ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01316926
Conditions: Depressive Disorder
Keywords: fast condition Paroxetine reference/test healthy volunteers Bioequivalence
Sponsor: GlaxoSmithKline
Start date: 2009-09-09; Completion date: 2009-10-05
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The study is prospective, open, randomized, crossover in steady state and the volunteers received multiple doses of the drug test and reference (two periods of drug administration).

Detailed description:
Full title: Relative bioavailability study between the formulations: Paroxetine Hydrochloride 25 mg tablet with controlled release (Paxil CR) manufactured by GlaxoSmithKline Inc. - Mississauga - Canada (test formulation) and Paroxetine Hydrochloride 25 mg tablets with controlled release (Paxil CR) manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico (reference formulation), fasted administration in healthy volunteers for both genders.

The study is open, randomized, crossover in steady state and the volunteers received multiple doses of the drug test and reference (two periods of drug administration).

The population is composed of 60 healthy volunteers, adult of both gender, with age between 18 and 40 years, with a body mass index (BMI) between 18.5 and 27. Volunteers have weight above than 50 kg. 50% of the volunteers recruited are female and 50% male. There are not restrictions regarding the ethnic group.The relative bioavailability of the formulations after oral administration in steady state will be evaluated based on statistical comparisons of relevant pharmacokinetic parameters obtained from data of concentration of drug in blood. The concentration of Paroxetine hydrochloride (controlled release) will be measured by an appropriate analytical method and valid after the drug administration.The Pharmacokinetic samples will be collected at steady state in each fasting period. The safety assessment will include evaluation and clinical monitoring, vital signs monitoring, ECG, and laboratory tests. Adverse events will be monitored throughout the study.

Arms: arm 1: Reference drug administration followed by test drug administration arm 2: Test drug administration followed by Reference drug administration
Interventions: intervention 1: Test formulation intervention 2: Reference formulation
Intervention descriptions: intervention 1: Paroxetine Hydrochloride 25 miligrams (mg) tablet with controlled release (Paxil CR) manufactured by GlaxoSmithKline Inc. - Mississauga - Canada (test formulation) intervention 2: Paroxetine Hydrochloride 25 mg tablets with controlled release (Paxil CR) manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico (reference formulation)

Protocol documents:
Clinical trial NCT02118896
Conditions: Heart Transplantation Liver Transplantation Kidney Transplantation
Keywords: FK506E Heart Transplantation MR4 Tacrolimus Advagraf Kidney Transplantation Renal Transplantation
Sponsor: Astellas Pharma Europe Ltd.
Start date: 2003-02-24; Completion date: 2009-10-07
Enrollment: 850 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study was to offer patients who had participated in one of the phase II PK or phase III studies on FK506E (MR4) the possibility to continue FK506E (MR4) until commercial availability of the drug and to record long term efficacy and safety data.

Detailed description:
The objective of this study was to asses the safety and efficacy of FK506E (MR4) as a long-term treatment in transplant recipients. Only patients who had participated in one of the phase II PK or phase III studies on FK506E (MR4) and had received at least one dose of study medication were enrolled.

Arms: arm 1: Single open arm of FK506E (MR4). Since this was an extension study for many studies, generally the dose given at enrollment was to be continued. The investigator was permitted to adjust the subject's dose and modify the MR4 dose regimen as deemed necessary to minimize Adverse Events (AEs) and maintain effective immunosuppression. MR4 capsules were taken orally, once daily in the morning. MR4 capsules were to be swallowed with fluid (preferably water) on an empty stomach or at least 1 hour before or 2 to 3 hours after a meal. MR4 was supplied as 0.5 mg, 1 mg and 5 mg capsules in amber glass bottles or in blister packs.
Interventions: intervention 1: FK506E
Intervention descriptions: intervention 1: oral

Protocol documents:
Clinical trial NCT00698828
Conditions: Cachexia
Keywords: Cachexia, COPD, Chronic Obstructive Pulmonary Disease
Sponsor: Daiichi Sankyo
Start date: 2008-05-15; Completion date: 2009-10-08
Enrollment: 227 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate SUN11031 for subcutaneous injection compared to placebo in subjects with cachexia associated with Chronic Obstructive Pulmonary Disease (COPD) to determine the effect on physical performance and body composition.

