancer.

null

Head and Neck Neoplasms

Head and neck cancer squamous cell carcinoma of the head and neck

null

6

arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None

[ 0, 0, 0, 0, 0, 0 ]

1

[ 0 ]

intervention 1: Weekly infusion

intervention 1: Zalutumumab

5

Århus C | N/A | Denmark | N/A | N/A Copenhagen Ø | N/A | Denmark | N/A | N/A Odense | N/A | Denmark | 10.38831 | 55.39594 Lund | N/A | Sweden | 13.19321 | 55.70584 Uppsala | N/A | Sweden | 17.63889 | 59.85882

0

NCT00093041

[ 4 ]

39,876

RANDOMIZED

FACTORIAL

1PREVENTION

3TRIPLE

false

1FEMALE

true

The purpose of this study is to evaluate the effects of low-dose aspirin and vitamin E in primary prevention of cardiovascular disease and cancer in apparently healthy women.

BACKGROUND: Various doses of aspirin have been shown to be effective in preventing thrombosis or vascular occlusion in several clinical conditions. Short-term studies have documented the efficacy of aspirin in preventing occlusion of saphenous vein bypass grants, preventing myocardial infarction in patients with unstable angina, preventing transient ischemic attacks and stroke in men with cerebral vascular disease, preventing occlusion of injured coronary arteries following transluminal angioplasty and aiding in reducing myocardial infarction and total mortality in patients receiving fibrinolytic therapy. Additionally, aspirin has been effective in the secondary prevention of myocardial infarction in subjects with known coronary artery disease. The results of the Physicians' Health Study, a large-scale primary prevention trial of aspirin in male physicians, have shown a decrease in myocardial infarction, a non-significant increase in cerebral vascular events, and no difference in overall mortality. However, few studies have addressed the efficacy of aspirin in vascular diseases in women, and it is possible that the risk to benefit ratio may be different in women. Specifically, there have been no large primary prevention trials in women, who are at risk of coronary heart disease, especially after menopause. DESIGN NARRATIVE: The Women's Health Study (WHS) is a randomized, double-blind, placebo-controlled trial using a 2x2 factorial design. The WHS is sponsored by both NHBLI (HL080467) and NCI (CA047988). Approximately 1.75 million female health professionals were contacted by mail to determine if they were suitable for inclusion in the study. A three-month run-in phase was performed to screen out those with poor compliance. Randomization, which began in February 1993 and ended in January 1996, was stratified on five-year age groups. A total of 39,876 participants were randomly assigned to either Vitamin E (600 IU every other day) or placebo; and to aspirin (100 mg every other day) or placebo. IN the 2x2 factorial design, women were randomly assigned to active aspirin and placebo vitamin E (n=9,968), placebo aspirin and active vitamin E (n=9,971), active aspirin and active vitamin E (n=9,966), or placebo aspirin and placebo vitamin E (n=9,971). A description of the characteristics of women in these 4 groups is provided in J Women's Health Gend Based Med 2000;9:19-27. In the main analyses, all women on active aspirin (n=19,934) were compared to women on placebo aspirin (n=19,942); and all women on active vitamin E (n=19,937) were compared to women on placebo aspirin (n=19,939). As part of the initial trial, pre-randomization blood samples from 28,345 participants were frozen and stored for genetic analysis which has been supported by non-federal sources. The primary endpoint is the reduction of the risk of all important vascular events (a combined endpoint of nonfatal myocardial infarction, nonfatal stroke, and total cardiovascular death) and a decrease in the incidence of total malignant neoplasms of epithelial cell origin. Secondary endpoints are the individual components of the combined endpoints. Compliance is measured by replies to a questionnaire sent out every year. The trial was completed in 2004 and results were published in 2005 (N Engl J Med 2005;352:1293-304; JAMA 2005;294:47-55; JAMA 2005;294:56-65). Currently, women are being followed on an observational basis.

Cardiovascular Diseases Cerebrovascular Disorders Coronary Disease Heart Diseases Myocardial Infarction Myocardial Ischemia Vascular Diseases

null

4

arm 1: Vitamin E (600 IU every other day) and aspirin (100 mg every other day) arm 2: Vitamin E (600 IU every other day) and placebo arm 3: Aspirin (100 mg every other day) and placebo arm 4: Placebo and placebo

[ 0, 0, 0, 2 ]

3

[ 0, 0, 5 ]

intervention 1: Participants will receive 100 mg of aspirin every other day. intervention 2: Participants will receive 600 IU of vitamin E every other day. intervention 3: Participants will receive placebo.

intervention 1: Aspirin intervention 2: Vitamin E intervention 3: Placebo

0

null

0

NCT00000479

[ 3 ]

13

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

RATIONALE: Current therapies for children with primitive neuroectodermal tumors that have not responded to standard therapy provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of children with primitive neuroectodermal tumors that have not responded to standard therapy. PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on children (\> 6 months of age) with primitive neuroectodermal tumors that has not responded to standard therapy.

OBJECTIVES: * To determine the efficacy of Antineoplaston therapy in children with primitive neuroectodermal tumors that has not responded to standard therapy, as measured by an objective response to therapy (complete response, partial response or stable disease). * To determine the safety and tolerance of Antineoplaston therapy in children with a brain tumor. OVERVIEW: This is a single arm, open-label study in which children with primitive neuroectodermal tumors that have not responded to standard therapy receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues for at least 12 months in the absence of disease progression or unacceptable toxicity. After 12 months, patients with a complete or partial response or with stable disease may continue treatment. To determine objective response, tumor size is measured utilizing MRI scans, which are performed every 8 weeks for the first two years, every 3 months for the third and fourth years, every 6 months for the 5th and sixth years, and annually thereafter. PROJECTED ACCRUAL: A total of 20-40 patients will be accrued to this study.

Childhood CNS Primitive Neuroectodermal Tumor

Recurrent primitive neuroectodermal tumor

null

1

arm 1: Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.

[ 0 ]

1

[ 0 ]

intervention 1: Children with a primitive neuroectodermal tumor that has not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal).

intervention 1: Antineoplaston therapy (Atengenal + Astugenal)

1

Houston | Texas | United States | -95.36327 | 29.76328

0

NCT00003460

[ 3 ]

23

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

OBJECTIVES: I. Compare the efficacy of local care alone vs local care plus arginine butyrate in terms of healing rate in patients with refractory sickle cell ulcers. II. Determine the effect of arginine butyrate therapy on tissue factors related to promotion or inhibition of wound healing in these patients. III. Determine whether the regimen used in this study is appropriate for testing in pivotal trials.

PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two treatment arms. Arm I: Patients receive arginine butyrate IV over 6-9 hours at night 5 days a week for 12 weeks, plus concurrent standard local therapy consisting of cleaning, saline irrigation, and dressing changes as prescribed by each patient's physician. Patients who experience progressive healing receive arginine butyrate 3-4 times a week. Arginine butyrate treatment may be discontinued and reinstated following a single 2 week medical complication. Arm II: Patients receive standard local therapy alone for 12 weeks. Patients randomized to arm II may cross over to receive arginine butyrate if no or less than 25% healing is observed after 12 weeks. Patients whose ulcers have closed by at least 15% per cycle may receive 2 additional 8-week cycles of arginine butyrate therapy and are followed for 2 months after healing is completed.

Skin Ulcers Sickle Cell Anemia

dermatologic disorders genetic diseases and dysmorphic syndromes hematologic disorders rare disease sickle cell anemia skin ulcers thalassemia major

null

3

arm 1: Each subject provided his/her own dressing e.g,standard local care includes cleaning, saline irrigation, dressing changes only for 8 weeks twice a week. arm 2: Arginine Butyrate IV plus Standard local care dressing for a total of 12 weeks. Low dose 500 mg/kg or, increased dose 750 mg/kg. First week AB given 5 days in a row, over 6 to 12hours. arm 3: Patients are randomly assigned (following a table of random numbers prepared by a blinded statistician) between two arms of the study. Arm I is Standard local care dressing only, and Arm II is standard local care plus Arginine Butyrate (AB), the Investigational New Drug. Ulcers observed \& traced weekly. Ulcer area calculated by computerized planimetry. After 12 weeks of therapy, if the ulcer size decreased by at least 25%, the AB may be continued for another 8 weeks (twice), or until the ulcer closes, plus an additional 2 weeks. The patients randomized to the Control Arm (standard local care) were given the option of crossing over to Arm II If, ulcers did not close after 8 weeks of standard local care.

[ 5, 0, 5 ]

2

[ 0, 10 ]

intervention 1: To determine if Arginine Butyrate accelerates healing of refractory leg ulcers over Standard Local Care alone. intervention 2: To heal leg ulcers.

intervention 1: Arginine Butyrate intervention 2: Standard local care dressing

4

0

NCT00004412

[ 3 ]

128

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

The trial will study 2 doses of Immune Globulin Intravenous (Human), 10% Caprylate/Chromatography Purified (IGIV-C) for the number of relapses that occur in a 1 year treatment period.

This trial is designed as a multi-national, randomized, double-blind, placebo-controlled prospective trial with three parallel groups. One hundred twenty (120) patients, 40 per treatment arm, with relapsing-remitting (RR) multiple sclerosis will be enrolled in this trial. Eligible patients must have a diagnosis of MS as per the McDonald Criteria. In addition, patients must have a diagnosis of relapsing-remitting course of MS defined as periods of worsening of neurological function with full recovery or with sequelae and residual deficit upon recovery; periods between disease relapses characterized by lack of disease progression. Patients must also have active disease with at least 1 defined documented relapse in the last year. During a 2 month run-in period, 2 MRIs will be performed 6 weeks apart and patients will be stratified based on the presence or absence of 1 or more Gadolinium enhancing lesions on the first MRI (Gd-enhancing lesion yes-no) and will be randomized to one of two dose regimens of IGIV-C or matching placebo. Patients will receive study drug infusions every 4 weeks for 48 weeks for a total of 12 infusions. Patients will be evaluated by MRI every 6 weeks and by clinical assessments every 3 months. A follow-up visit will occur 4 weeks after the last infusion. The treatment groups are as follows: * IGIV-C - 0.2 g/kg body weight (bw)/infusion (2 ml/kg bw) * IGIV-C - 0.4 g/kg bw/infusion (4 ml/kg bw) * placebo (0.1% albumin) - 4 ml/kg bw/infusion For blinding purposes, at each infusion, all patients will receive a total volume of 4 ml/kg bw. For patients receiving 0.2 g/kg bw of IGIV-C, the final volume of 4 ml/kg bw will be adjusted by the addition of dextrose 5%. Placebo will be supplied as Albumin 5% or Albumin 25% and diluted with either dextrose 5% or saline to a final concentration of 0.1% albumin. Dose adaptation will be performed for subsequent infusions in case the patient's body weight has changed \> 10%. The maximum amount available per infusion will be 400 ml (8 vials) calculated for a patient with a body weight of 100 kg. The suggested initial infusion rate will be 0.02 ml/kg/min for the first 15 minutes. If there is no evidence of a hypersensitivity reaction, the infusion may be given at a slowly increasing rate over the next 30 minutes up to a maximum allowable rate of 0.08 ml/kg/min. As such, the infusion for a 70 kg patient will take approximately 1hour 15 min. The overall infusion time may have a range from 1 to 2 hours.

Multiple Sclerosis, Relapsing-Remitting

null

3

arm 1: IGIV-C 0.2 g/kg bw/infusion (2 ml/kg bw) arm 2: IGIV-C 0.4 g/kg bw/infusion (4 ml/kg bw) arm 3: placebo (0.1% albumin) 4 ml/kg bw/infusion

[ 0, 0, 2 ]

2

[ 0, 0 ]

intervention 1: None intervention 2: None

intervention 1: Immune Globulin IV [Human], 10% Caprylate/Chromatography Purified intervention 2: Albumin (Human) 25%, United States Pharmacopeia (USP)

37

Phoenix | Arizona | United States | -112.07404 | 33.44838 Tucson | Arizona | United States | -110.92648 | 32.22174 New York | New York | United States | -74.00597 | 40.71427 Stony Brook | New York | United States | -73.14094 | 40.92565 Winston-Salem | North Carolina | United States | -80.24422 | 36.09986 Burlington | Vermont | United States | -73.21207 | 44.47588 Graz | N/A | Austria | 15.45 | 47.06667 Calgary | Alberta | Canada | -114.08529 | 51.05011 London | Ontario | Canada | -81.23304 | 42.98339 Ottawa | Ontario | Canada | -75.69812 | 45.41117 Montreal | Quebec | Canada | -73.58781 | 45.50884 Brno | N/A | Czechia | 16.60796 | 49.19522 Brno | N/A | Czechia | 16.60796 | 49.19522 Prague | N/A | Czechia | 14.42076 | 50.08804 Prague | N/A | Czechia | 14.42076 | 50.08804 Düsseldorf | N/A | Germany | 6.77616 | 51.22172 Erfurt | N/A | Germany | 11.03283 | 50.9787 Giessen | N/A | Germany | 8.67554 | 50.58727 Münster | N/A | Germany | 7.62571 | 51.96236 Osnabrück | N/A | Germany | 8.0498 | 52.27264 Ulm | N/A | Germany | 9.99155 | 48.39841 Würzburg | N/A | Germany | 9.95121 | 49.79391 Athens | N/A | Greece | 23.72784 | 37.98376 Budapest | N/A | Hungary | 19.04045 | 47.49835 Budapest | N/A | Hungary | 19.04045 | 47.49835 Budapest | N/A | Hungary | 19.04045 | 47.49835 Szeged | N/A | Hungary | 20.14824 | 46.253 Haifa | N/A | Israel | 34.99928 | 32.81303 Katowice-Ligota | N/A | Poland | N/A | N/A Lodz | N/A | Poland | 19.47395 | 51.77058 Lublin | N/A | Poland | 22.56667 | 51.25 Warsaw | N/A | Poland | 21.01178 | 52.22977 Bratislava | N/A | Slovakia | 17.10674 | 48.14816 Bratislava | N/A | Slovakia | 17.10674 | 48.14816 Lund | N/A | Sweden | 13.19321 | 55.70584 Stockholm | N/A | Sweden | 18.06871 | 59.32938 Nottingham | N/A | United Kingdom | -1.15047 | 52.9536

0

NCT00220779

[ 0 ]

40

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

true

0ALL

null

The purpose of this study is a prospective,double-blinded, randomized trial to compare the rate of healing following PRK after the use of two commercially available 4th generation fluoroquinolones, moxifloxacin and gatifloxacin.

null

Epithelium, Corneal

Removal of corneal epithelium followed by excimer laser treatment during prk

null

2

arm 1: Moxifloxacin eye drops; 1 drop 4 times daily for 1 week or until complete re-epithelization (usually 3-4 days) after surgery arm 2: Gatifloxacin eyedrops; 1 drop 4 times daily for 1 week or until complete re-epithelization (usually 3-4 days) after surgery

[ 0, 0 ]

2

[ 0, 0 ]

intervention 1: 1 drop 4 times daily for 1 week or until complete re-epithelization (usually 3-4 days) after surgery intervention 2: 1 drop 4 times daily for 1 week or until complete re-epithelization (usually 3-4 days) after surgery

intervention 1: Moxifloxacin intervention 2: Gatifloxacin

1

Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511

0

NCT00414011

[ 4 ]

137

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

An extension study to evaluate the long-term safety, tolerability and efficacy of GW-1000-02 treatment in multiple sclerosis.

Patients who participated in the placebo controlled phase of this study and opted to continue receiving open label GW-1000-02 entered the follow-on extension of the study and completed symptom assessments to determine whether they were continuing to receive clinical benefit from GW-1000-02.

Multiple Sclerosis Spasticity

null

1

arm 1: Active treatment

[ 0 ]

1

[ 0 ]

intervention 1: Contained THC and CBD as extract of Cannabis sativa L. Each 100 μl actuation delivered a dose containing 2.7 mg THC and 2.5mg CBD. The maximum permitted dose was eight actuations (22 mg THC and 20 mg CBD) in any three hour period, and 48 actuations (130 mg THC and 120 mg CBD) in any 24 hour period.

intervention 1: GW-1000-02

1

Oxford | N/A | United Kingdom | -1.25596 | 51.75222

0

NCT01610687

[ 3 ]

8

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

Current therapies for Cancer of Unknown Primary Origin provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of Cancer of Unknown Primary Origin. PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on patients with Cancer of Unknown Primary Origin.

Cancer of Unknown Primary Origin patients receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues up to 12 months in the absence of disease progression or unacceptable toxicity. OBJECTIVES: * To determine the efficacy of Antineoplaston therapy in patients with Cancer of Unknown Primary Origin, as measured by an objective response to therapy (complete response, partial response or stable disease). * To determine the safety and tolerance of Antineoplaston therapy in patients with Cancer of Unknown Primary Origin. * To determine objective response, tumor size is measured utilizing MRI scans, which are performed every 8 weeks for the first two years, every 3 months for the third and fourth years, every 6 months for the 5th and sixth years, and annually thereafter.

Unknown Primary Carcinoma

null

1

arm 1: Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.

[ 0 ]

1

[ 0 ]

intervention 1: Patients with Cancer of Unknown Primary Origin will receive Antineoplaston therapy (Atengenal + Astugenal). The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1.

intervention 1: Antineoplaston therapy (Atengenal + Astugenal)

1

Houston | Texas | United States | -95.36327 | 29.76328

0

NCT00003526

[ 3 ]

13

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

Current therapies for Stage IV Melanoma provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of Stage IV Melanoma. PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on patients with Stage IV Melanoma.

Stage IV Melanoma patients receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues up to 12 months in the absence of disease progression or unacceptable toxicity. OBJECTIVES: * To determine the efficacy of Antineoplaston therapy in patients with Stage IV Melanoma, as measured by an objective response to therapy (complete response, partial response or stable disease). * To determine the safety and tolerance of Antineoplaston therapy in patients with Stage IV Melanoma. * To determine objective response, tumor size is measured utilizing MRI scans, which are performed every 8 weeks for the first two years, every 3 months for the third and fourth years, every 6 months for the 5th and sixth years, and annually thereafter.

Stage IV Melanoma

Stage IV melanoma of the skin

null

1

arm 1: Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.

[ 0 ]

1

[ 0 ]

intervention 1: Patients with Stage IV Melanoma will receive Antineoplaston therapy (Atengenal + Astugenal). The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1.

intervention 1: Antineoplaston therapy (Atengenal + Astugenal)

1

Houston | Texas | United States | -95.36327 | 29.76328

0

NCT00003509

[ 4 ]

436

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

This was a Phase 3 multicenter randomized, open-label, safety study assessing the safety of repeat doses of Medisorb® naltrexone 380 mg (VIVITROL®) administered for up to 1 year to adults with alcohol and/or opioid dependence as defined by Diagnostic and Statistical Manual of Mental Health Disorders (DSM-IV) criteria. Eligible subjects were randomized in a 6:1 ratio to receive 1 of the following regimens: a single intramuscular (IM) injection of VIVITROL administered once every 4 weeks or oral naltrexone 50 mg administered daily.

Safety evaluations included physical examinations, electrocardiograms (ECGs), laboratory measures (including plasma concentrations of naltrexone and 6β-naltrexol), assessments of injection sites, and adverse events (AEs). All subjects received psychosocial support at each study visit for the duration of the study, with interim telephone contact 2 weeks after each monthly visit.

Alcoholism

Alcoholism Alcohol dependence

null

2

arm 1: None arm 2: None

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: Administered via intramuscular (IM) injection once every 4 weeks for up to 1 year. intervention 2: Tablet taken orally once daily for up to 1 year

intervention 1: Medisorb naltrexone 380 mg intervention 2: Oral naltrexone 50 mg

0

null

1

NCT01218997

[ 4 ]

612

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

null

This study evaluates the use of Targretin capsules (bexarotene) in combination with standard chemotherapy for the treatment of metastatic Non-Small Cell Lung Cancer (NSCLC) in patients who have not yet received chemotherapy for their lung cancer.

This study evaluates the use of Targretin capsules (bexarotene) in combination with Carboplatin and Paclitaxel for the treatment of metastatic non-small cell lung cancer in patients who have not yet received chemotherapy for their lung cancer. Every patient receives a platinum-containing chemotherapy every three weeks for at least four chemotherapy cycles (approximately four months). Half of the patients are randomly assigned to receive Targretin capsules once daily in addition to the chemotherapy. The other half is randomized to receive a standard platinum-containing chemotherapy without Targretin capsules.

Non-small Cell Lung Cancer

NSCLC Targretin Retinoid Bexarotene

null

2

arm 1: None arm 2: None

[ 0, 0 ]

2

[ 0, 0 ]

intervention 1: bexarotene capsules (400 mg/m\^2/day) in combination with carboplatin IV (AUC 6) every 3 weeks and paclitaxel IV (200 mg/m\^2) every 3 weeks. Subjects in this group also received an antilipid agent which was selected at the discretion of the investigator. intervention 2: carboplatin IV (AUC 6) every 3 weeks and paclitaxel IV (200 mg/m\^2) every 3 weeks.

intervention 1: bexarotene with carboplatin and paclitaxel intervention 2: carboplatin and paclitaxel

154

0

NCT00050960

[ 3 ]

53

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

true

Conjugated linoleic acid (CLA) is form of fat found in dairy foods, beef and other natural sources. When given to small animals, decreases of body fat have been noted.. Although weight loss is the best treatment for overweight and obesity, it is difficult to maintain the loss in the long term. Because of this, treatment emphasis has turned to small weight losses obtained through non-restrictive diets and prevention of weight regain. This is a study to determine if 6 months of consumption a purified form of CLA will result in greater loss of body fat than control and to determine whether CLA consumption increases total fat oxidation, which would help explain why the weight loss occurs.