Detailed description:

Arms: arm 1: SUN11031 for injection, low dose, twice daily for 12 weeks arm 2: SUN11031 for injection, higher dose, twice daily for 12 weeks arm 3: Placebo injection, twice daily for 12 weeks
Interventions: intervention 1: Placebo comparator intervention 2: SUN11031 20 μg/kg intervention 3: SUN11031 40 μg/kg
Intervention descriptions: intervention 1: Twice daily subcutaneous injections of placebo for 12 weeks. intervention 2: Twice daily subcutaneous injections of SUN11031 20 μg/kg for 12 weeks. intervention 3: Twice daily subcutaneous injections of SUN11031 40 μg/kg for 12 weeks.

Protocol documents:
Clinical trial NCT00300495
Conditions: Atrial Fibrillation Lung Cancer
Keywords: Atrial fibrillation Lung cancer Pulmonary resection Post-operative complications
Sponsor: Beth Israel Deaconess Medical Center
Start date: 2006-02-01; Completion date: 2009-10-13
Enrollment: 19 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Atrial fibrillation is a very common complication of pulmonary resection. Patients who develop atrial fibrillation require additional treatment and are more likely to stay in the hospital for longer period of time increasing the costs associated with the operation. We propose a randomized controlled trial to see if oral amiodarone given for one week before surgery can prevent atrial fibrillation after pulmonary resection. We plan to evaluate the incidence of atrial fibrillation in patients who received preoperative amiodarone and compare them to the incidence of atrial fibrillation in patients who did not received preoperative amiodarone.

Detailed description:
Atrial fibrillation is a very common complication of pulmonary resection. Patients who develop atrial fibrillation require additional treatment and are more likely to stay in the hospital for longer period of time increasing the costs associated with the operation.

We propose a study to see if oral amiodarone given for one week before surgery can prevent atrial fibrillation after pulmonary resection. We plan to evaluate the incidence of atrial fibrillation in patients who received preoperative amiodarone and compare them to the incidence of atrial fibrillation in patients who did not received preoperative amiodarone.

Arms: arm 1: Perioperative amiodarone arm 2: Control arm, standard care with no perioperative amiodarone
Interventions: intervention 1: Amiodarone intervention 2: Control arm, standard care
Intervention descriptions: intervention 1: Perioperative orally administered intervention 2: Control

Protocol documents:
Clinical trial NCT00659802
Conditions: Ulcerative Colitis
Sponsor: Hutchison Medipharma Limited
Start date: 2008-02-07; Completion date: 2009-10-13
Enrollment: 224 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety and efficacy of HMPL-004 in patients with active mild to moderate ulcerative colitis (UC), compared with placebo.

Detailed description:
This is a double-blind, randomized, placebo-controlled Phase II study conducted in North America (U.S. and Canada) and Europe (Romania and Ukraine) in patients with mild to moderate ulcerative colitis. Treatment consisted of one of 2 doses of HMPL-004 (1200 mg daily or 1800 mg daily, administered in 3 divided doses) or matching placebo. Assessment of treatment effect is based on the Mayo score. Subjects eligible for the study will include those ≥18 years of age with mild to moderate ulcerative colitis, having a Mayo score of 4 to 10, with activity confirmed by endoscopy within 2 weeks prior to study entry, and having a Mayo endoscopy score ≥1. Subjects who are using concomitant mesalamine could enter the study. The randomization will be stratified by mesalamine use or non-use.

Arms: arm 1: Matching dose of placebo will be given orally in capsules three times per day for 56 days. arm 2: A total of 1200 mg of HMPL-004 per day in three divided doses will be given orally in capsules, 200 mg each, for 56 days. arm 3: A total of 1800 mg of HMPL-004 per day in three divided doses will be given orally in capsules, 200 mg each, for 56 days.
Interventions: intervention 1: HMPL-004 low dose intervention 2: Placebo intervention 3: HMPL-004 high dose
Intervention descriptions: intervention 1: HMPL-004, 400 mg (2 x 200 mg) t.i.d. (total of 1200 mg/day). intervention 2: Matching dose of Placebo intervention 3: HMPL-004, 600 mg (3 x 200 mg) t.i.d. (total of 1800 mg/day).

Protocol documents:
Clinical trial NCT00817635
Conditions: Hypertension
Keywords: Blood Pressure Hypertension Resistant Hypertension
Sponsor: Novartis
Start date: 2008-12-22; Completion date: 2009-10-13
Enrollment: 155 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study assessed the blood pressure effect, safety and tolerability of LCI699 compared to placebo and eplerenone in participants with resistant hypertension.