Subjects were screened and then underwent baseline evaluation. The substudy evaluation measured 24-h energy expenditure and substrate utilization by using a whole-room indirect calorimeter. Dietary fat oxidation was measured by mixing \[1-13C\]oleate and D31-palmitate into a breakfast meal and then collecting breath carbon dioxide and urine to measure the end products of oxidation. Subjects were then provided either 4 g/d of 78% active CLA isomers (3.2 g/d: 39.2% cis-9,trans-11 and 38.5% trans-10,cis-12) or 4 g/d of safflower oil placebo as 1-g gel capsule supplements. The baseline evaluations were repeated 6 mo later.

Obesity

null

2

arm 1: The group randomized to Conjugated Linoleic Acid (CLA) treatment at 4 grams per day of 39% cis-9, trans-11 CLA; 39% trans-10, cis-12 CLA; and 22% safflower oil for 6 months arm 2: The group randomized to control received 4 g/d of safflower oil.

[ 1, 2 ]

1

[ 0 ]

intervention 1: 4 grams per day of 39% cis-9, trans-11 CLA; 39% trans-10, cis-12 CLA, and 22% safflower oil for 6 months

intervention 1: conjugated linoleic acid

1

Madison | Wisconsin | United States | -89.40123 | 43.07305

0

NCT00204932

[ 4 ]

168

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

null

The purpose of this study is to determine the safety, tolerability, and efficacy of AQUAVAN® Injection when used for mild-to-moderate sedation in patients undergoing minor surgical procedures.

Randomized, open label, multi-center,midazolam adaptive dose ranging study, in which several dose levels of AQUAVAN® Injection and fentanyl citrate injection will be investigated to produce a desired sedation level in patients undergoing minor surgical and/or therapeutic procedures. A desired sedative dose/dose range and dosing paradigm will be identified based on pre-set criteria using the Modified Observer's Assessment of Alertness/Sedation (OAA/S). The desired sedative dose/dose range and dosing paradigm of AQUAVAN® Injection is defined as one that consistently provides mild to moderate sedation (Modified OAA/S between 2 and 4 inclusive) in majority of patients who are pre-medicated with fentanyl citrate injection. Midazolam is the most widely used i.v. agent for minimal-to-moderate sedation. The dose range of midazolam to induce minimal to moderate sedation was based on standard clinical practice. \[new paragraph\] All patients were pre-medicated with fentanyl citrate as an analgesic. The outpatient setting has become increasingly popular for various types of medical procedures requiring sedation. In outpatient minor surgical procedures, sedation agents are used to provide mild-to-moderate sedation and are used with other medicines for pain management. Surgeons have searched for alternative treatments to use in the outpatient setting that would provide a faster recovery time with minimal post-procedure amnesia. This injection is used following pretreatment with fentanyl citrate for pain management.

Arthroscopy Bunionectomy Osteotomy Carpal Tunnel

AQUAVAN® Injection Midazolam Minor surgical procedures Sedation

null

0

null

1

[ 0 ]

intervention 1: None

intervention 1: fospropofol disodium

0

null

0

NCT00209560

[ 5 ]

40

NON_RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

This study will evaluate the effectiveness of treatment with acetylcholinesterase inhibitors in improving cognitive function and overall rehabilitation in elderly stroke survivors.

Cognitive impairment is a common result of a stroke and can be detrimental to recovery. It can negatively affect both mental and physical functioning, thereby complicating the rehabilitation process. Although much research has targeted the effects of long-term cognitive impairment after a stroke, very little research has been done to examine the incidence and course of cognitive impairment during the first three months following a stroke. These first three months are the most important in terms of regaining function. Acetylcholinesterase inhibitors have been beneficial to both sufferers of vascular dementia and Alzheimer's disease. They may also be a useful pharmacologic intervention to enhance post-stroke rehabilitation. This study will compare the effectiveness of two acetylcholinesterase inhibitors, galantamine and donepezil, in improving cognitive function and overall rehabilitation in elderly stroke survivors. Participants in this open label study will be randomly assigned to receive either galantamine or donepezil for 12 weeks. Participants assigned to receive galantamine will receive 4 mg twice a day for 4 weeks, 8 mg twice a day for the next 4 weeks, and 12 mg twice a day for the remainder of the study. Participants assigned to receive donepezil will receive 5 mg twice a day for 6 weeks, and then 10 mg twice a day for the next 6 weeks. Functional independence will be measured at baseline and Weeks 2 and 12. In addition, a pre-stroke level of functional independence will be obtained through a structured interview with participants and their families. Participants will also be monitored for signs of depression and medication side effects throughout the study.

Cerebrovascular Accident

Cholinesterase Inhibitors Elderly Stroke Cognition

null

2

arm 1: Galantamine for 12 weeks arm 2: Donepezil for 12 weeks

[ 0, 0 ]

2

[ 0, 0 ]

intervention 1: Participants assigned to receive galantamine will receive 4 mg twice a day for 4 weeks, 8 mg twice a day for the next 4 weeks, and 12 mg twice a day for the remainder of the study. intervention 2: Participants assigned to receive donepezil will receive 5 mg twice a day for 6 weeks, and then 10 mg twice a day for the next 6 weeks.

intervention 1: Galantamine intervention 2: Donepezil

1

Pittsburgh | Pennsylvania | United States | -79.99589 | 40.44062

0

NCT00227994

[ 4 ]

107

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

null

The original objective of this study was to assess the safety and efficacy of the buprenorphine transdermal system (BTDS) (5, 10, and 20) in comparison to placebo transdermal system in subjects with moderate to severe osteoarthritis pain. However, this study was terminated early with only 35% of the planned sample size, therefore the primary objective is changed to focus on the safety evaluations.

Buprenorphine is a synthetic opioid analgesic with over 25 years of international clinical experience indicating it to be safe and effective in a variety of therapeutic situations for the relief of moderate to severe pain.

Osteoarthritis

osteoarthritis opioid transdermal

null

2

arm 1: Buprenorphine transdermal patches 10 or 20 mcg/h arm 2: Placebo to match buprenorphine transdermal patch 10 or 20

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: Buprenorphine transdermal patch applied for 7-day wear. intervention 2: Placebo to match buprenorphine transdermal patch 10 or 20.

intervention 1: Buprenorphine transdermal patch intervention 2: Placebo transdermal patch

48

0

NCT00315458

[ 3 ]

320

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

The purpose of this study is to evaluate the efficacy and safety of initial single and multiple subcutaneous injections of CNTO 1275 in the treatment of patients with moderate to severe plaque psoriasis.

This is a randomized (the study medication is assigned by chance), double blind (neither physician nor patient knows the treatment that the patient receives), parallel-group, multicenter study to determine the effectiveness and safety of two different doses of CNTO 1275 administered subcutaneously one time or as multiple doses as compared with placebo in patients with moderate to severe plaque-type psoriasis (the most common type of psoriasis). The dose of CNTO 1275 will be 45 or 90 mg administered subcutaneously once or as four weekly doses. Patients who inadequately respond to their treatment may receive one additional dose. Patients will be monitored for the safety throughout the study.

Psoriasis

Psoriasis CNTO 1275 Ustekinumab Stelara Interleukin-12 IL-12 Interleukin-23 IL-23

null

5

arm 1: Patients in the placebo group will receive placebo at Weeks 0, 1, 2, 3, and 16. At week 20, all patients will receive a single dose of ustekinumab 90 mg. arm 2: Patients will receive single dose ustekinumab at Week 0 and placebo at Weeks 1, 2, and 3. At Week 16, patients with Physician's Global Assessment (PGA) greater than or equal to 3 will receive ustekinumab 45 mg. At week 20, all patients will receive placebo. arm 3: Patients will receive 90 mg single dose ustekinumab at Week 0 and placebo at Weeks 1, 2, and 3. At Week 16 patients with PGA greater than or equal to 3 will receive ustekinumab 90 mg. At week 20, all patients will receive placebo. arm 4: Patients will receive 45 mg of ustekinumab at Weeks 0, 1, 2, and 3. At Week 16, patients with Physician's Global Assessment (PGA) greater than or equal to 3 will receive ustekinumab 45 mg. At week 20, all patients will receive placebo. arm 5: Patients will receive 90 mg of ustekinumab at Weeks 0, 1, 2, and 3. At Week 16 patients with Physician's Global Assessment (PGA) greater than or equal to 3 will receive ustekinumab 90 mg. At week 20, all patients will receive placebo.

[ 2, 0, 0, 0, 0 ]

2

[ 0, 0 ]

intervention 1: Patients will receive subcutaneous injections of ustekinumab (45 or 90 mg). intervention 2: Patients in the placebo group will receive placebo medication.

intervention 1: Ustekinumab intervention 2: Placebo

0

null

0

NCT00320216

[ 4 ]

188

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

true

The original objective of this study was to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (BTDS) 20 micrograms (mcg)/hour (h) in comparison to the buprenorphine transdermal system 5 mcg/h in subjects with moderate to severe osteoarthritis pain currently treated with oral opioids. The double-blind treatment intervention duration is 12 weeks during which time supplemental analgesic medication (acetaminophen or ibuprofen) will be provided to all subjects in addition to study drug. This study was terminated early due to administrative reasons with only 20% of the planned sample size; therefore, the primary objective was changed to focus on the safety evaluation.

Buprenorphine is a synthetic opioid analgesic with over 25 years of international clinical experience indicating it to be safe and effective in a variety of therapeutic situations for the relief of moderate to severe pain.

Osteoarthritis

Chronic pain osteoarthritis transdermal

null

2

arm 1: Buprenorphine transdermal patch 5 mcg/h, applied for 7-day wear arm 2: Buprenorphine transdermal patch 20 mcg/h, applied for 7-day wear

[ 1, 0 ]

2

[ 0, 0 ]

intervention 1: Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear intervention 2: Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear

intervention 1: Buprenorphine transdermal patch intervention 2: Buprenorphine transdermal patch

66

0

NCT00320801

[ 3 ]

45

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

true

0ALL

false

The purpose of this study is to assess the safety and efficacy of VEC-162 compared to matching placebo on circadian phase shift and sleep parameters.

null

Circadian Rhythm Sleep Disorders

null

0

null

1

[ 0 ]

intervention 1: None

intervention 1: VEC-162

2

0

NCT00490945

[ 2 ]

34

RANDOMIZED

CROSSOVER

7BASIC_SCIENCE

1SINGLE

true

0ALL

false

The purpose of this study is to evaluate and compare the relative bioavailability of a test formulation of zonisamide capsules to an equivalent dose of a reference formulation, Zonegran® (zonisamide) capsules, after a single oral dose administered under fasting conditions.

The purpose of this study is to evaluate and compare the relative bioavailability of a test formulation of zonisamide capsules to an equivalent dose of a reference formulation, Zonegran® (zonisamide) capsules, after a single oral dose administered under fasting conditions. Thirty-four healthy, non-smoking, non-obese male and female volunteers at least 18 years of age will be randomly assigned in a crossover fashion to receive each of two zonisamide dosing regimens in sequence with a 28 day washout period between dosing periods. On the morning of Day 1, after an overnight fast, subjects will receive either a single oral dose of the test formulation, zonisamide (1 x 100 mg capsule) or a single oral dose of the reference formulation, Zonegran® (1 x 100 mg capsule). After a 28 day washout period, on the morning of Day 29 after an overnight fast, subjects will receive the alternate regimen. Blood samples will be drawn from all participants before dosing and for 72 hours post dose at times sufficient to adequately define the pharmacokinetics of zonisamide. A further goal of this study is to evaluate the safety and tolerability of this regimen in healthy volunteers. Subjects will be monitored throughout the confinement portion of the study for adverse reactions to the study drug and/or procedures. Blood pressure and heart rate will be obtained prior to dosing and as scheduled following dose administration. All adverse events whether elicited by query, spontaneously reported or observed by clinic staff will be evaluated by the investigator and reported in the subject's case report form.

Healthy

Therapeutic Equivalency

null

2

arm 1: A single dose of zonisamide 100 mg administered after an overnight fast. arm 2: A single dose of Zonegran® 100 mg administered after an overnight fast.

[ 0, 0 ]

2

[ 0, 0 ]

intervention 1: 100 mg capsule administered after an overnight fast. intervention 2: 100 mg capsule administered after an overnight fast.

intervention 1: Zonisamide 100 mg Capsule intervention 2: Zonisamide (Zonegran®) 100 mg Capsule

0

null

0

NCT00685139

[ 2 ]

34

RANDOMIZED

CROSSOVER

7BASIC_SCIENCE

1SINGLE

true

0ALL

false

The purpose of this study is to evaluate the relative bioavailability (rate and extent of absorption) of a test formulation of zonisamide capsules compared to the reference formulation, Zonegran® (zonisamide)capsules, after a single oral dose administered under non-fasting conditions.

The purpose of this study is to evaluate the relative bioavailability (rate and extent of absorption) of a test formulation of zonisamide capsules compared to the reference formulation, Zonegran® (zonisamide)capsules, after a single oral dose administered under non-fasting conditions. Thirty-four healthy, non-smoking, non-obese male and female volunteers at least 18 years of age will be randomly assigned in a crossover fashion to receive each of two zonisamide dosing regimens in sequence with a 28 day washout period between dosing periods. On the morning of Day 1, 30 minutes after initiation of a standardized, high-fat breakfast, subjects will receive either a single oral dose of the test formulation, zonisamide (1 x 100 mg capsule) or a single oral dose of the reference formulation, Zonegran® (1 x 100 mg capsule). After a 28 day washout period, on the morning of Day 29, 30 minutes after initiation of a standardized, high-fat breakfast, subjects will receive the alternate regimen. Blood samples will be drawn from all participants before dosing and for 72 hours post dose at times sufficient to adequately define the pharmacokinetics of zonisamide. A further goal of this study is to evaluate the safety and tolerability of this regimen in healthy volunteers. Subjects will be monitored throughout the confinement portion of the study for adverse reactions to the study drug and/or procedures. Blood pressure and heart rate will be obtained prior to dosing and as scheduled following dose administration. All adverse events whether elicited by query, spontaneously reported or observed by clinic staff will be evaluated by the investigator and reported in the subject's case report form.

Healthy

Therapeutic Equivalency

null

2

arm 1: A single dose of zonisamide 100 mg administered 30 minutes after initiation of a standardized, high fat breakfast. arm 2: A single dose of Zonegran® 100 mg administered 30 minutes after initiation of a standardized, high fat breakfast.

[ 0, 0 ]

2

[ 0, 0 ]

intervention 1: 100 mg capsule administered 30 minutes after initiation of standardized, high-fat breakfast. intervention 2: 100 mg capsule administered 30 minutes after initiation of standardized, high-fat breakfast.

intervention 1: Zonisamide 100 mg Capsule intervention 2: Zonisamide (Zonegran®) 100 mg Capsule

1

Fargo | North Dakota | United States | -96.7898 | 46.87719

0

NCT00687167

[ 0 ]

276

NON_RANDOMIZED

SINGLE_GROUP

1PREVENTION

0NONE

false

0ALL

false

In a rural hospital in Tanzania the rate of surgical site infections (SSI) was 21.6%. Inappropriate choice of antibiotics and of administration time were determined as sole risk factors in this setting. After implementation of a standardized procedure with a single shot dose of Amoxicillin/Clavulanic Acid approximately 30 min. preoperatively the rate of SSI dropped by 80% in spite of procedural risk factors like poor hygiene etc.

Surgical Site Infections (SSIs) have an important socioeconomic impact prolonging the period of hospitalization and rehabilitation. Patients with SSIs are five times more likely to be readmitted and are even twice as likely to die compared to patients with similar interventions without SSI. In non-industrialized countries, the incidence of SSIs is higher and the consequences of SSI are even more severe: Many hospitals lack appropriate facilities for early diagnosis and treatment. In addition, microbiological identification of pathogens and susceptibility testing are rarely available, a prerequisite for targeted treatment of SSIs. Overcrowding and understaffing are additional risk factors for SSIs, common in these countries. A study conducted at the local surgeons' suggestion in an 82-bed department of general surgery, obstetrics and gynecology, urology and orthopedics at the St. Francis Designated District Hospital (SFDDH) in Ifakara (Southern Tanzania) showed an SSI-rate of 21.6%. The analyses of this study identified two major risk factors for SSI in clean and clean-contaminated surgical procedures: Inadequate timing of administration of routine antimicrobial prophylaxis (AMP) and inappropriate selection of antibiotics not covering the most commonly observed pathogens. Therefore, an intervention study was discussed with the local surgeon in charge to improve selection and timing of routine AMP and thereby reduce the rate of SSIs. The study design and objective were presented to all the staff during a general meeting and special duties and responsibilities discussed with the individual colleagues. Furthermore we distributed pocket flow sheets to the involved staff and hung up some laminated flow sheets in theatre.

Surgical Site Infection

Postoperative wound infection surgical site infection antimicrobial prophylaxis developing countries Sub-Saharan Africa reduction of SSI using preoperative antibiotics

null

1

arm 1: single shot dose of Amoxicillin/Clavulanic Acid approximately 30 min. preoperatively

[ 0 ]

1

[ 0 ]

intervention 1: single shot dose of Amoxicillin/Clavulanic Acid approximately 30 min. preoperatively

intervention 1: Amoxicillin/Clavulanic Acid

1

Basel | Canton of Basel-City | Switzerland | 7.57327 | 47.55839

0

NCT00801099

[ 2 ]

26

RANDOMIZED

CROSSOVER

null

0NONE

true

0ALL

null

To determine whether the test product, Labopharm Tramadol HCl Once-A-Day (OAD) 200 mg film-coated tablets, and the reference product, Labopharm Tramadol HCl OAD 200 mg uncoated tablets, are bioequivalent.

null

Healthy

Healthy volunteers

null

2

arm 1: Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Film-coated Tablet based on randomization schedule. arm 2: Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Uncoated Tablet based on randomization schedule.

[ 0, 0 ]

1

[ 0 ]

intervention 1: Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Film-coated Tablet or Tramadol HCl 200 mg Uncoated Tablets based on randomization schedule.

intervention 1: Tramadol HCl

0

null

0

NCT00834366

[ 5 ]

58

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

To investigate the clinical and bacteriological efficacy of Fucidin® cream in the treatment of impetigo in paediatric patients. To assess the validity of in vitro susceptibility-testing of S. aureus to fusidic acid as a prediction of clinical and bacteriological outcome in impetigo patients treated with Fucidin® cream. To investigate the genetic relationship between S. aureus-strains isolated from impetigo patients.

null

Impetigo

null

2

arm 1: None arm 2: None

[ 0, 2 ]

1

[ 0 ]

intervention 1: None

intervention 1: Fucidin® cream

2

Bergen | N/A | Norway | 5.32415 | 60.39299 Gothenburg | N/A | Sweden | 11.96679 | 57.70716

0

NCT00986856

[ 2 ]

24

RANDOMIZED

CROSSOVER

null

0NONE

true

0ALL

null

The object of this study was to compare the relative bioavailability (rate and extent of absorption) of Pramipexole Dihydrochloride Tablets 0.25 mg by Barr Laboratories, Inc. with that of Mirapex® Tablets 0.25 mg distributed by Boehringer Ingelheim Pharmaceuticals, Inc. following a single oral dose in healthy adults under fasting conditions.

Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA Bioequivalence Statistical Methods

Healthy

Bioequivalence Healthy Subjects

null

2

arm 1: Pramipexole Dihydrochloride 0.25 mg Tablets arm 2: Mirapex® 0.25 mg Tablets

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: 0.25 mg Tablet intervention 2: 0.25 mg Tablet

intervention 1: Pramipexole Dihydrochloride intervention 2: Pramipexole Dihydrochloride

1

Fargo | North Dakota | United States | -96.7898 | 46.87719

0

NCT01074450

[ 2 ]

24

RANDOMIZED

CROSSOVER

null

0NONE

true

0ALL

null

The object of this study was to compare the relative bioavailability (rate and extent of absorption) of Pramipexole Dihydrochloride Tablets 0.25 mg by Barr Laboratories, Inc. with that of Mirapex® Tablets 0.25 mg distributed by Boehringer Ingelheim Pharmaceuticals, Inc. following a single oral dose in healthy adults under non-fasting conditions.

Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA Bioequivalence Statistical Methods

Healthy

Bioequivalence Healthy Subjects

null

2

arm 1: Pramipexole Dihydrochloride 0.25 mg Tablets arm 2: Mirapex® 0.25 mg Tablets

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: 0.25 mg Tablet intervention 2: 0.25 mg Tablet

intervention 1: Pramipexole Dihydrochloride intervention 2: Pramipexole Dihydrochloride

1

Fargo | North Dakota | United States | -96.7898 | 46.87719

0

NCT01074463

[ 5 ]

24

RANDOMIZED

CROSSOVER

0TREATMENT

4QUADRUPLE

false

0ALL

null

The purpose of this clinical study is to evaluate the clinical effect of midodrine hydrochloride (ProAmatine®) compared to placebo in patients with orthostatic hypotension by measuring the time to onset of near syncopal symptoms and assessing several cardiovascular measurements, such as heart rate, blood pressure, and ECG, using the tilt table test.

null

Hypotension, Orthostatic

null

2

arm 1: None arm 2: None

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: one dose, 10-30mg, given orally intervention 2: Placebo

intervention 1: Midodrine hydrochloride intervention 2: Placebo

11

0

NCT00555880

[ 3 ]

51

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

The purpose of this study is to determine if the study drug pertuzumab is effective in treating patients with advanced lung cancer that has recurred following prior chemotherapy.

null

Non-small Cell Lung Cancer

Lung cancer

null

1

arm 1: Participants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Subjects received pertuzumab at a loading dose of 840 mg in Cycle 1 followed by a dose of 420 mg in Cycles 2 and beyond.