Detailed description:

Arms: arm 1: Following a 2-week placebo run-in period, participants received LCI699 0.25 mg, capsules, orally, twice daily (BID), with or without food for up to 8 weeks. arm 2: Following a 2-week placebo run-in period, participants received LCI699 1 mg, capsules, orally, once daily (QD), with or without food for up to 8 weeks. arm 3: Following a 2-week placebo run-in period, participants received LCI699 0.5 mg, capsules, orally, BID, with or without food for up to 4 weeks, followed by LCI699 1 mg, capsules, orally, BID with or without food for up to 4 weeks. arm 4: Following a 2-week placebo run-in period, participants received eplerenone 50 mg, capsules, orally, BID, with or without food for up to 8 weeks. arm 5: For a 2-week placebo run-in period, followed by 8 weeks of the treatment period, participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food.
Interventions: intervention 1: LCI699 intervention 2: Eplerenone intervention 3: LCI699-matching Placebo intervention 4: Eplerenone-matching Placebo
Intervention descriptions: intervention 1: LCI699 oral capsules intervention 2: Eplerenone oral capsules intervention 3: LCI699-matching placebo oral capsules intervention 4: Eplerenone-matching placebo oral capsules

Protocol documents:
Clinical trial NCT00604968
Conditions: Breast Neoplasms
Sponsor: Merck Sharp & Dohme LLC
Start date: 2007-02-07; Completion date: 2009-10-16
Enrollment: 25 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the safety and efficacy of pegylated liposomal doxorubicin (Caelyx) in elderly patients who are to receive first-line chemotherapy for metastatic or locally advanced breast cancer, not amenable to surgery.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Caelyx (pegylated liposomal doxorubicin; SCH 200746)
Intervention descriptions: intervention 1: Caelyx will be administered intravenously at a dose of 40 mg/m\^2 on day one every 4 weeks until progression, or unacceptable toxicity, or other reason to discontinue the study treatment. The drug is diluted in 250 ml glucose 5% (500 ml for doses \>=90 mg).

Protocol documents:
Clinical trial NCT00321711
Conditions: MDS Myelodysplastic Syndromes Thrombocytopenia
Keywords: MDS Myelodysplastic Syndromes Refractory Cytopenias Thrombocytopenia
Sponsor: Amgen
Start date: 2006-10-01; Completion date: 2009-10-19
Enrollment: 69 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the effect of Romiplostim (AMG 531) on the incidence of clinically significant thrombocytopenic events (grade 3 or 4 and/or receipt of platelet transfusions) in subjects with low or intermediate risk Myelodysplastic Syndrome (MDS) receiving hypomethylating agents. It is hypothesized that Romiplostim administration, at the appropriate dose and schedule, will result in reduction in the incidence of clinically significant thrombocytopenic events in low or intermediate risk MDS subjects receiving hypomethylating agents.

Detailed description:

Arms: arm 1: 500 mcg AMG 531 weekly via subcutaneous injection + 75 mg/m2 azacitidine for 4 cycles arm 2: 750 mcg AMG 531 weekly via subcutaneous injection + 20 mg/m2 decitabine for 4 cycles arm 3: 750 mcg AMG 531 weekly via subcutaneous injection + 75 mg/m2 azacitidine for 4 cycles arm 4: Placebo weekly via subcutaneous injection + 75 mg/m2 azacitidine for 4 cycles arm 5: Placebo weekly via subcutaneous injection + 20 mg/m2 decitabine for 4 cycles
Interventions: intervention 1: Placebo intervention 2: AMG 531 (Romiplostim) intervention 3: Azacitidine intervention 4: Decitabine
Intervention descriptions: intervention 1: Subjects in the control group will receive a placebo subcutaneous injection on a weekly basis during the 4 cycle treatment period. intervention 2: AMG 531 (Romiplostim) will be administered weekly by subcutaneous injection at a dose of 500 or 750 μg during Part A and 750 μg during Part B for the 4 cycle treatment period, depending on randomization. intervention 3: hypomethylating agent intervention 4: hypomethylating agent

Protocol documents:
Clinical trial NCT00812006
Conditions: Migraine
Sponsor: Organon and Co
Start date: 2009-03-24; Completion date: 2009-10-22
Enrollment: 108 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study will provide additional efficacy data for rizatriptan when used for an acute migraine attack in patients already taking topiramate for migraine prophylaxis.

Detailed description:

Arms: arm 1: Treatment Sequence A: rizatriptan, rizatriptan, placebo arm 2: Sequence B: rizatriptan, placebo, rizatriptan arm 3: Sequence C: placebo, rizatriptan, rizatriptan
Interventions: intervention 1: rizatriptan benzoate intervention 2: Comparator: placebo
Intervention descriptions: intervention 1: rizatriptan 10 mg Orally Disintegrating Tablet (ODT) orally for a moderate or severe migraine attack intervention 2: Placebo to rizatriptan 10 mg ODT orally for a moderate or severe migraine attack

Protocol documents:
Clinical trial NCT00532935
Conditions: Type 2 Diabetes Mellitus
Sponsor: Merck Sharp & Dohme LLC
Start date: 2008-01-26; Completion date: 2009-10-23
Enrollment: 517 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A study to evaluate the efficacy and safety of MK0431A in comparison to a commonly used medication in patients with type 2 diabetes

Detailed description:

Arms: arm 1: Sitagliptin phosphate (+) metformin hydrochloride arm 2: pioglitazone
Interventions: intervention 1: sitagliptin phosphate (+) metformin hydrochloride intervention 2: Comparator: pioglitazone
Intervention descriptions: intervention 1: sitagliptin phosphate (+) metformin hydrochloride 50/500 mg tablet bid, titrating up to sitagliptin phosphate (+) metformin hydrochloride 50/1000 mg tablet for an \~32 wk treatment period intervention 2: pioglitazone 30 mg tablet qd, titrating up to 45 mg qd for an \~32-wk treatment period.

Protocol documents:
Clinical trial NCT00673920
Conditions: Rheumatoid Arthritis
Keywords: RA
Sponsor: Genentech, Inc.
Start date: 2008-04-24; Completion date: 2009-10-26
Enrollment: 314 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the efficacy and safety of ocrelizumab, compared to placebo, in patients with active rheumatoid arthritis who have an inadequate response to methotrexate therapy. Patients will be randomized 2:2:1 to receive 1) infusions of ocrelizumab 200mg iv on Days 1 and 15, 2) infusions of ocrelizumab 400mg iv on Day 1 and placebo iv on Day 15, or 3) infusions of placebo iv on Days 1 and 15. At the end of the placebo-controlled treatment period at 24 weeks, patients in groups 1 and 3 will be re-randomized to receive either a single infusion of 400mg iv ocrelizumab or 2 infusions of 200mg iv ocrelizumab, and group 2 will receive a second single infusion of 400mg iv ocrelizumab. All patients will receive a stable dose of concomitant methotrexate (7.5-25mg/week) throughout the study. The anticipated time on study treatment is 1-2 years. Target number of patients to be enrolled in this trial is 300.

Detailed description:

Arms: arm 1: Participants received matching placebo:

* on Day 15 of Cycle 1 (Participants who were administered OCR 400 mg on Day 1 of a Cycle 1 in combination with Methotrexate)
* on both Days 1 and Day 15 of Cycle 1 (Participants who were randomized to the Placebo + Methotrexate group) arm 2: Participants received Ocrelizumab 400mg in combination with Methotrexate on Day 1, Cycle 1. arm 3: Participants received Ocrelizumab 200 mg in combination with Methotrexate on Day 1 and Day 15, Cycle 1. arm 4: Participants who received two 200 mg infusions of Ocrelizumab + Methotraxate during Cycle 1 were re-randomized (1:1 randomization ratio) to receive two infusions of 200 mg Ocrelizumab + Methotraxate during Cycle 2 arm 5: Participants who received two 200 mg infusions of Ocrelizumab + Methotraxate during Cycle 1 were re-randomized (1:1 randomization ratio) to receive a single infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2 arm 6: Participants who received single 400mg infusions of Ocrelizumab + Methotraxate during Cycle 1 received a infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2 arm 7: Participants who received placebo during Cycle 1 were re-randomized (1:1 randomization ratio) to receive two infusions of 200 mg Ocrelizumab + Methotraxate during Cycle 2 arm 8: Participants who received placebo during Cycle 1 were re-randomized (1:1 randomization ratio) to receive single infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2
Interventions: intervention 1: Methotrexate intervention 2: Ocrelizumab intervention 3: Placebo
Intervention descriptions: intervention 1: Oral or parenteral repeating dose intervention 2: Ocrelizumab was administered as a slow intravenous (iv) infusion during each course as either 200 mg on Day 1 and Day 15 (OCR 200×2) or as 400 mg given on Day 1 (OCR 400×1).