[ 0 ]

1

[ 0 ]

intervention 1: Pertuzumab was supplied as a single-use liquid formulation.

intervention 1: Pertuzumab

8

0

NCT00063154

[ 2 ]

21

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

null

The malignancies (advanced solid tumors) that have been chosen for evaluation of E7389 are those where E7389 has demonstrated significant pre-clinical anti-tumor activity, both in vitro and in vivo. The ultimate goal is to demonstrate the clinical activity of E7389 in the treatment of these, and potentially other, tumor types.

null

Cancer

Cancer, tumors

null

0

null

1

[ 0 ]

intervention 1: None

intervention 1: E7389

3

0

NCT00069277

[ 4 ]

120

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

The purpose of this study was to compare the efficacy of Photodynamic Therapy (PDT) methyl aminolevulinate (MAL) cream to cryotherapy, in treatment of participants with primary superficial basal cell carcinoma (BCC). Secondary objectives was to compare cosmetic outcome and tolerability (adverse events) in these participants, 3 months after treatment. In addition the recurrence rates in the two treatment groups will be compared up to five years after treatment.

BCC was a highly frequent skin malignancy, and accounts for approximately 75% of all non-melanoma skin cancers. It is the most common malignant tumour of any organ, mostly affecting head and neck (84%) in fair-skinned people. Several non-pharmacological treatment modalities was used for BCC, including excision surgery, Moh's surgery, radiation, curettage/electrodesiccation and cryotherapy. The treatment used depends on the type, size, depth and localisation of the BCC lesion. The use of PDT was attractive for the treatment of BCCs because of its efficiency, mild and local side effects and excellent cosmetic outcome. Previous clinical experience was promising and participants with primary BCCs were included in this prospective, randomised, comparative, multicenter study to show that Metvix is non-inferior to alternative treatment with better cosmetic outcome. The primary end-point is the number of participants in whom 75% or more of the BCC lesions have responded completely at 3 months after PDT with Metvix or 3 months after cryotherapy. Both on-site and independent, blinded response assessments analysed. The analysis based on the results of the independent review board constitutes the primary analysis. The secondary end-points was the proportion of participants in whom less than 75% of the BCC lesions respond completely, number of lesions across participants that show complete response, evaluation of cosmetic outcome and adverse events 3 months after Metvix PDT or 3 months after cryotherapy. In addition 12, 24, 36, 48 and 60 months recurrence rates was assessed.

Superficial Basal Cell Carcinoma

Methyl aminolevulinate Photodynamic therapy Primary Superficial Basal Cell Carcinoma

null

2

arm 1: Participants with basal cell carcinoma (BCC) lesions were administered to photodynamic therapy (PDT) with Metvix® cream 160 milligrams per gram (mg/g) applied for three hours, followed by illumination using non-coherent light with a fluency of 75 Joule per centimeter square (J/cm\*2) and fluency rate of 70-200 milliwatt per centimeter square (mW/cm\*2) up to 13 weeks. arm 2: Cryotherapy was performed with a hand-held liquid nitrogen spray, using a double freeze-thaw cycle. After an initial icefield formation with a 3 millimeter (mm) rim of clinically healthy tissue, the icefield was to be maintained for a minimum of 20 seconds. This procedure was repeated after a thaw of 2-3 times the freeze time up to 12 weeks.

[ 0, 1 ]

2

[ 0, 3 ]

intervention 1: None intervention 2: None

intervention 1: Metvix® cream intervention 2: Hand held liquid nitrogen spray cryotherapy

14

Graz | N/A | Austria | 15.45 | 47.06667 Leuven | N/A | Belgium | 4.70093 | 50.87959 Helsinki | N/A | Finland | 24.93545 | 60.16952 Marseille | N/A | France | 5.38107 | 43.29695 Paris | N/A | France | 2.3488 | 48.85341 Brescia | N/A | Italy | 10.21472 | 45.53558 Jönköping | N/A | Sweden | 14.15618 | 57.78145 Linköping | N/A | Sweden | 15.62157 | 58.41086 Örebro | N/A | Sweden | 15.2066 | 59.27412 Stockholm | N/A | Sweden | 18.06871 | 59.32938 Cardiff | N/A | United Kingdom | -3.18 | 51.48 Dundee | N/A | United Kingdom | -2.97489 | 56.46913 Falkirk | N/A | United Kingdom | -3.78535 | 56.0021 Glasgow | N/A | United Kingdom | -4.25763 | 55.86515

0

NCT00469417

[ 0 ]

553

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

The objectives of this study were to demonstrate comparable safety and efficacy of Ciclopirox Olamine Topical Suspension (Test Product) and Ciclopirox Topical Suspension 0.77% (Reference Product) in the treatment of subjects with tinea pedis, and to show the superiority of the active treatments over that of the vehicle.

null

Tinea Pedis

Tinea Pedis Ciclopirox Olamine

null

3

arm 1: Ciclopirox Olamine Topical Suspension arm 2: Loprox® Topical Suspension 0.77% arm 3: placebo of test product

[ 0, 1, 2 ]

3

[ 0, 0, 0 ]

intervention 1: topical suspension intervention 2: topical suspension intervention 3: topical suspension

intervention 1: Ciclopirox Olamine Topical Suspension intervention 2: Ciclopirox Topical Suspension 0.77%-Reference Product intervention 3: Ciclopirox Olamine Topical Suspension-Placebo

0

null

0

NCT00804193

[ 5 ]

41

NON_RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

This is a pilot investigational study of the appropriate therapeutic regimens to treat subjects experiencing inflammatory recurrence (rebound) of psoriatic disease upon discontinuation of efalizumab therapy and of the biological mechanisms involved in inflammatory disease recurrence and control.

null

Psoriasis

Psoriasis Discontinuation of efalizumab Managing inflammatory recurrence

null

5

arm 1: Starting dose 4.0 - 5.1 mg/kg/day until clinical improvement. Upon clinical improvement, cyclosporin dose to be tapered by 50% every two weeks. arm 2: Starting dose 25 - 50 mg/day until clinical improvement. Upon clinical improvement, retinoid dose to be reduced by 50%. Thereafter, treatment to be continued for 8 weeks and then stopped. arm 3: Starting dose 0.25 - 0.5 mg/kg/day until clinical improvement. Upon clinical improvement, corticosteroid dose to be reduced by 50%. Thereafter, corticosteroids to be weaned by 50% every 2 weeks. arm 4: Starting dose 20 - 25 mg per week until clinical improvement. Upon clinical improvement, dose to be reduced by 25%. Thereafter, methotrexate dose to be reduced by 25% every two weeks. arm 5: Corticosteroid starting dose 0.25 - 0.5 mg/kg/day until clinical improvement. Upon clinical improvement, corticosteroid dose to be reduced by 50%. Thereafter, to be weaned by 50% every 2 weeks. Methotrexate starting dose 20 - 25 mg per week until clinical improvement. Upon clinical improvement, dose to be reduced by 25%. Thereafter, to be reduced by 25% every two weeks.

[ 0, 0, 0, 0, 0 ]

5

[ 0, 0, 0, 0, 0 ]

intervention 1: Starting dose 4.0 - 5.1 mg/kg/day until clinical improvement. Upon clinical improvement, cyclosporin dose to be tapered by 50% every two weeks. intervention 2: Starting dose 25 - 50 mg/day until clinical improvement. Upon clinical improvement, retinoid dose to be reduced by 50%. Thereafter, treatment to be continued for 8 weeks and then stopped. intervention 3: Starting dose 0.25 - 0.5 mg/kg/day until clinical improvement. Upon clinical improvement, corticosteroid dose to be reduced by 50%. Thereafter, corticosteroids to be weaned by 50% every 2 weeks. intervention 4: Starting dose 20 - 25 mg per week until clinical improvement. Upon clinical improvement, dose to be reduced by 25%. Thereafter, methotrexate dose to be reduced by 25% every two weeks. intervention 5: Upon clinical improvement, corticosteroid dose to be reduced by 50%. Thereafter, to be weaned by 50% every 2 weeks. Methotrexate starting dose 20 - 25 mg per week until clinical improvement. Upon clinical improvement, dose to be reduced by 25%. Thereafter, to be reduced by 25% every two weeks.

intervention 1: Cyclosporins intervention 2: Retinoids intervention 3: Systemic corticosteroids intervention 4: Methotrexate intervention 5: Systemic corticosteroids/methotrexate

0

null

0

NCT01079988

[ 2 ]

24

RANDOMIZED

CROSSOVER

0TREATMENT

0NONE

true

0ALL

null

The objectives of this study were: * to compare the pharmacokinetic profiles of two prototype controlled-release (CR) trazodone hydrochloride (HCl) 300 mg tablets versus two reference products: Trittico® AC (2 x 150 mg CR tablets) and Desyrel® (3 x 100 mg IR (immediate-release) tablets) under fasting condition; * to assess the controlled release properties of the two prototype formulations; * to select a prototype formulation for further development; * to validate the blood sampling schedule for future pivotal pharmacokinetic studies; * to determine the appropriate sample size for pivotal studies based in the intra-subject variability.

null

Healthy

Healthy subjects

null

4

arm 1: Test product 1 and Test product 2 are two different prototype formulations of Trazodone Contramid® OAD (once a day) arm 2: Test product 1 and Test product 2 are two different prototype formulations of Trazodone Contramid® OAD (once a day) arm 3: None arm 4: None

[ 0, 0, 1, 1 ]

4

[ 0, 0, 0, 0 ]

intervention 1: The dosage of trazodone.HCl during this treatment phase was a single oral dose of 300 mg (one CR tablet) at 07:30 (after an overnight fast of at least 10 hours) on clinic days. intervention 2: The dosage of trazodone.HCl during this treatment phase was a single oral dose of 300 mg (one CR tablet) at 07:30 (after an overnight fast of at least 10 hours) on clinic days. intervention 3: The dosage of trazodone.HCl during this treatment phase was 2 oral doses of 150 mg each: one controlled-release (CR) tablet at 07:30 (after an overnight fast of at least 10 hours) and 19:30 (after a fast of at least 2 hours) on clinic days. intervention 4: The dosage of trazodone.HCl during this treatment phase was three oral doses of 100 mg each: one immediate-release (IR) tablet at 07:30 (after an overnight fast of at least 10 hours), 15:30 and 23:30 (both dosages after a fast of at least 2 hours) on clinic days.

intervention 1: Trazodone HCl intervention 2: Trazodone HCl intervention 3: Trazodone HCl intervention 4: Trazodone HCl

0

null

0

NCT01121913

[ 2 ]

28

RANDOMIZED

PARALLEL

7BASIC_SCIENCE

2DOUBLE

false

0ALL

false

This was a Phase 1 dose escalation study to evaluate the safety, tolerability and pharmacokinetics of 28-day treatment of CP-690,550 in stable renal allograft recipients. In Stage 1, ascending doses of CP-690,550 were to be administered sequentially to 3-4 cohorts of subjects. After Stage 1, one dose level was to be selected for dosing in an expanded cohort in Stage 2.

null

Kidney Transplant

CP-690,550 kidney transplant

null

4

arm 1: None arm 2: None arm 3: None arm 4: None

[ 2, 0, 0, 0 ]

4

[ 0, 0, 0, 0 ]

intervention 1: Placebo tables twice daily (BID) for 28 days intervention 2: CP-690,550 5 mg BID for 28 days intervention 3: CP-690,550 15 mg BID for 28 days intervention 4: CP-690,550 30 mg BID for 28 days

intervention 1: Placebo intervention 2: CP-690,550 5 mg BID intervention 3: CP-690,550 15 mg BID intervention 4: CP-690,550 30 mg BID

11

0

NCT01710033

[ 3 ]

79

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

1FEMALE

null

This study will evaluate the efficacy and safety of pertuzumab (rhuMAb 2C4) in participants with metastatic breast cancer which has progressed during or after standard chemotherapy and which is not amenable to curative therapy. Those who are maintaining a response to therapy or who have stable disease at the end of the formal study period will continue treatment until disease progression or unacceptable toxicity. Approximately 120 participants will be enrolled.

null

Breast Cancer

null

2

arm 1: Participants will not receive a loading dose, but will receive pertuzumab 1050 milligrams (mg) via intravenous (IV) infusion every 3 weeks until unacceptable toxicity or disease progression. arm 2: Participants will receive a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.

[ 0, 0 ]

1

[ 0 ]

intervention 1: Participants will receive one of two IV treatment regimens with pertuzumab: either 420 mg every 3 weeks, with an initial 840-mg loading dose, or 1050 mg every 3 weeks with no loading dose administered.

intervention 1: Pertuzumab

18

Camperdown | N/A | Australia | 151.17642 | -33.88965 Fitzroy | N/A | Australia | 144.97833 | -37.79839 Geelong | N/A | Australia | 144.36069 | -38.14711 Namur | N/A | Belgium | 4.86746 | 50.4669 Helsinki | N/A | Finland | 24.93545 | 60.16952 Tampere | N/A | Finland | 23.78712 | 61.49911 Hamburg | N/A | Germany | 9.99302 | 53.55073 Herne | N/A | Germany | 7.22572 | 51.5388 München | N/A | Germany | 13.31243 | 51.60698 Milan | N/A | Italy | 12.59836 | 42.78235 Parma | N/A | Italy | 10.32618 | 44.79935 Amsterdam | N/A | Netherlands | 4.88969 | 52.37403 Barcelona | N/A | Spain | 2.15899 | 41.38879 Barcelona | N/A | Spain | 2.15899 | 41.38879 Valencia | N/A | Spain | -0.37966 | 39.47391 Edinburgh | N/A | United Kingdom | -3.19648 | 55.95206 London | N/A | United Kingdom | -0.12574 | 51.50853 Manchester | N/A | United Kingdom | -2.23743 | 53.48095

0

NCT02491892

[ 3 ]

8

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

Current therapies for advanced Mesothelioma provide limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of advanced Mesothelioma. PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on patients with advanced Mesothelioma.

Advanced Mesothelioma patients receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues up to 12 months in the absence of disease progression or unacceptable toxicity. OBJECTIVES: * To determine the efficacy of Antineoplaston therapy in patients with advanced Mesothelioma, as measured by an objective response to therapy (complete response, partial response or stable disease). * To determine the safety and tolerance of Antineoplaston therapy in patients with advanced Mesothelioma. * To determine objective response, tumor size is measured utilizing physical examination and radiologic studies, performed every 8 weeks for the first two years, every 3 months for the third and fourth years, every 6 months for the 5th and sixth years, and annually thereafter.

Malignant Mesothelioma

advanced malignant mesothelioma recurrent malignant mesothelioma

null

1

arm 1: Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.

[ 0 ]

1

[ 0 ]

intervention 1: Patients with advanced mesothelioma will receive Antineoplaston therapy (Atengenal + Astugenal). The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1.hourly interEach infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1.

intervention 1: Antineoplaston therapy (Atengenal + Astugenal)

1

Houston | Texas | United States | -95.36327 | 29.76328

0

NCT00003508

[ 4 ]

1,395

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

1FEMALE

null

This study will assess the efficacy and safety of intravenous administration of Bonviva regimens in women with post-menopausal osteoporosis, compared to oral daily administration. Patients will also receive daily supplementation with vitamin D and calcium. The anticipated time of study treatment is 2+ years, and the target sample size is 500+ individuals.

null

Post Menopausal Osteoporosis

null

3

arm 1: oral placebo daily and IV ibandronate 2 mg q 2 mo arm 2: oral ibandronate 2.5 mg daily and IV placebo q 2 mo and q 3 mo arm 3: oral placebo daily and IV ibandronate 3 mg q 3 mo

[ 0, 0, 0 ]

3

[ 0, 0, 0 ]

intervention 1: 2mg iv every 2 months intervention 2: 2.5mg po daily intervention 3: 3mg iv every 3 months

intervention 1: ibandronate [Bonviva/Boniva] intervention 2: ibandronate [Bonviva/Boniva] intervention 3: ibandronate [Bonviva/Boniva]

64

Little Rock | Arkansas | United States | -92.28959 | 34.74648 Irvine | California | United States | -117.82311 | 33.66946 Rancho Mirage | California | United States | -116.41279 | 33.73974 Leesburg | Florida | United States | -81.87786 | 28.81082 Gainesville | Georgia | United States | -83.82407 | 34.29788 Coeur d'Alene | Idaho | United States | -116.78047 | 47.67768 Bethesda | Maryland | United States | -77.10026 | 38.98067 St Louis | Missouri | United States | -90.19789 | 38.62727 Billings | Montana | United States | -108.50069 | 45.78329 Omaha | Nebraska | United States | -95.94043 | 41.25626 Albuquerque | New Mexico | United States | -106.65114 | 35.08449 New York | New York | United States | -74.00597 | 40.71427 Bismarck | North Dakota | United States | -100.78374 | 46.80833 Fargo | North Dakota | United States | -96.7898 | 46.87719 Wyomissing | Pennsylvania | United States | -75.96521 | 40.32954 Rapid City | South Dakota | United States | -103.23101 | 44.08054 San Antonio | Texas | United States | -98.49363 | 29.42412 Virginia Beach | Virginia | United States | -75.97799 | 36.85293 Madison | Wisconsin | United States | -89.40123 | 43.07305 Darlinghurst | N/A | Australia | 151.21925 | -33.87939 Melbourne | N/A | Australia | 144.96332 | -37.814 Nedlands | N/A | Australia | 115.8073 | -31.98184 St Leonards | N/A | Australia | 151.19836 | -33.82344 Sydney | N/A | Australia | 151.20732 | -33.86785 Brussels | N/A | Belgium | 4.34878 | 50.85045 Liège | N/A | Belgium | 5.56749 | 50.63373 Toronto | Ontario | Canada | -79.39864 | 43.70643 Laval | Quebec | Canada | -73.692 | 45.56995 Montreal | Quebec | Canada | -73.58781 | 45.50884 Montreal | Quebec | Canada | -73.58781 | 45.50884 Saskatoon | Saskatchewan | Canada | -106.66892 | 52.13238 Pilsen | N/A | Czechia | 13.37759 | 49.74747 Prague | N/A | Czechia | 14.42076 | 50.08804 Aalborg | N/A | Denmark | 9.9187 | 57.048 Aarhus | N/A | Denmark | 10.21076 | 56.15674 Ballerup Municipality | N/A | Denmark | 12.36328 | 55.73165 Copenhagen | N/A | Denmark | 12.56553 | 55.67594 Vejle | N/A | Denmark | 9.5357 | 55.70927 Lyon | N/A | France | 4.84671 | 45.74846 Orléans | N/A | France | 1.90389 | 47.90289 Berlin | N/A | Germany | 13.41053 | 52.52437 Bochum | N/A | Germany | 7.21648 | 51.48165 Hamburg | N/A | Germany | 9.99302 | 53.55073 Budapest | N/A | Hungary | 19.04045 | 47.49835 Arenzano | N/A | Italy | 8.68315 | 44.40521 Siena | N/A | Italy | 11.33064 | 43.31822 Valeggio sul Mincio | N/A | Italy | 10.73635 | 45.35333 Mexico City | N/A | Mexico | -99.12766 | 19.42847 Monterrey | N/A | Mexico | -100.31721 | 25.68435 Haugesund | N/A | Norway | 5.268 | 59.41378 Oslo | N/A | Norway | 10.74609 | 59.91273 Stavanger | N/A | Norway | 5.73332 | 58.97005 Grudziądz | N/A | Poland | 18.75366 | 53.48411 Krakow | N/A | Poland | 19.93658 | 50.06143 Krakow | N/A | Poland | 19.93658 | 50.06143 Cape Town | N/A | South Africa | 18.42322 | -33.92584 Pretoria | N/A | South Africa | 28.18783 | -25.74486 Sommerset West | N/A | South Africa | N/A | N/A Barcelona | N/A | Spain | 2.15899 | 41.38879 Madrid | N/A | Spain | -3.70256 | 40.4165 Santander | N/A | Spain | -3.80444 | 43.46472 Aberdeen | N/A | United Kingdom | -2.09814 | 57.14369 Manchester | N/A | United Kingdom | -2.23743 | 53.48095 Newcastle upon Tyne | N/A | United Kingdom | -1.61396 | 54.97328

0

NCT00048074

[ 3, 4 ]

63

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

null

This study will assess the safety and pharmacokinetics of Valcyte syrup in pediatric solid organ transplant recipients. The anticipated time on study treatment is 3-12 months and the target sample size is less than 100 individuals.

null

Cytomegalovirus Infections

null

3

arm 1: Eligible participants aged \<= 2 years received valganciclovir up to maximum of 900 milligrams (mg) once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose = 7 \* body surface area (BSA) \* creatinine clearance (CrCLS). arm 2: Eligible participants aged \>2 to \<12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose = 7 \* BSA \* CrCLS. arm 3: Eligible participants aged \>= 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose = 7 \* BSA \* CrCLS.

[ 0, 0, 0 ]

1

[ 0 ]

intervention 1: po daily (dose based on body surface area and CrCL)

intervention 1: valganciclovir [Valcyte]

17

0

NCT00090766

[ 3 ]

96

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

This study will evaluate visual improvement in patients treated with Immune Globulin Intravenous (Human), 10% Caprylate/Chromatography Purified (IGIV-C) or placebo who have Age-Related Macular Degeneration (AMD) with occult Choroidal Neovascularization (CNV).

The purpose of this trial is to investigate the effect of IGIV-C in subjects suffering from AMD with occult CNV where fewer treatment options exist for patients with this disease form. This study is designed as a randomized, double-blind, parallel group, placebo-controlled prospective trial. Sixty patients, 30 per treatment group, with newly diagnosed pure occult CNV defined by angiography diagnostic criteria will be enrolled. If a subject has more than one eye affected with occult CNV, the eye with the better vision as measured by visual acuity ( Logarithm of the Minimum Angle of Resolution \[LogMAR\] score) will be entered as the study eye. Patients will be randomized to receive either IGIV-C at a dose of 2 g/kg body weight (bw) over 5 consecutive days or matching placebo. Additional 2 study drug treatment courses (IGIV-C or matching placebo) will be administered every 4 weeks at the same dose of 2 g/kg bw given over 5 days. Subjects' visual acuity will be measured and reported as LogMAR at screening, week 0 (baseline), day 5, week 4, week 8 and week 12. If at anytime during the study the subject's visual acuity worsens by ≥ 2 lines (0.2 on the LogMAR score), then a slit lamp examination will be performed and an angiogram will be conducted; the patient would be discontinued if the worsening is due to some other reason outside of the occult CNV or if the disease has changed from pure occult to the classic or mixed form. Subjects will be evaluated for efficacy (LogMAR score) at endpoint (at week 12 or at last LogMAR assessment at or after week 8, if the subject prematurely discontinues the trial). At the end of the treatment period (week 12), patients will be entered into a 3 month observation period with monthly visual acuity LogMAR score assessments.

Macular Degeneration

null

2

arm 1: None arm 2: None

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: The dose per infusion cycle was 2 g/kg body weight over 5 consecutive days (= 4 mL/kg body weight/infusion). The infusion duration was approximately 1.5 - 2 h. intervention 2: Albumin (Human) 20% or 25% will be diluted with 5% glucose to a final concentration of 0.1%.

intervention 1: Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified intervention 2: Albumin (Human) 25%, United States Pharmacopeia (USP)

7

Aachen | N/A | Germany | 6.08342 | 50.77664 Cologne | N/A | Germany | 6.95 | 50.93333 Duisburg | N/A | Germany | 6.76516 | 51.43247 Düsseldorf | N/A | Germany | 6.77616 | 51.22172 Essen | N/A | Germany | 7.01228 | 51.45657 Freiburg im Breisgau | N/A | Germany | 7.85222 | 47.9959 Tübingen | N/A | Germany | 9.05222 | 48.52266

0

NCT00220805

[ 5 ]

52

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

null

This study compares the effect of Ferrlecit® (a form of intravenous iron) to ferrous sulfate (a form of oral iron) in treating anemia and iron deficiency in chronic kidney disease patients who are receiving erythropoietic agents, such as Procrit® and Aranesp®.

null

Anemia, Iron-Deficiency Kidney Failure, Chronic

Iron deficiency Anemia Chronic kidney disease Erythropoietic agents Sodium Ferric Gluconate Anemia, Iron-Deficiency/drug therapy/etiology Kidney Failure, Chronic/blood/complications/therapy Erythropoietin, Recombinant/adverse effects/therapeutic use

null

2

arm 1: None arm 2: None

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: Sodium ferric gluconate complex in sucrose, 250 mg IV weekly for 4 doses intervention 2: ferrous sulfate 325 mg three times daily for 6 weeks

intervention 1: Sodium Ferric Gluconate complex in sucrose intervention 2: Ferrous sulfate tablets

24

0

NCT00224042

[ 5 ]

93

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

1FEMALE

null

This study will evaluate the effectiveness of fluoxetine versus placebo in reducing the rate of relapse of anorexia nervosa (AN) and enhancing the psychosocial and behavioral recovery of people who have been treated for AN.

Anorexia nervosa (AN), a type of eating disorder, is a serious psychiatric illness that is characterized by an extreme loss of appetite. People with AN view themselves as overweight and cannot bring themselves to eat, even though most are dangerously thin. Signs of the disorder include unusual eating habits, such as avoiding food and meals, picking out a few foods and eating them in small quantities, or carefully weighing and portioning food. Some people with AN fully recover after a single episode, some have a fluctuating pattern of weight gain and relapse, and others experience a chronic course of illness over many years. Effective drugs to treat the disorder are lacking. In addition, most past research has examined the effect of medications during the initial phase of treatment, a time when AN patients may not respond to medication because of the acute effects of starvation. Fluoxetine is a selective serotonin reuptake inhibitor (SSRI) that is commonly used to treat depression. This study will evaluate the effectiveness of fluoxetine versus placebo in reducing the rate of relapse of AN and enhancing the psychosocial and behavioral recovery of women who have already been treated for AN. Participants in this double-blind study will be recruited immediately following completion of a treatment program for AN, in which they maintained a body mass index (BMI) of at least 19 kg/m2 for two weeks. Upon study entry, participants will be randomly assigned to receive either fluoxetine or placebo for 12 months. Participants will begin receiving medication one week prior to discharge from the hospital in which they received care for AN. Medication doses will be increased up to a target dose of 60 mg per day, and will not exceed 80 mg per day. Participants will receive 50 sessions of cognitive-behavioral therapy, lasting approximately 45 minutes each and occurring twice weekly for the first month following discharge from the hospital. After the first month, therapy sessions will occur once weekly until Month 9 and then every other week until Month 12. Participants will also report to the study site to meet with a psychiatrist once a week for the first month following discharge and then every other week for the remainder of the study. General medical status, evidence of AN relapse, medication dose, and side effects will be assessed at these visits. Upon completing treatment, follow-up telephone calls will occur at Months 15 and 21, and follow-up visits will be held at Months 18 and 24. Psychopathology associated with AN, including concern with weight and shape, depressive symptoms, anxiety, and obsessive behavior, will be assessed.

Anorexia Nervosa Eating Disorders

Depression

null

2

arm 1: fluoxetine up to 80 mg per day arm 2: Placebo

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: None intervention 2: None

intervention 1: Fluoxetine intervention 2: Placebo

1

New York | New York | United States | -74.00597 | 40.71427

0

NCT00288574

[ 4 ]

452

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

null

This was a multi-center, open-label, non-comparative study that evaluated the long-term safety and efficacy profile of Adapalene/Benzoyl Peroxide Gel. Subjects were evaluated at Baseline, Weeks 1 and 2, and Months 1, 2, 4, 6, 8, 10, and 12. Safety was evaluated by spontaneous reports of Adverse Events (AEs), the Local Tolerability Assessment (Erythema, Scaling, Dryness, and Stinging/Burning), routine laboratory testing (hematology, blood chemistry, and urinalysis), and monitoring of suspected sensitizations. Efficacy was evaluated by analysis of Percent Change from Baseline in Inflammatory, Noninflammatory, and Total Lesion Counts, and by the Subject's Assessment of Acne.

null

Acne Vulgaris

Acne Vulgaris Adapalene Benzoyl Peroxide

null

1

arm 1: Participants were treated with adapalene 0.1 percent (%) \[weight by weight (W/W)\] and benzoyl peroxide 2.5 percent (%) (W/W) gel topically to the face and trunk area once daily in the evening.

[ 0 ]

1

[ 0 ]

intervention 1: Adapalene 0.1 percent (%) \[weight by weight (W/W)\] and benzoyl peroxide 2.5 % (W/W) gel topically daily in the evening.

intervention 1: Adapalene/Benzoyl Peroxide

1

Portland | Oregon | United States | -122.67621 | 45.52345

0

NCT00446043

[ 3 ]

50

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

The primary objective of this study is to explore the dose-response relation of MK-8616 (Org 25969) given as a reversal agent of Zemuron® at 1 to 2 post tetanic counts (PTCs); both Zemuron® and MK-8616 are administered by intravenous (iv) infusion. Another goal of the study is to evaluate the safety of single doses of MK-8616 administered to participants of American Society of Anesthesiologists (ASA) Physical Status Class 1 (otherwise normal, healthy participant); Class 2 (participant with a mild systemic disease); or Class 3 (participant with a severe systemic disease that limits activity, but is not incapacitating).

null

Neuromuscular Blockade

null

10

arm 1: Participants (ASA Class 1 to 3) will receive an iv bolus of Zemuron® 0.6 mg/kg followed by MK-8616 0.5 mg/kg iv during a single study session. MK-8616 will be administered once Zemuron®-induced neuromuscular blockade (NMB) reaches 1 to 2 PTCs. arm 2: Participants (ASA Class 1 to 3) will receive an iv bolus of Zemuron® 1.2 mg/kg followed by MK-8616 0.5 mg/kg iv during a single study session. MK-8616 will be administered once Zemuron®-induced NMB reaches 1 to 2 PTCs. arm 3: Participants (ASA Class 1 to 3) will receive an iv bolus of Zemuron® 0.6 mg/kg followed by MK-8616 1.0 mg/kg iv during a single study session. MK-8616 will be administered once Zemuron®-induced NMB reaches 1 to 2 PTCs. arm 4: Participants (ASA Class 1 to 3) will receive an iv bolus of Zemuron® 1.2 mg/kg followed by MK-8616 1.0 mg/kg iv during a single study session. MK-8616 will be administered once Zemuron®-induced NMB reaches 1 to 2 PTCs. arm 5: Participants (ASA Class 1 to 3) will receive an iv bolus of Zemuron® 0.6 mg/kg followed by MK-8616 2.0 mg/kg iv during a single study session. MK-8616 will be administered once Zemuron®-induced NMB reaches 1 to 2 PTCs. arm 6: Participants (ASA Class 1 to 3) will receive an iv bolus of Zemuron® 1.2 mg/kg followed by MK-8616 2.0 mg/kg iv during a single study session. MK-8616 will be administered once Zemuron®-induced NMB reaches 1 to 2 PTCs. arm 7: Participants (ASA Class 1 to 3) will receive an iv bolus of Zemuron® 0.6 mg/kg followed by MK-8616 4.0 mg/kg iv during a single study session. MK-8616 will be administered once Zemuron®-induced NMB reaches 1 to 2 PTCs. arm 8: Participants (ASA Class 1 to 3) will receive an iv bolus of Zemuron® 1.2 mg/kg followed by MK-8616 4.0 mg/kg iv during a single study session. MK-8616 will be administered once Zemuron®-induced NMB reaches 1 to 2 PTCs. arm 9: Participants (ASA Class 1 to 3) will receive an iv bolus of Zemuron® 0.6 mg/kg followed by MK-8616 8.0 mg/kg iv during a single study session. MK-8616 will be administered once Zemuron®-induced NMB reaches 1 to 2 PTCs. arm 10: Participants (ASA Class 1 to 3) will receive an iv bolus of Zemuron® 1.2 mg/kg followed by MK-8616 8.0 mg/kg iv during a single study session. MK-8616 will be administered once Zemuron®-induced NMB reaches 1 to 2 PTCs.

[ 0, 0, 0, 0, 0, 0, 0, 0, 0, 0 ]

2

[ 0, 0 ]

intervention 1: MK-8616 will be administered at doses of 0.5, 1.0, 2.0, 4.0 and 8.0 mg/kg iv as a 30-second infusion. Doses are based on actual body weight. intervention 2: Zemuron® (0.6 or 1.2 mg/kg, iv) will be administered as a 10-second bolus infusion to achieve 1 to 2 PTCs. If needed, a maintenance dose of 0.15 mg/kg will be given. Doses are based on actual body weight.

intervention 1: MK-8616 intervention 2: Zemuron®

0

null

0

NCT03519867

[ 3 ]

91

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

null

This study will determine the appropriate dose and frequency of administration of iv Mircera maintenance therapy in hemodialysis patients with chronic renal anemia who were previously receiving iv epoetin. The anticipated time on study treatment is 3-12 months and the target sample size is \<100 individuals.

null

Anemia

null

6

arm 1: Eligible participant will be administered RO0503821 (methoxy polyethylene glycol-epoetin beta \[Mircera\]) intravenously (IV) using a dose conversion factor of 0.25/150 microgram (mcg)/kilogram (kg) of the previous weekly erythropoiesis stimulating agents (ESA) dose, (equal to 62.50% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each). arm 2: Eligible participant will be administered RO0503821 IV using a dose conversion factor of 0.25/150 mcg/kg of the previous weekly ESA dose, (equal to 62.50% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each). arm 3: Eligible participant will be administered RO0503821 IV using a dose conversion factor of 0.40/150 mcg/kg of the previous weekly ESA dose, (equal to100% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each). arm 4: Eligible participant will be administered RO0503821 IV using a dose conversion factor of 0.40/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each). arm 5: Eligible participant will be administered RO0503821 IV using a dose conversion factor of 0.60/150 mcg/kg of the previous weekly ESA dose, (equal to150% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each). arm 6: Eligible participant will be administered RO0503821 IV using a dose conversion factor of 0.60/150 mcg/kg of the previous weekly ESA dose, (equal to150% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each).

[ 0, 0, 0, 0, 0, 0 ]

1

[ 0 ]

intervention 1: Differing doses and frequencies of iv administration

intervention 1: methoxy polyethylene glycol-epoetin beta [Mircera]

14

0

NCT00048035

[ 5 ]

90

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

Atopic dermatitis is a chronic relapsing disease with acute flares. The standard therapy is to treat acute flares using topical medications. The two most common classes of topical medications for atopic dermatitis (AD) are topical corticosteroids and topical calcineurin inhibitors. Pimecrolimus and topical corticosteroids exert their activity by different mechanisms, there may be a synergistic effect of the combination therapy. Therefore, a combination therapy may provide a faster resolution of severe skin lesions and consequently reduce the duration of the topical corticosteroid treatment. Another benefit of the combination therapy maybe the use of a lower potency corticosteroid to achieve the same degree of clearance. The hypothesis of this trial is that the combination of the two agents will lead to faster clearance than the single agent of topical corticosteroids.

This trial is a double-blind controlled trial of fluticasone cream daily and pimecrolimus cream BID versus fluticasone cream daily and placebo cream BID for the treatment of acute flares of atopic dermatitis. While pimecrolimus cream 1% has been proven to be effective in mild and moderate Atopic dermatitis (AD), there is a need for a fast control of severe skin lesions. On the other hand, reducing the duration of the topical corticosteroid treatment is a reasonable approach to minimize the occurrence of adverse effects. Because pimecrolimus and topical corticosteroids exert their activity by different mechanisms, there may be a synergistic effect of the combination therapy. Therefore, a combination therapy may provide a faster resolution of severe skin lesions and consequently reduce the duration of the topical corticosteroid treatment. Another benefit of the combination therapy maybe the use of a lower potency corticosteroid to achieve the same degree of clearance. In vitro data have demonstrated that a combination of steroids and tacrolimus has synergistic effects on in vitro human lymphocyte proliferation. In addition, it has previously been reported, in a pilot investigation in two subjects, that a combination regimen of pimecrolimus 1% twice a day and fluticasone propionate cream 0.05% once daily was superior to fluticasone propionate cream 0.05% once daily in the acute treatment of atopic dermatitis (AD). This study is conducted to validate these findings in a larger number of patients.

Atopic Dermatitis

THerapy for acute moderate to severe flares

null

2

arm 1: Placebo cream arm 2: None

[ 2, 1 ]

2

[ 0, 0 ]

intervention 1: Pimecrolimus cream twice a day and fluticasone cream once a day intervention 2: apply daily with fluticasone cream for flares

intervention 1: Combination of pimecrolimus and fluticasone intervention 2: pimecrolimus

3

0

NCT00119158

[ 3 ]

270

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

To evaluate the clinical and microbial efficacy of ISV-403 administered three times a day (TID) for 5 days compared to vehicle three times a day for 5 days in the treatment of bacterial conjunctivitis

null

Bacterial Conjunctivitis

null

2

arm 1: ISV-403 0.6% arm 2: Vehicle of ISV-403

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: 0.6% TID, 5 days intervention 2: Vehicle of ISV-403 TID, 5 days

intervention 1: ISV-403 intervention 2: Vehicle

0

null

0

NCT00622908

[ 3 ]

63

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

Explore weight gain in HIV-positive patients who have weight loss associated with AIDS-related wasting (anorexia/cachexia). Patients are treated for 12 weeks with either megestrol acetate oral suspension nanocrystal dispersion formulation, or megestrol acetate oral suspension original formulation

null

HIV Infections Cachexia Anorexia AIDS Wasting Syndrome HIV Wasting Syndrome

Weight loss Cachexia Anorexia Megestrol acetate oral suspension Nanocrystal dispersion Nanocrystal technology Body weight changes AIDS wasting HIV wasting Emaciation Megace ES Megace Treatment Experienced

null

2

arm 1: Megestrol acetate oral suspension nanocrystal dispersion formulation 115 mg/mL arm 2: Megestrol acetate oral suspension micronized formulation 60 mg/mL

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: Megestrol acetate oral suspension nanocrystal dispersion 115 mg/mL administered as 575 mg once per day (5 mL dose) intervention 2: Megestrol acetate oral suspension 40 mg/mL administered as 800 mg once per day (20 mL dose)

intervention 1: Megestrol acetate oral suspension nanocrystal dispersion 115 mg/mL intervention 2: Megestrol acetate oral suspension 40 mg/mL

12

0

NCT00637572

[ 2 ]

33

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

null

To determine the maximum tolerated dose of E7389 in patients with advanced solid tumors that have progressed following standard therapy or for which no standard therapy exists.

null

Advanced Solid Tumors

Metastatic Tumors Advanced Solid Tumors Stage IV Tumors Solid Tumors Recurrent Solid Tumors

null

1

arm 1: None

[ 0 ]

1

[ 0 ]

intervention 1: E7389 Dose-escalation starting at 0.25 mg/m\^2 intravenous on Days 1, 8, and 15 of a 28 day cycle.

intervention 1: E7389

2

0

NCT00069264

[ 4 ]

170

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

null

This study will assess the effect of anemia correction with NeoRecormon on cardiac structure and function in patients with early diabetic nephropathy. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.

null

Anemia

null

2

arm 1: Along with their standard treatment participants will receive epoetin beta at a starting dose of 2000 International Units (IU) subcutaneously (SC) once weekly to reach and maintain target hemoglobin (Hb) between 13 and 15 grams per deciliter (g/dL), for 15 months. Epoetin beta doses will be adjusted according to individual participant's Hb level. Standard treatment will be as per investigator discretion. arm 2: Participants will receive their standard treatment for 15 months but no treatment for anemia correction unless Hb level will be less than (\<) 10.5 g/dL on 2 consecutive visits of 2 weeks interval or the Hb level will be \<10 g/dL on a single determination. In such cases participants could receive epoetin beta at a starting dose of 2000 IU SC once weekly to reach and maintain a target Hb level of 10.5 to 11.5 g/dL. Standard treatment will be as per investigator discretion.

[ 0, 1 ]

1

[ 0 ]

intervention 1: None

intervention 1: Epoetin beta

63

Linz | N/A | Austria | 14.28611 | 48.30639 São Paulo | N/A | Brazil | -46.63611 | -23.5475 Jihlava | N/A | Czechia | 15.59124 | 49.3961 Liberec | N/A | Czechia | 15.05619 | 50.76711 Copenhagen | N/A | Denmark | 12.56553 | 55.67594 Roskilde | N/A | Denmark | 12.08035 | 55.64152 Jyväskylä | N/A | Finland | 25.72088 | 62.24147 Heidelberg | N/A | Germany | 8.69079 | 49.40768 München | N/A | Germany | 13.31243 | 51.60698 Alexandroupoli | N/A | Greece | 25.87644 | 40.84995 Athens | N/A | Greece | 23.72784 | 37.98376 Ioannina | N/A | Greece | 20.85189 | 39.66486 Nikaia | N/A | Greece | 23.65 | 37.96667 Thessaloniki | N/A | Greece | 22.93086 | 40.64361 Thessaloniki | N/A | Greece | 22.93086 | 40.64361 Véria | N/A | Greece | 22.55173 | 37.19027 Budapest | N/A | Hungary | 19.04045 | 47.49835 Budapest | N/A | Hungary | 19.04045 | 47.49835 Miskolc | N/A | Hungary | 20.77806 | 48.10306 Pécs | N/A | Hungary | 18.23083 | 46.0725 Szombathely | N/A | Hungary | 16.62155 | 47.23088 Ancona | N/A | Italy | 13.5103 | 43.60717 Cagliari | N/A | Italy | 9.11917 | 39.23054 Caserta | N/A | Italy | 14.33231 | 41.07262 Cinisello Balsamo | N/A | Italy | 9.21495 | 45.55823 Desio | N/A | Italy | 9.20249 | 45.61831 Lecco | N/A | Italy | 9.39704 | 45.85589 Messina | N/A | Italy | 15.55256 | 38.19394 Milan | N/A | Italy | 12.59836 | 42.78235 Milan | N/A | Italy | 12.59836 | 42.78235 Chihuahua City | N/A | Mexico | -106.08889 | 28.63528 Mexico City | N/A | Mexico | -99.12766 | 19.42847 Monterrey | N/A | Mexico | -100.31721 | 25.68435 Bialystok | N/A | Poland | 23.16433 | 53.13333 Katowice | N/A | Poland | 19.02754 | 50.25841 Radom | N/A | Poland | 21.14714 | 51.40253 Moscow | N/A | Russia | 37.61556 | 55.75222 Moscow | N/A | Russia | 37.61556 | 55.75222 Moscow | N/A | Russia | 37.61556 | 55.75222 Moscow | N/A | Russia | 37.61556 | 55.75222 Singapore | N/A | Singapore | 103.85007 | 1.28967 A Coruña | N/A | Spain | -8.396 | 43.37135 Barakaldo | N/A | Spain | -2.98813 | 43.29639 Barcelona | N/A | Spain | 2.15899 | 41.38879 Galdakao | N/A | Spain | -2.8429 | 43.23073 Madrid | N/A | Spain | -3.70256 | 40.4165 Madrid | N/A | Spain | -3.70256 | 40.4165 Valencia | N/A | Spain | -0.37966 | 39.47391 Stockholm | N/A | Sweden | 18.06871 | 59.32938 Bangkok | N/A | Thailand | 100.50144 | 13.75398 Bangkok | N/A | Thailand | 100.50144 | 13.75398 Bangkok | N/A | Thailand | 100.50144 | 13.75398 Chiang Mai | N/A | Thailand | 98.98468 | 18.79038 Chon Buri | N/A | Thailand | 100.98345 | 13.3622 Belfast | N/A | United Kingdom | -5.92541 | 54.59682 Cambridge | N/A | United Kingdom | 0.11667 | 52.2 London | N/A | United Kingdom | -0.12574 | 51.50853 London | N/A | United Kingdom | -0.12574 | 51.50853 London | N/A | United Kingdom | -0.12574 | 51.50853 Middlesbrough | N/A | United Kingdom | -1.23483 | 54.57623 Salford | N/A | United Kingdom | -2.29042 | 53.48771 Sheffield | N/A | United Kingdom | -1.4659 | 53.38297 Wrexham | N/A | United Kingdom | -2.99132 | 53.04664

0

NCT00354341

[ 3 ]

137

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

null

This study will determine the appropriate dose and frequency of administration of sc Mircera maintenance therapy in dialysis patients with chronic renal anemia who were previously receiving sc epoetin alfa or beta. The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals.

null

Anemia

null

9

arm 1: Eligible participant will be administered RO0503821 (methoxy polyethylene glycol-epoetin beta \[Mircera\]) SC using a dose conversion factor of 0.4/150 microgram (mcg)/ kilogram (kg) of the previous weekly erythropoiesis stimulating agents (ESA) dose, (equal to 50% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each). arm 2: Eligible participant will be administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each). arm 3: Eligible participant will be administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each). arm 4: Eligible participant will be administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each). arm 5: Eligible participant will be administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each). arm 6: Eligible participant will be administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each). arm 7: Eligible participant will be administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each). arm 8: Eligible participant will be administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each). arm 9: Eligible participant will be administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each).

[ 0, 0, 0, 0, 0, 0, 0, 0, 0 ]

1

[ 0 ]

intervention 1: Differing doses and frequencies of sc administration

intervention 1: methoxy polyethylene glycol-epoetin beta [Mircera]

23

Los Angeles | California | United States | -118.24368 | 34.05223 San Jose | California | United States | -121.89496 | 37.33939 Boston | Massachusetts | United States | -71.05977 | 42.35843 Cleveland | Ohio | United States | -81.69541 | 41.4995 Houston | Texas | United States | -95.36327 | 29.76328 Morgantown | West Virginia | United States | -79.9559 | 39.62953 Berlin | N/A | Germany | 13.41053 | 52.52437 Mannheim | N/A | Germany | 8.46694 | 49.4891 Villingen-Schwenningen | N/A | Germany | 8.49358 | 48.06226 Wiesloch | N/A | Germany | 8.69846 | 49.29504 Bari | N/A | Italy | 16.86982 | 41.12066 Bergamo | N/A | Italy | 9.66721 | 45.69601 Lecco | N/A | Italy | 9.39704 | 45.85589 Lodi | N/A | Italy | 9.50085 | 45.30989 Milan | N/A | Italy | 12.59836 | 42.78235 Modena | N/A | Italy | 10.92539 | 44.64783 Pavia | N/A | Italy | 9.15917 | 45.19205 Vicenza | N/A | Italy | 11.5475 | 45.54672 Barcelona | N/A | Spain | 2.15899 | 41.38879 Madrid | N/A | Spain | -3.70256 | 40.4165 Madrid | N/A | Spain | -3.70256 | 40.4165 Málaga | N/A | Spain | -4.42034 | 36.72016 Santander | N/A | Spain | -3.80444 | 43.46472

0

NCT00364832

[ 3 ]

15

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

Current therapies for Stage IV Pancreatic Cancer provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of Stage IV Pancreatic Cancer. PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on patients with Stage IV Pancreatic Cancer.

Stage IV Pancreatic Cancer patients receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues up to 12 months in the absence of disease progression or unacceptable toxicity. OBJECTIVES: * To determine the efficacy of Antineoplaston therapy in patients with Stage IV Pancreatic Cancer, as measured by an objective response to therapy (complete response, partial response or stable disease). * To determine the safety and tolerance of Antineoplaston therapy in patients with Stage IV Pancreatic Cancer. * To determine objective response, tumor size is measured utilizing MRI scans, which are performed every 8 weeks for the first two years, every 3 months for the third and fourth years, every 6 months for the 5th and sixth years, and annually thereafter.

Stage IV Pancreatic Cancer

Adenocarcinoma of the pancreas

null

1

arm 1: Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.

[ 0 ]

1

[ 0 ]

intervention 1: Patients with Stage IV Pancreatic Cancer will receive Antineoplaston therapy (Atengenal + Astugenal). The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1.

intervention 1: Antineoplaston therapy (Atengenal + Astugenal)

1

Houston | Texas | United States | -95.36327 | 29.76328

0

NCT00003531

[ 4 ]

673

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

null

This study will assess the efficacy and safety of intravenous Mircera, given as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving iv epoetin. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.

null

Anemia

null

3

arm 1: Participants received RO0503821 (Mircera \[methoxy polyethylene glycol-epoetin beta\]) once every two weeks intravenously for 52 weeks. Participants received a starting dose of RO0503821 (60, 100, or 180 microgram \[mcg\]) that was based on the Epoetin dose (\<8000, 8000-16000, \>16000 International units \[IU\]/Week) administered during the week preceding the switch to the study drug. arm 2: Participants received RO0503821 once every four weeks intravenously for 52 weeks. Participants received a starting dose of RO0503821 (120, 200, or 360 mcg) that was based on the Epoetin dose (\<8000, 8000-16000, \>16000 IU/Week) administered during the week preceding the switch to the study drug. arm 3: Participants received their ongoing weekly intravenous dose of Epoetin alfa or beta one, two or three times weekly for 52 weeks.

[ 0, 0, 1 ]

3

[ 0, 0, 0 ]

intervention 1: intravenously 3 times weekly for 52 weeks, as prescribed intervention 2: 60, 100, or 180 microgram (mcg) (starting dose) once every two weeks intravenously for 52 weeks. intervention 3: 120, 200 or 360 mcg (starting dose) once every four weeks intravenously for 52 weeks.

intervention 1: Epoetin alfa or beta intervention 2: RO0503821 (1x/2 Weeks) intervention 3: RO0503821 (1x/4 Weeks)

99

0

NCT00077610

[ 4 ]

313

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

null

This study will assess the efficacy and safety of intravenous (iv) Mircera given as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving iv darbepoetin alfa. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.

null

Anemia

null

2

arm 1: Eligible participants will be administered with RO0503821 (\[methoxy polyethylene glycol-epoetin beta\] {Mircera}) intravenously (IV), every 2 weeks during Weeks 1 through 52. The starting dose of RO0503821 (60, 100, or 180 micro gram \[µg\]) was based on the dose of darbepoetin alfa at the time of randomization (\< 40, 40 to 80, or \> 80 µg per week, respectively). arm 2: Eligible participants will be administered with darbepoetin alfa IV, every week or every 2 weeks during Weeks 1 through 52.

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: Darbepoetin alfa was administered IV, every week or every 2 weeks during Weeks 1 through 52. intervention 2: RO0503821 was administered IV, every 2 weeks during Weeks 1 through 52. The starting dose of RO0503821 (60, 100, or 180 micro gram \[µg\]) was based on the dose of darbepoetin alfa at the time of randomization (\< 40, 40 to 80, or \> 80 µg per week, respectively).

intervention 1: Darbepoetin alfa intervention 2: methoxy polyethylene glycol-epoetin beta [Mircera]

48

Blacktown | N/A | Australia | 150.91667 | -33.76667 Brisbane | N/A | Australia | 153.02809 | -27.46794 Clayton | N/A | Australia | 145.11667 | -37.91667 Gosford | N/A | Australia | 151.34399 | -33.4244 Parkville | N/A | Australia | 144.95 | -37.78333 Sydney | N/A | Australia | 151.20732 | -33.86785 Graz | N/A | Austria | 15.45 | 47.06667 Aalst | N/A | Belgium | 4.0355 | 50.93604 Brussels | N/A | Belgium | 4.34878 | 50.85045 Brussels | N/A | Belgium | 4.34878 | 50.85045 Liège | N/A | Belgium | 5.56749 | 50.63373 Calgary | Alberta | Canada | -114.08529 | 51.05011 Edmonton | Alberta | Canada | -113.46871 | 53.55014 Kamloops | British Columbia | Canada | -120.3192 | 50.66648 Vancouver | British Columbia | Canada | -123.11934 | 49.24966 Winnipeg | Manitoba | Canada | -97.14704 | 49.8844 Halifax | Nova Scotia | Canada | -63.57688 | 44.64269 Kitchener | Ontario | Canada | -80.5112 | 43.42537 Mississauga | Ontario | Canada | -79.6583 | 43.5789 Aalborg | N/A | Denmark | 9.9187 | 57.048 Odense | N/A | Denmark | 10.38831 | 55.39594 Roskilde | N/A | Denmark | 12.08035 | 55.64152 HUS | N/A | Finland | N/A | N/A Aubervilliers | N/A | France | 2.38333 | 48.91667 Montpellier | N/A | France | 3.87635 | 43.61093 Nice | N/A | France | 7.26608 | 43.70313 Strasbourg | N/A | France | 7.74553 | 48.58392 Tarbes | N/A | France | 0.07139 | 43.23407 Toulouse | N/A | France | 1.44367 | 43.60426 Hannoversch Münden | N/A | Germany | 9.65046 | 51.41505 Nuremberg | N/A | Germany | 11.07752 | 49.45421 Villingen-Schwenningen | N/A | Germany | 8.49358 | 48.06226 Bergamo | N/A | Italy | 9.66721 | 45.69601 Lecco | N/A | Italy | 9.39704 | 45.85589 Livorno | N/A | Italy | 10.32615 | 43.54427 Messina | N/A | Italy | 15.55256 | 38.19394 Pavia | N/A | Italy | 9.15917 | 45.19205 Badalona | N/A | Spain | 2.24741 | 41.45004 Barcelona | N/A | Spain | 2.15899 | 41.38879 Córdoba | N/A | Spain | -4.77275 | 37.89155 Madrid | N/A | Spain | -3.70256 | 40.4165 Oviedo | N/A | Spain | -5.84476 | 43.36029 Salamanca | N/A | Spain | -5.66388 | 40.96882 Santander | N/A | Spain | -3.80444 | 43.46472 Karlstad | N/A | Sweden | 13.50357 | 59.3793 Stockholm | N/A | Sweden | 18.06871 | 59.32938 Aarau | N/A | Switzerland | 8.04422 | 47.39254 Lausanne | N/A | Switzerland | 6.63282 | 46.516

0

NCT00077766

[ 2, 3 ]

28

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

1FEMALE

false

Compatibility of the topotecan therapy in combination with carboplatin.

The aim of the study was to confirm the tolerability of 3-day topotecan therapy in combination with carboplatin in accordance with published data and to investigate the tolerability of continued therapy until disease progression or up to a maximum of 12 months.

Ovarian Cancer

platin-resistant

null

2

arm 1: dose level 0: Topotecan 1mg/m2/d on day 1-3, q 21d (+ Carboplatin AUC 5 on day 3 after Topotecan application) If dose limiting toxicity (DLT) is present then Topotecan dose will be reduced to dose level -1 (dose level -1: Topotecan 0.75 mg/m2/d on day 1-3, q 21d (+ Carboplatin AUC 5 on day 3 after Topotecan application)) A DLT is present if a patient has a postponement due to hematologic toxicity of more than 7 days within the first four courses at dose level 0. arm 2: dose level 0: Topotecan 1mg/m2/d on day 1-3, q 21d (+ Carboplatin AUC 5 on day 3 after Topotecan application) If dose limiting toxicity (DLT) is present then Topotecan dose will be reduced to dose level -1 (dose level -1: Topotecan 0.75 mg/m2/d on day 1-3, q 21d (+ Carboplatin AUC 5 on day 3 after Topotecan application)) A DLT is present if a patient has a postponement due to hematologic toxicity of more than 7 days within the first four courses at dose level 0.

[ 0, 0 ]

1

[ 0 ]

intervention 1: Topotecan: 1,0 mg/m²/d, day 1-3; q21d Carboplatin: AUC 5 on day 3 after Topotecan, q21d

intervention 1: Hycamtin

0

null

0

NCT00170625

[ 4 ]

418

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (20 mg) in comparison to the buprenorphine transdermal system (5 mg) and oxycodone immediate release in subjects with moderate to severe osteoarthritis pain currently treated with oral opioids. The double-blind treatment intervention duration is 12 weeks during which time supplemental analgesic medication (acetaminophen, ibuprofen, immediate release oxycodone) will be provided to all subjects in addition to study drug.

Buprenorphine is a synthetic opioid analgesic with over twenty-five years of international clinical experience indicating it to be safe and effective in a variety of therapeutic situations for the relief of moderate to severe pain.

Osteoarthritis

Osteoarthritis, opioid, transdermal

null

3

arm 1: Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear arm 2: Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear arm 3: Oxycodone immediate-release 40 mg (two 5-mg capsules every 6 hours).

[ 1, 0, 0 ]

3

[ 0, 0, 0 ]

intervention 1: Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear intervention 2: Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear intervention 3: Oxycodone immediate-release 40 mg (two 5-mg capsules every 6 hours).

intervention 1: Buprenorphine intervention 2: Buprenorphine intervention 3: oxycodone immediate-release

23

0

NCT00312221

[ 3, 4 ]

72

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

The purpose of this study is to compare ziprasidone (Geodon) monotherapy for the treatment of psychotic major depression (PMD)with an antidepressant/antipsychotic combined therapy.

Psychotic depression is a well-established DSM-IV diagnostic subtype indicating the presence of hallucinations and/or delusions as part of the clinical presentation. Currently the treatment of choice for psychotic depression is either electroconvulsive therapy or combination of antipsychotic and antidepressant medications. Ziprasidone will be compared to standard of care treatment comprising a combination of an antidepressant, sertraline and an antipsychotic, haloperidol, over a 12-week period. An additional 12-week extension phase is also included for responders to the initial study.

Affective Disorders

Psychotic

null

2

arm 1: Subjects in this arm received ziprasidone with a placebo to maintain the blind arm 2: Subjects in this arm received a combination of sertraline and haloperidol with a placebo to maintain the blind. Sertraline dosage was 150-200mg/day and haloperidol was 6-8mg/day based on tolerance.

[ 1, 1 ]

3

[ 0, 0, 0 ]

intervention 1: Target dosage 120-160mg/day based on tolerance intervention 2: Target dosage 150-200mg/day based on tolerance. intervention 3: Target dosage 6-8mg/day based on tolerance.

intervention 1: Ziprasidone intervention 2: Sertraline intervention 3: Haloperidol

3

Los Angeles | California | United States | -118.24368 | 34.05223 Alexandria | N/A | Egypt | 29.91582 | 31.20176 Bangalore | N/A | India | 77.59369 | 12.97194

0

NCT00340379

[ 4 ]

196

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

The purpose of this phase is to evaluate the long-term safety and tolerability of BTDS. Qualified subjects are started on BTDS 5 and the dose may be titrated, if necessary, to a maximum of BTDS 20 to achieve stable pain control.

Buprenorphine is a synthetic opioid analgesic with over 25 years of international clinical experience indicating it to be safe and effective in a variety of therapeutic situations for the relief of moderate to severe pain.

Osteoarthritis

Osteoarthritis Opioid Transdermal

null

1

arm 1: Buprenorphine transdermal patch

[ 0 ]

3

[ 0, 0, 0 ]

intervention 1: Buprenorphine transdermal patch 5 mcg/h applied transdermally for 7-day wear. intervention 2: Buprenorphine transdermal patch 10 mcg/h applied transdermally for 7-day wear. intervention 3: Buprenorphine transdermal patch 20 mcg/h applied transdermally for 7-day wear.

intervention 1: Buprenorphine transdermal patch intervention 2: Buprenorphine transdermal patch intervention 3: Buprenorphine transdermal patch

89

0

NCT01135524

[ 5 ]

19

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

The purpose of this study is to determine the effect of Pandel® (hydrocortisone probutate cream) Cream 0.1% on the Hypothalamic Pituitary Adrenal (HPA) axis in pediatric and adult subjects with either psoriasis or atopic dermatitis involving greater than 20% body surface area.

null

Psoriasis Atopic Dermatitis

null

1

arm 1: Pandel Cream 0.1%

[ 0 ]

1

[ 0 ]

intervention 1: A thin coat of cream will be applied and rubbed into the affected areas, as well as normal skin, twice daily for 21 days

intervention 1: Pandel Cream 0.1%

3

0

NCT01137032

[ 3 ]

604

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

This is a study to evaluate the effectiveness and tolerability of a once-daily oral medication (MK-0873) for the treatment of COPD (chronic obstructive pulmonary disease) to determine whether the study drug leads to an improvement in pulmonary (lung) function, as well as symptoms, and quality of life.

Following a three-week run-in period (Period I) during which participants received placebo, participants entered into a 12-week double-blind treatment period (Period II) during which they received daily doses of either one of three doses of MK-0873 or placebo. Period I and Period II made up the Base Study. Following the 12-week treatment period in the Base Study, participants were invited to continue in an optional 12-week double-blind extension study (Period III, EXT1). Participants who received any dose of MK-0873 in the Base Study continued on MK-0873 2.5 mg daily in Period III while participants in the placebo arm of the Base Study continued on placebo daily. Following EXT1, participants were invited to continue in an optional open-label second extension study (EXT2) which was to last 80 weeks (Period IV: 28 weeks, Period V: 52 weeks). In EXT2, participants who had been taking MK-0873 2.5 mg in the Base Study were allocated to MK-0873 2.5 mg plus usual care, while participants who had been taking the other two doses of MK-0873 or placebo in the Base Study were allocated to either MK-0873 2.5 mg plus usual care or to usual care alone.

Lung Diseases Pulmonary Disease, Chronic Obstructive

null

6

arm 1: Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 2.5 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1) arm 2: Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 1.25 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1) arm 3: Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 0.75 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1) arm 4: Participants receive placebo tablets once daily for 3 weeks in Period I (Base), placebo tablets once daily for 12 weeks in Period II (Base) and placebo tablets once daily for 12 weeks in Period III (EXT1) arm 5: Participants receive MK-0873 2.5 mg tablets once daily plus usual care (inhaled short- or long-acting beta-agonists, inhaled corticosteroids, or short- or long-acting anticholinergics) for 28 weeks during Periods IV and V (EXT2) arm 6: Participants receive usual care (inhaled short- or long-acting beta-agonists, inhaled corticosteroids, or short- or long-acting anticholinergics) for 28 weeks during Periods IV and V (EXT2)

[ 0, 0, 0, 2, 0, 1 ]

5

[ 0, 0, 0, 0, 0 ]

intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None

intervention 1: MK-0873 2.5 mg intervention 2: MK-0873 1.25 mg intervention 3: MK-0873 0.75 mg intervention 4: Placebo to MK-0873 intervention 5: Usual Care

0

null

1

NCT00132730

[ 4 ]

572

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

null

This study will assess the efficacy and safety of subcutaneous (sc) Mircera given as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving sc epoetin. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.

null

Anemia

null

3

arm 1: Eligible participants received RO0503821 (Mircera \[methoxy polyethylene glycol-epoetin beta\]) subcutaneously, once every two weeks for 52 weeks. Participants received a starting dose of RO0503821 60, 100, or 180 microgram (mcg) which was based on the epoetin dose of\<8000, 8000-16000, or \>16000 international units (IU)/week, administered during the week preceding the switch to the study drug. arm 2: Eligible participants received RO0503821 subcutaneously, once every four weeks for 52 weeks. Participants received a starting dose of RO0503821 120, 200, or 360 mcg which was based on the epoetin dose of\<8000, 8000-16000, or \>16000 IU/week administered during the week preceding the switch to the study drug. arm 3: Eligible participants received their ongoing weekly subcutaneous dose of epoetin alfa or beta one, two or three times weekly for 52 weeks .

[ 0, 0, 1 ]

3

[ 0, 0, 0 ]

intervention 1: iv 3 times weekly, as prescribed intervention 2: 60, 100 or 180 micrograms sc (starting dose) every 2 weeks intervention 3: 60, 100 or 180 micrograms sc (starting dose) every 4 weeks

intervention 1: epoetin alfa or beta intervention 2: methoxy polyethylene glycol-epoetin beta (Mircera) intervention 3: methoxy polyethylene glycol-epoetin beta (Mircera)

90

Hot Springs | Arkansas | United States | -93.05518 | 34.5037 Los Angeles | California | United States | -118.24368 | 34.05223 Riverside | California | United States | -117.39616 | 33.95335 Sacramento | California | United States | -121.4944 | 38.58157 San Jose | California | United States | -121.89496 | 37.33939 Boston | Massachusetts | United States | -71.05977 | 42.35843 Springfield | Massachusetts | United States | -72.58981 | 42.10148 Detroit | Michigan | United States | -83.04575 | 42.33143 Brooklyn Center | Minnesota | United States | -93.33273 | 45.07608 Raleigh | North Carolina | United States | -78.63861 | 35.7721 Winston-Salem | North Carolina | United States | -80.24422 | 36.09986 Toledo | Ohio | United States | -83.55521 | 41.66394 Portland | Oregon | United States | -122.67621 | 45.52345 Dallas | Texas | United States | -96.80667 | 32.78306 Houston | Texas | United States | -95.36327 | 29.76328 San Antonio | Texas | United States | -98.49363 | 29.42412 Morgantown | West Virginia | United States | -79.9559 | 39.62953 Brussels | N/A | Belgium | 4.34878 | 50.85045 Edegem | N/A | Belgium | 4.44504 | 51.15662 Ghent | N/A | Belgium | 3.71667 | 51.05 Hasselt | N/A | Belgium | 5.33781 | 50.93106 Curitiba | N/A | Brazil | -49.27306 | -25.42778 São Paulo | N/A | Brazil | -46.63611 | -23.5475 São Paulo | N/A | Brazil | -46.63611 | -23.5475 Brno | N/A | Czechia | 16.60796 | 49.19522 Ostrava | N/A | Czechia | 18.28204 | 49.83465 Pilsen | N/A | Czechia | 13.37759 | 49.74747 Odense | N/A | Denmark | 10.38831 | 55.39594 HUS | N/A | Finland | N/A | N/A Tampere | N/A | Finland | 23.78712 | 61.49911 Turku | N/A | Finland | 22.26869 | 60.45148 Bayonne | N/A | France | -1.473 | 43.49316 Boulogne | N/A | France | -1.3194 | 46.79346 Cabestany | N/A | France | 2.9409 | 42.68141 Caen | N/A | France | -0.35912 | 49.18585 Limoges | N/A | France | 1.24759 | 45.83362 Nîmes | N/A | France | 4.35788 | 43.83665 Pantin | N/A | France | 2.40935 | 48.89437 Poitiers | N/A | France | 0.34348 | 46.58261 Saint-Germain-en-Laye | N/A | France | 2.0904 | 48.89643 Saint-Priest-en-Jarez | N/A | France | 4.37678 | 45.4739 Thionville | N/A | France | 6.16044 | 49.35994 Tours | N/A | France | 0.70398 | 47.39484 Bad Hersfeld | N/A | Germany | 9.70891 | 50.87197 Berlin | N/A | Germany | 13.41053 | 52.52437 Kaiserslautern | N/A | Germany | 7.77161 | 49.443 Budapest | N/A | Hungary | 19.04045 | 47.49835 Budapest | N/A | Hungary | 19.04045 | 47.49835 Debrecen | N/A | Hungary | 21.62444 | 47.53167 Miskolc | N/A | Hungary | 20.77806 | 48.10306 Pécs | N/A | Hungary | 18.23083 | 46.0725 Cremona | N/A | Italy | 10.02129 | 45.13325 Lecco | N/A | Italy | 9.39704 | 45.85589 Mestre | N/A | Italy | 12.24538 | 45.49167 Modena | N/A | Italy | 10.92539 | 44.64783 Prato | N/A | Italy | 11.09699 | 43.8805 Venezia | N/A | Italy | 11.17365 | 44.42329 Cuernavaca | N/A | Mexico | -99.23075 | 18.9261 Mexico City | N/A | Mexico | -99.12766 | 19.42847 Christchurch | N/A | New Zealand | 172.63333 | -43.53333 Wellington | N/A | New Zealand | 174.77557 | -41.28664 Panama City | N/A | Panama | -79.51973 | 8.9936 Gdansk | N/A | Poland | 18.64912 | 54.35227 Kielce | N/A | Poland | 20.62752 | 50.87033 Krakow | N/A | Poland | 19.93658 | 50.06143 Wroclaw | N/A | Poland | 17.03333 | 51.1 Ponce | N/A | Puerto Rico | -66.62398 | 18.01031 Durban | N/A | South Africa | 31.0292 | -29.8579 Alcorcón | N/A | Spain | -3.82487 | 40.34582 Barcelona | N/A | Spain | 2.15899 | 41.38879 Madrid | N/A | Spain | -3.70256 | 40.4165 Madrid | N/A | Spain | -3.70256 | 40.4165 Palma de Mallorca | N/A | Spain | 2.65024 | 39.56939 Pamplona | N/A | Spain | -1.64323 | 42.81687 Santiago de Compostela | N/A | Spain | -8.54569 | 42.88052 Huddinge | N/A | Sweden | 17.98192 | 59.23705 Karlstad | N/A | Sweden | 13.50357 | 59.3793 Taichung | N/A | Taiwan | 120.6839 | 24.1469 Taipei | N/A | Taiwan | 121.52639 | 25.05306 Bangkok | N/A | Thailand | 100.50144 | 13.75398 Bangkok | N/A | Thailand | 100.50144 | 13.75398 Phitsanulok | N/A | Thailand | 100.25858 | 16.82481 Belfast | N/A | United Kingdom | -5.92541 | 54.59682 Cambridge | N/A | United Kingdom | 0.11667 | 52.2 Dundee | N/A | United Kingdom | -2.97489 | 56.46913 Exeter | N/A | United Kingdom | -3.52751 | 50.7236 Leicester | N/A | United Kingdom | -1.13169 | 52.6386 London | N/A | United Kingdom | -0.12574 | 51.50853 London | N/A | United Kingdom | -0.12574 | 51.50853 London | N/A | United Kingdom | -0.12574 | 51.50853

1

NCT00077623

[ 4 ]

80

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

true

0ALL

true

Patients undergoing keyhole gall bladder removal will be divided into 3 groups, one control, one will have local anaesthetic and the third will have normal saline nebulised into their abdomen before closure of the wounds to reduce postoperative pain. These medications will be given on top of the standard pain management protocol.

Pain post laparoscopic procedures can be divided into access related, operation site and distension related. The access type can be attenuated by the use of sub dermal infiltration of local anaesthetic and rarely causes significant discomfort. It has been advocated that placement of a peritoneal gas drain significantly reduces postoperative pain particularly referred to the shoulder tip. Realistically, however, if attention is paid to expelling the residual gas at the end of the procedure this complication is rarely problematic. Operative site pain however is more difficult to manage. In limited gynaecological procedures it has been shown that local installation of local anaesthetic decreased the analgesic requirement of patients post operatively. These observations would not be as transferable to more extensive colorectal or solid organ surgery as the amount of local anaesthesia required would be toxic to the patient. Use of the nebuliser, however maybe able to alleviate pain by efficiently using the dosage required. This is a prospective randomised double blind trial. Sixty patients will be allocated randomly between three groups, 20 patients in each group: 1. Control group 2. Nebulised intraperitoneal local anaesthetic (Bupivacaine 0.25%, 3mg/Kg) 3. Nebulised intraperitoneal normal saline Ward staff will be blinded to which group the patients are in. All patients undergoing laparoscopic cholecystectomy who have given written, informed consent are eligible for inclusion. Patients with local anaesthetics allergy and patients whom pain evaluation is considered unreliable due to chronic opiate use or neurological diseases are excluded. No pre-medication is to be given and a standardised anaesthetic technique is to be employed for all patients. Standard 4 ports technique for laparoscopic cholecystectomy will be used with intraperitoneal pressure between 12-14 mmHg. This will be achieved using CO2 as the insufflation gas. The local anaesthetic (approximately 10mls) will be delivered via a fine sterile catheter that will be inserted via the epigastric port under direct vision at the end of the procedure. Afterward the pneumoperitoneum will be deflated and the wound will be closed and subcutaneous local anaesthetic will be injected in and around the wounds. Postoperatively, all the patients will have PCA as the main analgesia supported by NSAIDs unless contraindicated. Patients will eat and drink as desired and drips will be taken as soon as it is safe to do so. Postoperative pain scoring will be stared in recovery and continue on the wards using the visual analogue scale.

Pain, Postoperative

Pain Nebulisation Cholecystectomy Laparoscopic Bupivacaine Local Anaesthetic

null

4

arm 1: No intraperitoneal therapeutics (No nebulised Bupivacaine) arm 2: Intraperitoneal nebulised 10mls. Normal Saline (No nebulised Bupivacaine) arm 3: Intraperitoneal Nebulised 10mls. Bupivacaione (Marcaine) arm 4: Intraperitoeal Injected 10 mls.Bupivacaine (Marcaine) (No nebulised Bupivacaine)

[ 3, 2, 0, 1 ]

4

[ 0, 0, 0, 10 ]

intervention 1: Nebulised Marcaine (Bupivacaine) intervention 2: Nebulised Normal Saline intervention 3: Injected Marcaine directly into the peritoneal cavity intervention 4: No Intraperitoneal Therapeutics given

intervention 1: Nebulised Bupivacaine intraperitoneally intervention 2: Normal Saline intervention 3: Injected Bupivacaine intraperitoneally intervention 4: No Intraperitoneal Therapeutics

1

London | N/A | United Kingdom | -0.12574 | 51.50853

0

NCT00180687

[ 0 ]

31

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

null

The study drug levetiracetam is FDA approved as an add-on medication in the treatment of partial onset seizures in adults with epilepsy. The trade name is Keppra®. This is an "open-label" trial, which means that all participating patients will receive active study drug. The Jefferson Headache Center has developed this clinical study to evaluate the safety and effectiveness of levetiracetam in preventing migraine headaches, with or without aura (visual disturbances). In addition, the study site will be performing a procedure called Transcranial Magnetic Stimulation (TMS). This procedure measures brain activity because it is thought that people with migraine experience periods of cortical hyperexcitability or over-activity in the brain. This information may help physicians in the future determine which preventive medications will work for which patients.

null

Migraine

null

1

arm 1: Subject titrated open-label study drug to maximally tolerated dose: maximum: 3000 mg. per date. (minimum allowed daily dose to remain in study: 1000)

[ 0 ]

2

[ 0, 3 ]

intervention 1: Daily dose of open label levatiracetam was 3000 mg. or maximally tolerated dose. (Maximum daily dose: 3000 mg. Minimum daily dose allowed for study participation:1000 mg) intervention 2: None

intervention 1: levetiracetam intervention 2: Transcranial Magnetic Stimulation

1

Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238

0

NCT00203216

[ 5 ]

28

RANDOMIZED

PARALLEL

null

4QUADRUPLE

null

0ALL

null

The purpose of this study is to determine if lamotrigine therapy is associated with improvement in mood, memory and hippocampal size and function in patients receiving chronic corticosteroid therapy. Standard care for mood changes associated with corticosteroid therapy, if severe, includes antidepressants or other medications which can influence mood. No therapies, other than dose reduction or discontinuation, are currently available for memory loss associated with corticosteroid treatment. However, very little information is available on the treatment of either mood or memory changes associated with corticosteroid treatment, thus the proposed project may improve standard care.

null

Memory Impairment Due to Corticosteroid Use Hypomania Due to Corticosteroid Use Hippocampal Atrophy Due to Corticosteroid

null

0

null

1

[ 0 ]

intervention 1: None

intervention 1: Lamotrigine (Drug)

1

Dallas | Texas | United States | -96.80667 | 32.78306

0

NCT00223262

[ 4 ]

660

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

false

The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (BTDS) 20 in comparison to the buprenorphine transdermal system (BTDS) 5 and oxycodone immediate-release in subjects with moderate to severe low back pain currently treated with oral opioids. The double-blind treatment intervention duration is 12 weeks during which time supplemental analgesic medication (acetaminophen, ibuprofen) will be provided to all subjects in addition to study drug.

Buprenorphine is a synthetic opioid analgesic with over 25 years of international clinical experience indicating it to be safe and effective in a variety of therapeutic situations for the relief of moderate to severe pain.

Back Pain Lower Back Chronic

Low back pain opioid transdermal Butrans

null

3

arm 1: Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear. arm 2: Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear. arm 3: Oxycodone immediate-release 40 mg (two 5-mg capsules every 6 hours).

[ 1, 0, 0 ]

3

[ 0, 0, 0 ]

intervention 1: Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear. intervention 2: Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear intervention 3: Oxycodone HCl immediate-release 40 mg (two 5-mg capsules every 6 hours).

intervention 1: Buprenorphine intervention 2: Buprenorphine intervention 3: Oxycodone Immediate-Release

85

0

NCT00313014

[ 3, 4 ]

628

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

To evaluate the safety and efficacy of SLIT compared with placebo for reduction of symptoms and rescue medication usage

null

Allergy

Sublingual immunotherapy Grass pollen tablet Allergic rhinoconjunctivitis

null

4

arm 1: 100 IR grass pollen allergen extract tablet arm 2: 300 IR grass pollen allergen extract tablet arm 3: 500 IR grass pollen allergen extract tablet arm 4: Placebo tablet

[ 0, 0, 0, 2 ]

4

[ 0, 0, 0, 0 ]

intervention 1: One sublingual tablet daily during 4 months before pollen season and during pollen season intervention 2: One sublingual tablet daily during 4 months before pollen season and during pollen season intervention 3: One sublingual tablet daily during 4 months before pollen season and during pollen season intervention 4: One sublingual tablet daily during 4 months before pollen season and during pollen season

intervention 1: 100 IR grass pollen allergen extract tablet intervention 2: 300 IR grass pollen allergen extract tablet intervention 3: 500 IR grass pollen allergen extract tablet intervention 4: Placebo tablet

0

null

0

NCT00367640

[ 3 ]

17

NON_RANDOMIZED

PARALLEL

1PREVENTION

0NONE

false

0ALL

false

To evaluate the feasibility, safety and tolerability of aerosolized lucinactant delivered by nasal continuous positive airway pressure (nCPAP) for the prevention of respiratory distress syndrome (RDS) in premature infants.

Use of a device in the early treatment of RDS that permits the effective aerosolization of an exogenous surfactant that also allows for the simultaneous delivery of continuous positive airway pressure would permit the delivery of surfactant to the distal airways without intubation. This approach could reduce the frequency of severity of the adverse events relative to endotracheal intubation and surfactant administration via bolus.

Respiratory Distress Syndrome

Lucinactant Nasal continuous positive airway pressure (nCPAP) Respiratory distress syndrome (RDS) Pediatric Premature

null

2

arm 1: None arm 2: None

[ 0, 0 ]

2

[ 0, 0 ]

intervention 1: Aerosolized lucinactant via nCPAP over 3 hours. Up to 3 retreatments will be allowed over a 48 hour period with each retreatment separated by at least 3 hours. intervention 2: Aerosolized lucinactant via nCPAP over 3 hours. Up to 3 retreatments will be allowed over a 48 hour period with each retreatment separated by at least 1 hour.

intervention 1: Aerosolized lucinactant intervention 2: Aerosolized lucinactant

1

San Diego | California | United States | -117.16472 | 32.71571

0

NCT00807235

[ 4 ]

55

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

1FEMALE

null

In-vitro fertilization (IVF) of human oocytes followed by the replacement of embryo in the uterine cavity has become a well established treatment for female infertility attributable to damaged fallopian tubes, endometriosis or unexplained causes where alternative forms of therapy have failed. The most commonly used protocols of follicular stimulation now employs follicle stimulating hormone (FSH) and long-acting agonists of gonadotropin releasing hormone (GnRH) to prevent the occurrence of a mid-cycle luteinizing hormone (LH) surge and to ensure the induction of well-synchronized larger cohort of ovarian follicles. The results of a number of studies have demonstrated that in the majority of clinical situations, FSH administration alone is sufficient to achieve successful follicular development. A study had shown that in subjects receiving recombinant human-follicle stimulating hormone (r-hFSH) and recombinant human-luteinizing hormone (r-hLH), pregnancy rates were similar in the younger and older age groups, however, in women receiving r-hFSH alone, there was a significant decline in pregnancy rates for women 35 and older. This particular study also went on to show that the subgroup of women 35 and older, may benefit from supplementary r-hLH. A number of studies have been conducted to assess the safety and efficacy of r-hLH administered concomitantly with r-hFSH in the presence of developing follicles to reduce the rate of growth of intermediate and small follicles while allowing the dominant follicle to continue to progress. This was a Phase III, open-label, multicentre study to evaluate safety and efficacy of addition of Recombinant Human-Luteinizing Hormone (Luveris) to a standard assisted reproductive technologies (ART) protocol.

Luteinizing hormone is a heterodimeric glycoprotein composed of a non-covalent association of an α and a β subunit. Prior to the generation of human-LH (hLH) through recombinant technology, hLH had only been available for therapeutic use as human menopausal gonadotropins (hMG), a co-extracted, purified preparation of hLH and hFSH from urine of post menopausal women. Recombinant Human-Luteinizing Hormone (Luveris) has been found to be well tolerated in human pharmacokinetic and pharmacodynamic studies at doses of up to 40,000 IU in healthy female volunteers without any Serious Adverse Event (SAE) experience being reported. OBJECTIVES * To evaluate safety and efficacy of addition of Recombinant Human-Luteinizing Hormone (Luveris) to a standard ART procedure. In this study, subjects were first treated with a GnRH agonist to induce pituitary desensitization according to centre's standard practice followed by administration of r-hFSH. All subjects were then treated with Recombinant Human -Luteinizing Hormone (Luveris)150 IU per day subcutaneous (s.c.) from Day 6 of stimulation of their ART treatment cycle, continuing at the same dose until injection of hCG upto and including day of last FSH dose.

Infertility Ovarian Stimulation

Infertility Ovarian Stimulation Luveris Lutropin alpha Controlled ovarian stimulation Reproductive techniques, assisted

null

0

null

1

[ 0 ]

intervention 1: Recombinant Human-Luteinizing Hormone (Luveris) was administered once daily subcutaneously at a starting dose of 150 IU per day beginning on stimulation Day 6.

intervention 1: Recombinant Human-Luteinizing Hormone (Luveris)

0

null

0

NCT01121991

[ 2 ]

22

RANDOMIZED

CROSSOVER

null

0NONE

true

1FEMALE

false

The objective of this study is to evaluate the comparative bioavailability between Anastrozole 1 mg Tablets (Teva Pharmaceuticals USA) and Arimidex® 1 mg Tablets (AstraZeneca Pharmaceuticals LP, USA), after a single-dose in healthy subjects under fasting conditions.

Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA Bioequivalence Statistical Methods

Healthy

Healthy Subjects Bioequivalence

null

2

arm 1: Anastrozole Tablets, 1 mg arm 2: Arimidex® Tablets, 1 mg

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: 1 mg Tablets intervention 2: 1 mg Tablets

intervention 1: Anastrozole (Teva Pharmaceuticals USA) intervention 2: Anastrozole (Arimidex®)

1

Toronto | Ontario | Canada | -79.39864 | 43.70643

0

NCT01182181

[ 3 ]

68

NON_RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

2MALE

null

This study will evaluate the efficacy and safety of intravenous (IV) pertuzumab in participants with hormone-refractory prostate cancer who have had no previous chemotherapy. Participants will be enrolled in two stages, the first (Cohort A) at a lower 420-mg dose and the second (Cohort B) at a higher 1050-mg dose based upon observations in Cohort A. Up to 50 participants may enter either cohort, for a total enrollment between 46 and 73 participants across 9 study centers.

null

Prostate Cancer

null

2

arm 1: Participants in Cohort B will receive 1050 mg pertuzumab via IV infusion on Day 1 of each 3-week cycle. At the end of 3 treatment cycles, response will be evaluated to determine whether additional participants will be enrolled for treatment. If a second stage of enrollment occurs, participants may continue treatment until disease progression or unacceptable toxicity. arm 2: Participants in Cohort A will receive an IV loading dose of 840 milligrams (mg) pertuzumab followed by 420 mg via IV infusion on Day 1 of each 3-week cycle. At the end of 3 treatment cycles, response will be evaluated to determine whether additional participants will be enrolled for treatment. If a second stage of enrollment occurs, participants may continue treatment until disease progression or unacceptable toxicity.

[ 0, 0 ]

1

[ 0 ]

intervention 1: Participants will receive pertuzumab on Day 1 of each 3-week cycle. In Cohort A, an 840-mg loading dose will be administered prior to the 420-mg IV infusion. In Cohort B, the 1050-mg IV infusion will be administered with no loading dose.

intervention 1: Pertuzumab

11

Lyon | N/A | France | 4.84671 | 45.74846 Montpellier | N/A | France | 3.87635 | 43.61093 Berlin | N/A | Germany | 13.41053 | 52.52437 Parma | N/A | Italy | 10.32618 | 44.79935 Roma | N/A | Italy | 11.10642 | 44.99364 Rotterdam | N/A | Netherlands | 4.47917 | 51.9225 Barcelona | N/A | Spain | 2.15899 | 41.38879 Valencia | N/A | Spain | -0.37966 | 39.47391 Cardiff | N/A | United Kingdom | -3.18 | 51.48 Sutton | N/A | United Kingdom | -0.2 | 51.35 Weston-super-Mare | N/A | United Kingdom | -2.97665 | 51.34603

0

NCT02480010

[ 2 ]

19

NON_RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

null

This study will evaluate the safety, tolerability, and pharmacokinetics of the combination of rhuMab 2C4(Perjeta) and capecitabine (Xeloda) in participants with advanced solid tumors that have progressed during or after standard therapy, or for which no standard therapy is available. Participants will be enrolled and evaluated for dose-limiting toxicities (DLTs) in escalating-dose cohorts in order to determine the maximum tolerated dose (MTD).

null

Solid Tumor

null

3

arm 1: Participants will receive a single 1000-mg/m\^2 dose of oral (PO) capecitabine on Day -7 for pretreatment assessment. Capecitabine will then be administered on Days 1 to 14 of each 3-week cycle at a dose of 1000 mg/m\^2 twice daily, and rhuMab 2C4 will be given on Day 1 of each 3-week cycle as a fixed-dose 1050-mg IV infusion. The incidence of DLTs will be used to guide intrapatient dose modification, as well as subsequent enrollment. arm 2: Participants will receive a single 1250-mg/m\^2 dose of PO capecitabine on Day -7 for pretreatment assessment. Capecitabine will then be administered on Days 1 to 14 of each 3-week cycle at a dose of 1250 mg/m\^2 twice daily, and rhuMab 2C4 will be given on Day 1 of each 3-week cycle as a fixed-dose 1050-mg IV infusion. The incidence of DLTs will be used to guide intrapatient dose modification, as well as subsequent enrollment. arm 3: Participants will receive a single 825-mg/m\^2 dose of PO capecitabine on Day -7 for pretreatment assessment. Capecitabine will then be administered on Days 1 to 14 of each 3-week cycle at a dose of 825 mg/m\^2 twice daily, and rhuMab 2C4 will be given on Day 1 of each 3-week cycle as a fixed-dose 1050-mg IV infusion. The incidence of DLTs will be used to guide intrapatient dose modification, as well as subsequent enrollment.

[ 0, 0, 0 ]

2

[ 0, 0 ]

intervention 1: Participants will receive capecitabine on Days 1 to 14 of each 3-week cycle as 825, 1000, or 1250 mg/m\^2 PO twice daily. Treatment may continue until disease progression, unacceptable toxicity, or consent withdrawal. intervention 2: Participants will receive rhuMab 2C4 on Day 1 of each 3-week cycle as 1050 mg via IV infusion. Treatment may continue until disease progression, unacceptable toxicity, or consent withdrawal.

intervention 1: Capecitabine intervention 2: RhuMab 2C4

2

Barcelona | N/A | Spain | 2.15899 | 41.38879 Manchester | N/A | United Kingdom | -2.23743 | 53.48095

0

NCT02494596

[ 5 ]

301

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

null

To examine the efficacy of continued administration of rebamipide following bacteria eradication therapy in patients with H. pylori-positive active gastric ulcer in a placebo-controlled, double-blind study

null

Stomach Ulcer

null

0

null

1

[ 0 ]

intervention 1: None

intervention 1: Rebamipide

1

Tokyo | N/A | Japan | 139.69171 | 35.6895

0

NCT00233389

[ 4 ]

326

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

null

The primary objective of the study is to determine if Serostim® 4 mg administered daily for 12 weeks as treatment for the abnormal fat accumulation and distribution associated with HIV-associated Adipose Redistribution Syndrome (HARS) reduces Visceral Adipose Tissue (VAT, measured by CT scan) more effectively than placebo.

null

HIV Infections Lipodystrophy

Growth hormone Serostim® Human Adipose Redistribution Syndrome Human Immunodeficiency Virus lipodystrophy

null

5

arm 1: Subjects will receive placebo matched to serostim® as subcutaneous injection daily for a period of 12 weeks. arm 2: Subjects will receive Serostim® as subcutaneous injection at a maximum dose of 4 milligram (mg) per day based on body weight for a period of 12 weeks. arm 3: All subjects who will be initially randomized to Serostim® 4 mg arm in Period I and will receive placebo matched to Serostim® on alternate days for 24 weeks in Period II. arm 4: All subjects who will be initially randomized to Serostim® 4 mg arm in Period I and will receive Serostim® 2 mg on alternate days for 24 weeks in Period II. arm 5: All subjects who will be initially randomized to Placebo arm in Period I continue receiving placebo matched to Serostim® on alternate days for 12 weeks followed by Serostim® 4 mg daily 12 weeks.

[ 2, 0, 0, 0, 0 ]

3

[ 0, 0, 0 ]

intervention 1: Placebo matched to serostim® as subcutaneous injection. intervention 2: Serostim® as subcutaneous injection at a maximum dose of 4 milligram (mg) per day based on body weight. intervention 3: Serostim® 2 mg as subcutaneous injection on alternate days.

intervention 1: Placebo intervention 2: Serostim® 4 mg intervention 3: Serostim® 2 mg

31

0

NCT00082628

[ 3 ]

265

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

The purpose of this study is to determine the safety and efficacy of alogliptin, once daily (QD), compared to diet and exercise, sulfonylurea, metformin and a combination of sulfonylurea and metformin for treating subjects with type 2 diabetes.

Of the approximately 19 million people in the United States who have been diagnosed with diabetes mellitus, 90% to 95% have type 2 diabetes mellitus. The prevalence of type 2 diabetes mellitus varies among racial and ethnic populations and has been shown to increase with age, obesity, family history, history of gestational diabetes, and physical inactivity. Over the next decade, a disproportionate increase in the elderly population will result in a marked increase in diabetic patients, placing an ever-increasing burden on families and the health care system. In response to this problem, Takeda Global Research \& Development Center, Inc. is developing SYR-322 (alogliptin), a selective, orally available inhibitor of the enzyme dipeptidyl peptidase IV. Dipeptidyl peptidase IV is thought to be primarily responsible for the in vivo degradation of 2 peptide hormones released in response to nutrient ingestion, namely glucagon-like peptide-1 and glucose-dependent insulinotropic peptide. Individuals who want to participate in this study will be required to provide written informed consent. Study participation is anticipated to be about 14 Weeks. Multiple procedures will occur at each visit which may include blood collection, urine collection, vital signs including sitting and standing blood pressure and pulse, body height and weight, physical examinations and electrocardiograms.

Diabetes Mellitus

Diabetes Mellitus Drug Therapy Diabetes Mellitus, Type II Type 2 Diabetes Mellitus Hyperinsulinism Insulin Resistance

null

6

arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None

[ 0, 0, 0, 0, 0, 2 ]

6

[ 0, 0, 0, 0, 0, 0 ]

intervention 1: Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks intervention 2: Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks. intervention 3: Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks. intervention 4: Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks. intervention 5: Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks. intervention 6: Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.

intervention 1: Alogliptin intervention 2: Alogliptin intervention 3: Alogliptin intervention 4: Alogliptin intervention 5: Alogliptin intervention 6: Placebo

0

null

1

NCT00755846

[ 3 ]

22

null

0TREATMENT

null

false

2MALE

null

The primary purpose of this study is to determine the safest dose of ZD4054 (Zibotentan)in men with prostate cancer

null

Prostatic Neoplasms Metastases, Neoplasm

prostate cancer Metastatic prostate cancer bone metastases

null

3

arm 1: 1 x 10 mg oral tablets once daily arm 2: 1 x 10 mg + 2 x 2.5 mg oral tablets once daily arm 3: 2 x 10 mg + 1 x 2.5 mg oral tablets once daily

[ 0, 0, 0 ]

3

[ 0, 0, 0 ]

intervention 1: 1 x 10 mg oral tablets once daily intervention 2: 1 x 10 mg + 2 x 2.5 mg oral tablets once daily intervention 3: 2 x 10 mg + 2 x 2.5 mg oral tablets once daily

intervention 1: ZD4054 10 mg intervention 2: ZD4054 15 mg intervention 3: ZD4054 22.5 mg

2

0

NCT00055471

[ 3 ]

61

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

A 1-year outpatient study to test the safety and tolerability of a new medication in the treatment of schizophrenia

Study will evaluate long-term safety and tolerability of a new compound in the treatment of patients with schizophrenia as assessed by adverse events (AEs), measures of extra pyramidal symptoms (EPS; Abnormal Involuntary Movement Scale \[AIMS\], Barnes Akathisia Scale \[BAS\], and Simpson-Angus Rating Scale \[SAS\]), vital sign measurements, electrocardiograms (ECGs), clinical laboratory evaluations.

Schizophrenia

Schizophrenia Latuda Lurasidone

null

1

arm 1: Lurasidone 80mg oral tablet taken once a day

[ 0 ]

1

[ 0 ]

intervention 1: None

intervention 1: Lurasidone 80mg tablet

21

0

NCT00088621

[ 4 ]

743

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

false

The purpose of this study is to evaluate the clinical and microbial efficacy and safety of AzaSite compared to tobramycin for bacterial conjunctivitis. Adults and children one year of age and older with bacterial conjunctivitis in at least one eye are eligible. Subjects will be randomly assigned to the AzaSite group or Tobramycin group. Three visits will be required for the study.

null

Bacterial Conjunctivitis

Bacterial Conjunctivitis Pink Eye Conjunctivitis Eye Infection

null

2

arm 1: 1.0% azithromycin in DuraSite arm 2: 0.3% tobramycin

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: AzaSite ophthalmic solution; one topical drop to the infected eye or eyes twice daily (in the morning and at bedtime) on Days 1 and 2 followed by once daily (in the morning between 7 and 10am) on Days 3 through 5. intervention 2: Tobramycin ophthalmic solution; one topical drop to the infected eye or eyes four times daily at 4 to 6 hour intervals (first dose in the morning between 7 and 10am) for 5 days.

intervention 1: AzaSite intervention 2: Tobramycin

26

0

NCT00105469

[ 4 ]

288

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

null

To investigate the efficacy and safety of a 4-week treatment of 5 mg/day or 10 mg/day of E3810 (Pariet (Rabeprazole Sodium)) in patients with non-erosive gastroesophageal reflux disease in a multicenter, randomized, double-blind, comparative study.

null

Non-erosive Gastroesophageal Reflux Disease

non-erosive gastroesophageal reflux disease NERD proton pump inhibitor rabeprazole

null

3

arm 1: None arm 2: None arm 3: None

[ 0, 0, 2 ]

3

[ 0, 0, 0 ]

intervention 1: E3810 5mg: once daily orally for 4 weeks intervention 2: E3810 10mg: once daily orally for 4 weeks intervention 3: Placebo: once daily orally for 4 weeks

intervention 1: E3810 intervention 2: E3810 intervention 3: Placebo

35

0

NCT00165646

[ 4 ]

26

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

null

To investigate esophageal reflux condition in patients with non-erosive gastroesophageal reflux disease by assessing with a 24-hour esophageal pH monitoring or effects of a 4-week treatment with 5 mg/day or 10 mg/day of E3810 (Pariet (Rabeprazole Sodium)).

null

Non-erosive Gastroesophageal Reflux Disease

24-hour esophageal pH monitoring non-erosive gastroesophageal reflux disease NERD proton pump inhibitor rabeprazole

null

2

arm 1: None arm 2: None

[ 0, 0 ]

2

[ 0, 0 ]

intervention 1: rabeprazole sodium 5 mg: once daily orally for 4 weeks intervention 2: rabeprazole sodium 10 mg: once daily orally for 4 weeks

intervention 1: RABEPRAZOLE SODIUM intervention 2: RABEPRAZOLE SODIUM

13

0

NCT00165672

[ 4 ]

451

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

true

The purpose of this study is to determine which dose of voclosporin is effective in the treatment of plaque psoriasis compared to placebo.

Psoriasis is a chronic skin condition that can have a significant impact on patient's physical and mental well being. The most common form of psoriasis is plaque psoriasis. Targeted treatments in psoriasis have been reported recently, yet cyclosporine, a calcineurin inhibitor (CNi) remains one of the treatments which has the greatest efficacy. Voclosporin represents the possibility of a calcineurin inhibitor which is not only as efficacious as cyclosporine A, but also has an improved toxicity profile. Comparison(s): Voclosporin at 3 dose levels (0.2, 0.3, and 0.4 mg/kg twice a day)compared to placebo.

Psoriasis

Randomized Controlled Trials Immunosuppression Adult Chronic Disease Dermatologic Agents Female Humans Male Middle Aged Severity of Illness Index Treatment Outcome Quality of Life Double-Blind Method

null

4

arm 1: Placebo arm 2: Voclosporin 0.2 mg/kg po BID arm 3: Voclosporin 0.3 mg/kg po BID arm 4: Voclosporin 0.4 mg/kg po BID

[ 2, 1, 1, 1 ]

2

[ 0, 0 ]

intervention 1: voclosporin 0.2, 0.3, or 0.4 mg/kg po BID intervention 2: Placebo

intervention 1: voclosporin intervention 2: Placebo

31

0

NCT00244842

[ 3 ]

64

RANDOMIZED

CROSSOVER

null

3TRIPLE

false

0ALL

false

Despite preclinical evidence supporting the role of the endogenous opioid system in the reinforcing effects of nicotine, the efficacy of the opioid antagonist naltrexone (NTX) as a tobacco dependence treatment remains unresolved. Research is needed to identify those smokers for whom NTX will have the strongest beneficial effects on smoking behavior. The research bridges existing knowledge of genetic, pharmacologic, and behavioral responses to nicotine, and translates this knowledge to treatment for tobacco dependence. The immediate goal was to test whether genetic variation in the mu-opioid receptor gene predicts the effects of naltrexone (NTX) on nicotine reinforcement.

The study was a within-subject double-blind study of the effects of naltrexone versus placebo on the reinforcing value of nicotine, using a validated cigarette choice paradigm. A key question was whether smokers differ in their responses based on the mu opioid receptor gene (OPRM1) Asn40Asp (A118G) variant. Following informed consent, 64 smokers were enrolled in the study. Of these, 60 completed two 4-day study phases interspersed with a 5-7 day washout phase. Baseline statistics are provided for the 64 smokers who enrolled. Each 4-day study phase included a 3-day drug run-up and monitoring phase, then on the 4th day participants came to our Biobehavioral Lab (BBL) where they took their final 50mg of study medication and completed a cigarette choice paradigm. Following a washout phase, the 4-day sequence will be repeated with the alternative study medication. The order of study medication was randomized and counterbalanced between subjects.

Tobacco Dependence

within-subjects, crossover, laboratory study Naltrexone vs. Placebo

null

2

arm 1: All participants took naltrexone during one of the two 4-day study medication periods. Both 4-day study medication periods were randomized and counterbalanced between naltrexone and placebo; all study medication periods were separated by a 5-7 day washout period. Dosing of the naltrexone was the same for all participants: Day 1: 12.5mg, Day 2: 25mg, Days 3 and 4: 50mg. arm 2: All participants took a placebo (sugar pill) during one of the two 4-day study medication periods. Both 4-day study medication periods were randomized and counterbalanced between naltrexone and placebo. Placebo capsules matched the naltrexone in color, weight and inactive ingredients. The only difference the lack of active naltrexone in each capsule.

[ 1, 2 ]

2

[ 0, 0 ]

intervention 1: All participants took naltrexone during one of the two 4-day study medication periods. Both 4-day study medication periods were randomized and counterbalanced between naltrexone and placebo; all study medication periods were separated by a 5-7 day washout period. Dosing of the naltrexone was the same for all participants: Day 1: 12.5mg, Day 2: 25mg, Days 3 and 4: 50mg. intervention 2: All participants took a placebo (sugar pill) during one of the two 4-day study medication periods. Both 4-day study medication periods were randomized and counterbalanced between naltrexone and placebo. Placebo capsules matched the naltrexone in color, weight and inactive ingredients. The only difference the lack of active naltrexone in each capsule.

intervention 1: Naltrexone intervention 2: Placebo

1

Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238

0

NCT00270231

[ 3 ]

75

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

true

0ALL

false

Development of Staccato Prochlorperazine for the treatment of migraine headache.

null

Migraine Headache, With or Without Aura

Migraine, Staccato Prochlorperazine Migraine headache with or without aura.

null

3

arm 1: Inhaled Staccato Placebo arm 2: Inhaled Staccato Prochlorperazine 5 mg arm 3: Inhaled Staccato Prochlorperazine 10 mg

[ 2, 0, 2 ]

3

[ 0, 0, 0 ]

intervention 1: Inhaled Staccato Placebo intervention 2: Inhaled Prochlorperazine 5 mg intervention 3: Inhaled Prochlorperazine10 mg

intervention 1: Staccato Placebo intervention 2: Staccato Prochlorperazine 5 mg intervention 3: Staccato Prochlorperazine 10 mg

1

Mount Vernon | New York | United States | -73.83708 | 40.9126

0

NCT00610428

[ 4 ]

135

RANDOMIZED

PARALLEL

4SUPPORTIVE_CARE

4QUADRUPLE

false

0ALL

false

The purpose of this study is to evaluate the efficacy of Sativex® compared with placebo in reducing the daily number of episodes on incontinence.

This is a ten week, multicentre, double blind, randomised, placebo controlled parallel group study to evaluate the efficacy of Sativex® on urge incontinence associated with neurogenic unstable bladder. Multiple sclerosis patients with incontinence symptoms are screened to determine eligibility and complete a two-week baseline period. They then return for a further eligibility check, randomisation and initial dosing. Subjects titrate and self-medicate with study medication between study visits at weeks two and five. They will also complete efficacy assessments in their diary-books and at visits.

Detrusor Overactivity Multiple Sclerosis

Detrusor overactivity Multiple Sclerosis

null

2

arm 1: Each 100 ul actuation contains 27 mg delta-9-tetrahydrocannabinol (THC) and 25 mg cannabidiol (CBD). A maximum of 48 actuations (130 mg of THC and 120 mg of CBD) was permitted in any 24 hour period. arm 2: Each 100 ul actuation contains the colorants plus excipients. A maximum of 48 actuations was permitted in any 24 hour period.

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: Containing ∆9 tetrahydrocannabinol (THC), 27 mg/ml and cannabidiol (CBD), 25 mg/ml as extract of Cannabis sativa L. Subjects received study medication delivered in 100 µl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three-hour period and 48 actuations (THC 130 mg:CBD 120 mg) in 24 hours intervention 2: containing excipients only. Subjects received study medication delivered in 100 µl actuations from a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three-hour period and 48 actuations in 24 hours.

intervention 1: Sativex® intervention 2: Placebo

1

Nottingham | Notts | United Kingdom | -1.15047 | 52.9536

0

NCT00678795

[ 5 ]

217

RANDOMIZED

CROSSOVER

9OTHER

0NONE

true

0ALL

false

This was a randomized, open-label, 2-way cross-over study, comparing desloratadine RediTab 2.5 mg to a marketed chewable antihistamine oral medication (Zyrtec® 5 mg Chewable Tablet). Subject preference for one product or the other was determined. Acceptability of product attributes (Taste and Feeling in the Mouth) was rated using a "smile" face scale.

null

Allergies

null

2

arm 1: Subjects received a single dose of desloratadine RediTab followed 8-10 minutes later by a single dose of Zyrtec chewable tablet followed thereafter by a statement of preference. arm 2: Subjects received a single dose of Zyrtec chewable tablet followed 8-10 minutes later by a single dose of desloratadine RediTab followed thereafter by a statement of preference.

[ 1, 1 ]

2

[ 0, 0 ]

intervention 1: SCH 34117: desloratadine RediTabs, 1 tablet (2.5 mg), oral administration, single dose, single day intervention 2: Zyrtec® (cetirizine) Chewable Tablets, 1 tablet (5 mg), oral administration, single dose, single day

intervention 1: Desloratadine intervention 2: Zyrtec® (cetirizine)

0

null

0

NCT00779116

[ 5 ]

220

RANDOMIZED

CROSSOVER

9OTHER

0NONE

true

0ALL

false

The primary objective of this study was to determine whether children ages 6-11 years prefer desloratadine RediTabs (2.5 mg) or a marketed competitor (Zyrtec® 5 mg Chewable Tablets). The secondary objectives of this study were to compare acceptance of the two attributes, taste and feeling in the mouth, of desloratadine 2.5 mg RediTabs and Zyrtec® 5 mg Chewable Tablets

null

Allergies

null

2

arm 1: Subjects received a single dose of desloratadine RediTab followed 8-10 minutes later by a single dose of Zyrtec chewable tablet followed thereafter by a statement of preference. arm 2: Subjects received a single dose of Zyrtec chewable tablet followed 8-10 minutes later by a single dose of desloratadine RediTab followed thereafter by a statement of preference.

[ 1, 1 ]

2

[ 0, 0 ]

intervention 1: desloratadine RediTabs, 1 tablet (2.5 mg),oral administration, single day intervention 2: Zyrtec® (cetirizine) Chewable Tablets, 1 tablet (5 mg), oral administration, single day

intervention 1: Desloratadine intervention 2: Zyrtec® (cetirizine)

0

null

0

NCT00780403

[ 2 ]

22

RANDOMIZED

CROSSOVER

null

0NONE

true

1FEMALE

false

The objective of this study is to evaluate the comparative bioavailability between Anastrozole 1 mg Tablets (Teva Pharmaceuticals, USA) and Arimidex® 1 mg Tablets (AstraZeneca Pharmaceuticals LP, USA), after a single-dose in healthy subjects under fed conditions.

Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA Bioequivalence Statistical Methods

Healthy

Bioequivalence Healthy Subjects

null

2

arm 1: Anastrozole 1 mg Tablets arm 2: Arimidex® 1 mg Tablets

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: 1 mg Tablets intervention 2: 1 mg Tablets

intervention 1: Anastrozole intervention 2: Anastrozole

1

Toronto | Ontario | Canada | -79.39864 | 43.70643

0

NCT01183390

[ 3 ]

182

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

null

The purpose of this study is to determine the effects of SPD503 compared to placebo on tasks of sustained attention in children and adolescents aged 6-17 diagnosed with ADHD.

null

Attention Deficit Disorder With Hyperactivity

null

2

arm 1: None arm 2: None

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: None intervention 2: None

intervention 1: SPD503 (Guanfacine HCl) intervention 2: Placebo

0

null

0

NCT00150592

[ 4 ]

83

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

true

0ALL

null

This study will establish the best dose of the drug naltrexone to treat patients with Pathological Gambling Disorder (PGD) and severe urge symptoms.

PGD is a prominent and growing social problem. Unfortunately, there is no established drug treatment for this disorder. Preliminary investigations demonstrate that naltrexone in doses up to 250 mg/day is well tolerated and safe during an 11-week period and may be a viable treatment option for PGD patients with severe urges. The implications of this study extend from PGD to other impulse control disorders, including compulsive shopping, kleptomania, and possibly alcoholism. Participants are randomly assigned to receive either naltrexone or placebo for 16 weeks. The responses of men and women are compared to determine whether efficacy is distributed in a male:female ratio analogous to that of the PGD population in the United States. A Clinical Global Impression and a Gambling Symptom Scale are used to assess participants.

Gambling

Impulse Control Disorders

null

2

arm 1: 17 weeks of double-blind Naltrexone. Subjects were randomized into one of these three conditions (if they weren't randomized to placebo): naltrexone 50mg/day, 100mg/day, 150mg/day. To minimize nausea, treatment for all subjects was initiated at 25mg/day naltrexone for two days, then the dose was increased to 50mg/day. At week 3, subjects were randomly assigned to 50mg/day continued at that dose, while subjects who were randomized to naltrexone 100mg/day or 150mg/day were raised to the higher doses. arm 2: Subjects who were assigned to placebo in the 17 week double-blind phase.

[ 2, 2 ]

2

[ 0, 0 ]

intervention 1: For subjects who were randomly assigned to naltrexone 50mg/day, 100mg/day, or 150mg/day. intervention 2: For subjects who were randomly assigned to placebo.

intervention 1: Naltrexone intervention 2: Placebo

1

Minneapolis | Minnesota | United States | -93.26384 | 44.97997

0

NCT00053677

[ 5 ]

60

RANDOMIZED

CROSSOVER

0TREATMENT

3TRIPLE

false

0ALL

false

To study the effect of Xyrem (9 g), Xyrem (9 g) plus modafinil 200 mg administered the morning prior to Xyrem, positive control (zolpidem 10 mg), and placebo on the frequency and outcome of events of sleep-disordered breathing in patients with obstructive sleep apnea syndrome (OSAS).

This study will be conducted as a randomized, crossover study of the effect of Xyrem (9 g), Xyrem (9 g) plus modafinil 200 mg administered the morning prior to Xyrem, positive control (zolpidem 10 mg), and placebo on the frequency and outcome of events of sleep-disordered breathing in patients with obstructive sleep apnea syndrome (OSAS).

Obstructive Sleep Apnea Syndrome

Sleep-disordered breathing Obstructive sleep apnea syndrome

null

4

arm 1: Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later arm 2: Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later. arm 3: Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment). arm 4: Placebo was given at bedtime and again 2.5 to 4 hours later.

[ 0, 1, 0, 2 ]

4

[ 0, 0, 0, 0 ]

intervention 1: Xyrem (Sodium Oxybate) Oral Solution intervention 2: Zolpidem 10 mg oral tablets intervention 3: Modafinil Oral Tablets intervention 4: Placebo Oral Solution

intervention 1: Xyrem (X) intervention 2: Zolpidem (Z) intervention 3: Modafinil (M) intervention 4: Placebo (P)

2

0

NCT00086281

[ 4 ]

353

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

null

The purpose of this study is to determine the safety and efficacy of an investigational drug in patients with type 2 diabetes mellitus.

null

Diabetes Mellitus, Type 2

null

2

arm 1: Sitagliptin 100 mg arm 2: Placebo

[ 1, 2 ]

4

[ 0, 0, 0, 0 ]

intervention 1: Sitagliptin 100 mg once daily, from Visit 4 through Visit 8. Day 1 through week 24 intervention 2: Placebo (to match Sitagliptin 100 mg) once daily, from Visit 4 through Visit 8. Day 1 through Week 24 intervention 3: Pioglitazone 30 mg or 45 mg once daily, Visit 2 through Visit 8 intervention 4: Metformin rescue for patients meeting pre-specified glycemic criteria. Metformin 500 mg,once daily, Visit 4 through Visit 8

intervention 1: Comparator: Sitagliptin intervention 2: Comparator: Placebo intervention 3: Comparator: Pioglitazone intervention 4: Metformin

0

null

0

NCT00086502

[ 3 ]

106

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

This study will look at whether this new drug is effective in the treatment of rheumatoid arthritis, and at whether it is safe and well-tolerated by participants with the disease.

null

Rheumatoid Arthritis

null

2

arm 1: MK-0873 1.25 mg twice daily for 12 weeks arm 2: Matching placebo to MK-0873 1.25 mg twice daily for 12 weeks

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: MK-0873 1.25 mg twice daily for 12 weeks intervention 2: Matching placebo to MK-0873 1.25 mg twice daily for 12 weeks

intervention 1: MK-0873 intervention 2: Comparator: Placebo

0

null

0

NCT00132769

[ 4 ]

216

RANDOMIZED

PARALLEL

1PREVENTION

2DOUBLE

false

0ALL

false

A new intravenous medication is being tested for the prevention of the nausea and vomiting that occurs after surgery. This new medication is being compared to another intravenous medication that is already available to patients for this indication.

null

Post-Operative Nausea and Vomiting

null

2

arm 1: 40 mg MK0517 IV arm 2: 4 mg ondansetron IV

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: a single administration of 40 mg MK0517 by IV immediately prior to surgery intervention 2: a single administration of 4 mg ondansetron by IV immediately prior to surgery

intervention 1: Comparator: MK0517 intervention 2: Comparator: ondansetron

0

null

0

NCT00231777

[ 2 ]

50

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

true

0ALL

false

The objective of this study was to assess the safety, tolerability and pharmacokinetics of a single inhaled dose of (administered in 1 or 2 puffs) Staccato Loxapine in healthy volunteers.

Safety and pharmacokinetic data obtained from 50 subjects (between the ages of 18 to 55 years) entered into this randomized, placebo-controlled study. To obtain 50 enrolled subjects, screening procedures and inclusion/exclusion criteria were evaluated for 126 subjects during a variable screening period of up to 21 days. Once enrolled, subjects were randomized to either Staccato Loxapine or Staccato placebo. Plasma samples for pharmacokinetic analysis were collected beginning on Day 0, pre-dose and continuing for 24 hr post dose. Blood samples for the PK analysis of loxapine and its metabolites (8-OH loxapine, 7-OH loxapine and amoxapine) were obtained at time 0 (immediately before dosing), at 30 sec, 1, 2, 3, 5, 10, 30, 45 min, 1, 2, 4, 6, 12, 24 hr after dosing. Plasma concentrations of loxapine and metabolites were used to estimate the following PK parameters for loxapine and its metabolites: area under the plasma concentration time curve from time 0 extrapolated to infinity (AUCinf), AUC from time 0 to time tlast, the last quantifiable concentration (AUClast), maximum observed plasma concentration (Cmax), observed time of Cmax (tmax), terminal phase elimination rate constant (ke), apparent terminal elimination half life calculated from ke (T½ ), apparent total body clearance / fraction absorbed calculated from AUCinf and dose (CL/F) (for loxapine and the metabolites where permitted by measurable concentrations). Safety was evaluated by the incidence of adverse events, clinical laboratory testing (blood chemistry, hematology, and urinalysis), physical examination, vital signs, pulse oximetry, postural vital signs, 12-lead electrocardiogram, pulmonary function tests, continuous 12-lead Holter monitoring, sedation assessments, akathisia assessments.

Schizophrenia

Schizophrenia, Staccato Loxapine

null

5

arm 1: Single 0.625 mg dose of inhaled loxapine or Single Placebo dose of inhaled loxapine arm 2: Single 1.25 mg dose of inhaled loxapine or Single Placebo dose of inhaled loxapine arm 3: Single 2.5 mg dose of inhaled loxapine or Single Placebo dose of inhaled loxapine arm 4: Single 5 mg dose of inhaled loxapine or Single Placebo dose of inhaled loxapine arm 5: Single 10 mg dose of inhaled loxapine or Single Placebo dose of inhaled loxapine

[ 0, 0, 0, 0, 0 ]

6

[ 0, 0, 0, 0, 0, 0 ]

intervention 1: Single 0.625 mg (lowest) dose of inhaled loxapine intervention 2: Single 1.25 mg (2nd) dose of inhaled loxapine intervention 3: Single 2.5 mg (3rd) dose of inhaled loxapine intervention 4: Single 5 mg (4th) dose of inhaled loxapine intervention 5: Single 10 mg (5th) dose of inhaled loxapine intervention 6: Single placebo dose of inhaled loxapine

intervention 1: inhaled Loxapine 0.625 mg intervention 2: inhaled Loxapine 1.25 mg intervention 3: inhaled Loxapine 2.5 mg intervention 4: inhaled Loxapine 5 mg intervention 5: inhaled Loxapine 10 mg intervention 6: inhaled Placebo (0 mg)

1

Evansville | Indiana | United States | -87.55585 | 37.97476

0

NCT00444028

[ 3 ]

30

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

true

The primary purpose of this thirteen-week, open-label study is to test the hypothesis that quetiapine in combination with Oros methylphenidate will reduce aggressive symptoms in children and adolescents who have shown inadequate response to OROS methylphenidate alone.

Informed consent will be obtained from the subject and parent or legal guardian before any study procedures begin. Study procedures will include the verification of inclusion and exclusion criteria, and completion of assessments and safety measures (physical examination, vital signs, adverse events and concomitant medication review, AIMS, laboratory tests, ECG, pregnancy test) as indicated in the Schedule of Events. All laboratory and electrocardiogram results must be reviewed by a physician before the subject returns for Visit 2. Study Period II (Visits 2-5) All subjects meeting entry criteria will initially receive Oros methylphenidate beginning at Visit 2. The Oros methylphenidate will be titrated over 3 visits according to the following schedule: * Visit 2 dose of 18 mg QAM * Visit 3 dose of 36mg QAM * Visit 4 dose of 54mg QAM. * At Visit 5, any subjects unable to tolerate continuation of the Oros methylphenidate dose of 54mg QAM or subjects that meet improvement criteria as defined above will be discontinued from the study. Subjects able to tolerate the daily dose of 54mg Oros methylphenidate and who do not meet improvement criteria at Visit 5 will begin receiving quetiapine in addition to continuing Oros methylphenidate at 54mg QAM for the balance of the study. The initial dose of quetiapine dispensed at Visit 5 will be 25mg QAM for one day with an increase to 25mg BID until Visit 6. At each visit safety and efficacy information will be completed according to the Schedule of Events. Study Period III (Visits 6-10) Quetiapine will be titrated at Visits 6 - 9 according to the parameters in the quetiapine dosing schedule and the completion of safety and efficacy measures listed in the Schedule of Events. A telephone follow-up with the parent or legal guardian will be made 7-9 days after Visit 8 for physician review of subject adverse events and safety. At visit 10 subjects will be given clinical recommendations for follow-up care from a physician investigator after completion of all study procedures (labs/EKG, vital signs, physical exam, AIMS, ADHD-RS-IV, CGI-I, CGI-S, RAAPP, MOAS, SNAP, CCPT)

Attention Deficit Disorder With Hyperactivity

ADHD-Combined TypeDisruptive behavior Disorder

null

1

arm 1: Oros Methylphenidate and Quetiapine

[ 0 ]

2

[ 0, 0 ]

intervention 1: Oros methylphenidate will be titrated over 3 visits according to the following schedule: * Visit 2 dose of 18 mg QAM * Visit 3 dose of 36mg QAM * Visit 4 dose of 54mg QAM. intervention 2: Quetiapine will be titrated according to the following schedule as determined by efficacy and safety assessments (See Table 1). Table 1: Quetiapine Dosing Schedule (subject's required weight = 30-80 kg) * Visit 5 dose of 25mg BID * Visit 6 dose of 50mg BID * Visit 7 dose of 100mg BID * Visit 8 dose of 200mg BID * Visit 9 dose of 300mg BID Efficacy: For any visit following Visit 5, dosage will remain stable if clinically significant improvement criteria are met.If subjects subsequently fail to meet clinically significant improvement criteria, dose increases will resume at the next level of the dosing schedule.

intervention 1: Oros Methylphenidate intervention 2: quetiapine

1

Indianapolis | Indiana | United States | -86.15804 | 39.76838

0

NCT00550147

[ 3 ]

92

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

false

This study is to determine the effectiveness and safety of WR 279,396, a topical cream for the treatment of cutaneous leishmaniasis. This study is to be conducted with a placebo control under double-blind conditions in a local population group in Tunisia where leishmaniasis is endemic.

WR 279,396 is a paromomycin-based topical cream that has shown some suggestion of being effective for the treatment of non-serious, non-complicated cutaneous leishmaniasis in previous clinical studies. The goal of this study is to expand those observations in a larger, more rigorous study to clearly define the efficacy of this product and collect information about adverse effects. Subjects will be randomized to receive either WR 279,396 or vehicle placebo; applied twice a day for 20 days.

Cutaneous Leishmaniasis

cutaneous leishmaniasis topical treatment safety efficacy

null

2

arm 1: WR 279,396 is a topical antibiotic cream containing paromomycin and gentamicin arm 2: Topical cream vehicle containing all of the components in WR 279,396 except the active ingredients.

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: A topical cream containing 15% paromomycin and 0.5% gentamicin. Approximately 0.0005 mL per mm2 of skin lesion intervention 2: Topical cream vehicle. Approximately 0.0005 mL per mm2 of skin lesion

intervention 1: WR 279,396 intervention 2: Placebo

2

Paris | N/A | France | 2.3488 | 48.85341 Tunis | N/A | Tunisia | 10.16579 | 36.81897

0

NCT00703924

[ 3 ]

21

NON_RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

Non-randomized open label Phase II clinical trial in which subjects meeting criteria for RLS were assigned to 1 of 3 treatment cohorts. The first cohort received one 500 mg IV iron sucrose infusion in 500 mL normal sterile saline (NSS) administered over four hours. The second cohort received two 500 mg IV iron sucrose infusions in 500mL of NSS administered over four to six hours on two separate dates, separated by two to seven days. The third cohort received two 500 mg IV iron sucrose infusions in at least 500 mL of NSS over six hours within 30 hours of the start of the first infusion. Cohorts were enrolled and treated subsequently.

null

Restless Legs Syndrome

null

3

arm 1: 500 mg dose Venofer over 4 hours arm 2: 500 mg Venofer infusion over 4-6 hours on Day 0 and repeated on Day 2 to 7 arm 3: 500 mg Venofer over 6 hours, followed within 24 hours by 500 mg Venofer over 6 hours

[ 0, 0, 0 ]

3

[ 0, 0, 0 ]

intervention 1: None intervention 2: None intervention 3: None

intervention 1: Cohort I intervention 2: Cohort II intervention 3: Cohort III

0

null

0

NCT00895232

[ 3 ]

52

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

This is a multi-center, open-label, preference study of two sublingual formulations of buprenorphine HCl, in opioid-dependent patients on buprenorphine maintenance therapy. The objectives of this study are to evaluate the overall preference between two buprenorphine sublingual formulations, after a switch from the marketed tablet (Subutex®) to the new fast dissolving tablet (FDT), in opioid-dependent patients with buprenorphine 8 mg or 16 mg daily maintenance therapy.

null

Opioid Dependency

Buprenorphine tablet Fast dissolving tablet Opioid dependant patients

null

1

arm 1: None

[ 0 ]

2

[ 0, 0 ]

intervention 1: 8 mg or 16 mg daily, sublingual route on Days 1 and 2 intervention 2: 8 mg or 16 mg daily, sublingual route on Days 3, 4, and 5

intervention 1: Buprenorphine hydrochloride marketed sublingual tablet (Subutex) intervention 2: Buprenorphine hydrochloride fast dissolving tablet (FDT)

0

null

0

NCT01075971

[ 3 ]

283

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

true

The purpose of this study is to evaluate the safety and efficacy of 3 different doses of belimumab, administered in addition to standard therapy, in patients with rheumatoid arthritis (RA).

The purpose of this study is to evaluate the safety and efficacy of three different doses of belimumab (1 mg/kg, 4 mg/kg, and 10 mg/kg), administered in addition to standard therapy, compared to placebo plus standard therapy in patients with RA. All patients were to be dosed on Days 0, 14, and 28, then every 28 days for the remainder of 24 weeks. Patients completing the 24-week period could enter a 24-week open-label extension; belimumab patients received the same dose or were switched to 10 mg/kg at the investigator's discretion and former placebo patients received belimumab 10 mg/kg.

Arthritis, Rheumatoid

RA

null

4

arm 1: None arm 2: None arm 3: None arm 4: None

[ 2, 0, 0, 0 ]

4

[ 0, 0, 0, 0 ]

intervention 1: Placebo IV plus standard therapy (SOC) for RA; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 24 weeks in the double-blind period. In the open-label extension period, placebo patients who opted to participate received belimumab 10 mg/kg IV plus SOC every 28 days for an additional 24 weeks. intervention 2: Belimumab 1 mg/kg IV plus standard therapy (SOC) for RA; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 24 weeks in the double-blind period. In the open-label extension period, patients who opted to participate either continued on the same dose of belimumab or may have been switched to belimumab 10 mg/kg at the investigator's discretion for an additional 24 weeks. intervention 3: Belimumab 4 mg/kg IV plus standard therapy (SOC) for RA; belimumab 4 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 24 weeks in the double-blind period. In the open-label extension period, patients who opted to participate either continued on the same dose of belimumab or may have been switched to belimumab 10 mg/kg at the investigator's discretion for an additional 24 weeks. intervention 4: Belimumab 10 mg/kg IV plus standard therapy (SOC) for RA; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 24 weeks in the double-blind period. In the open-label extension period, patients who opted to participate continued on the same dose of belimumab (10 mg/kg) for an additional 24 weeks.

intervention 1: Placebo intervention 2: Belimumab 1 mg/kg intervention 3: Belimumab 4 mg/kg intervention 4: Belimumab 10 mg/kg

63

0

NCT00071812

[ 5 ]

188

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

null

The effects of treatment with different doses of PEGASYS in combination with different doses of ribavirin will be evaluated in patients with CHC genotype 1 who have a high viral titer, body weight greater than 85kg (187lbs) and no prior treatment with interferon. The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals.

null

Hepatitis C, Chronic

null

4

arm 1: Participants received 180 μg of PEG-IFN \[peginterferon\] alfa-2a in 1 mL solution administered \[subcutaneously\] sc, once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered \[orally \] po daily in split doses for 48 weeks arm 2: Participants received 180 μg of PEG-IFN \[peginterferon\] alfa-2a in 1 mL solution administered \[subcutaneously\] sc, once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered \[orally \] po daily in split doses for 48 weeks arm 3: Participants received 270 μg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks arm 4: Participants received 270 μg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks.

[ 1, 0, 0, 0 ]

4

[ 0, 0, 0, 0 ]

intervention 1: 600mg po bid for 48 weeks intervention 2: 800mg po bid for 48 weeks intervention 3: 180 micrograms sc weekly for 48 weeks intervention 4: 270 micrograms sc weekly for 48 weeks

intervention 1: ribavirin [Copegus] intervention 2: ribavirin [Copegus] intervention 3: peginterferon alfa-2a (PEG-IFN alfa-2a) [Pegasys] intervention 4: peginterferon alfa-2a (PEG-IFN alfa-2a) [Pegasys]

25

0

NCT00077649

[ 4 ]

511

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

null

The purpose of this study is to determine whether an experimental anti-anxiety medication is effective in the treatment of Generalized Anxiety Disorder.

Protocol 04-001-01 The primary objective of the study is to assess, under controlled conditions, the safety and efficacy of an experimental anti-anxiety medication relative to placebo in subjects with generalized anxiety disorder (GAD). The secondary objective of the study is to study algorithms for discontinuation of an experimental anti-anxiety medication. Recruiting: Participants are currently being recruited and enrolled.

Anxiety Disorder

Double Blind, Placebo controlled, Safety and Efficacy Generalized Anxiety Disorder

null

0

null

1

[ 0 ]

intervention 1: None

intervention 1: experimental anti-anxiety drug

50

0

NCT00097708

[ 3 ]

606

NON_RANDOMIZED

PARALLEL

1PREVENTION

0NONE

false

0ALL

null

Patients who undergo total hip replacement surgery are at greater risk of getting deep vein thrombosis (blood clots). This study evaluates the safety, tolerability and effectiveness of the study drug, DU-176b, in reducing the occurrence of deep vein thrombosis in patients having total hip replacement surgery.

The primary study objective is to demonstrate prevention of venous thromboembolism in patients undergoing total hip replacement surgery. The secondary objective is to assess the safety and tolerability of DU-176.

Arthroplasty, Replacement, Hip Thrombosis

Deep Vein Thrombosis, Anticoagulant, Venous thromboembolic

null

6

arm 1: 15mg edoxaban administered twice daily (BID) arm 2: 30mg edoxaban administered once daily (QD) arm 3: 30mg edoxaban administered twice daily (BID) arm 4: 60mg edoxaban administered once daily (QD) arm 5: 60mg edoxaban administered twice daily (BID) arm 6: 120mg edoxaban administered once daily (QD)

[ 0, 0, 0, 0, 0, 0 ]

1

[ 0 ]

intervention 1: None

intervention 1: DU-176b

1

Decatur | Georgia | United States | -84.29631 | 33.77483

0

NCT00107900