Ocrelizumab was administered in combination with Methotrexate. intervention 3: Intravenous repeating dose

Protocol documents:
Clinical trial NCT00652457
Conditions: Huntington's Disease
Sponsor: Jody Corey-Bloom, MD, PhD
Start date: 2004-11-23; Completion date: 2009-10-28
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
To determine if memantine in doses of 10 mg BID affects memory, cognition, and behavior in patients with Huntington's disease (HD).

Detailed description:
Results of several published clinical trials suggest that memantine has a beneficial effect in dementing conditions, such as Alzheimer's disease; however, the effects of memantine on cognitive and behavioral function in HD are unknown. Our hypotheses are that HD patients who are administered memantine will show improved performance on psychometric tests of memory and executive functions in addition to behavior and that patients treated with memantine will show more improvement after six months than after three months of treatment.

Arms: arm 1: Memantine 10 mg BID for three months arm 2: Placebo 10 mg BID for three months
Interventions: intervention 1: Memantine
Intervention descriptions: intervention 1: 10 mg BID x 3 months

Protocol documents:
Clinical trial NCT00833027
Conditions: Diabetes Mellitus
Sponsor: Merck Sharp & Dohme LLC
Start date: 2008-03-01; Completion date: 2009-10-30
Enrollment: 608 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Canadian physicians to experience in real life clinical practice the efficacy and tolerability of adding sitagliptin to their patients who have their glycemic levels inadequately controlled while on metformin

Detailed description:

Arms: arm 1: Sitagliptin
Interventions: intervention 1: sitagliptin phosphate
Intervention descriptions: intervention 1: Sitagliptin 100 mg/day - tablet for 24 weeks

Protocol documents:
Clinical trial NCT00121810
Conditions: Kidney Transplantation
Sponsor: Hoffmann-La Roche
Start date: 2003-08-01; Completion date: 2009-11-01
Enrollment: 305 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This 2-arm study recruited kidney transplant patients who were receiving standard care of calcineurin inhibitors (CNIs, tacrolimus or cyclosporine), CellCept (1.0-1.5 g twice daily) and corticosteroids. They were either randomized to continue this regimen, or CNI therapy was discontinued and replaced by sirolimus therapy (in combination with CellCept and corticosteroids). The effect of these 2 regimens on efficacy, safety and kidney function was evaluated. The anticipated time on study treatment was 1-2 years, and the target sample size was 100-500 individuals.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: mycophenolate mofetil [CellCept] intervention 2: Corticosteroids intervention 3: Calcineurin inhibitors intervention 4: Sirolimus
Intervention descriptions: intervention 1: 1.0-1.5 g oral dose twice daily intervention 2: As prescribed intervention 3: As prescribed intervention 4: As prescribed

Protocol documents:
Clinical trial NCT00145327
Conditions: Osteoporosis
Keywords: Osteoporosis, Zoledronic Acid
Sponsor: Novartis
Start date: 2005-05-01; Completion date: 2009-11-01
Enrollment: 2456 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This extension study is designed to assess the long term safety and efficacy of zoledronic acid in postmenopausal women with osteoporosis who have participated in the CZOL446H2301 (NCT00049829): HORIZON Pivotal Fracture Trial. This extension study began after the 3-year core study ended. Baseline is the same as Year 3.

Detailed description:

Arms: arm 1: Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment. arm 2: Patients who were treated with Zoledronic acid for 3 years in the core study received a single intravenous matching Placebo infusion once a year for 3 years in this extension study. arm 3: Patients who were treated with placebo for 3 years in the core study received 5 mg Zoledronic acid in a single intravenous infusion once a year for 3 years (at Months 36, 48 and 60) in this extension study.
Interventions: intervention 1: Zoledronic Acid intervention 2: Placebo
Intervention descriptions: intervention 1: Zoledronic Acid 5 mg in 100 mL physiologic 0.9% normal saline for intravenous infusion. intervention 2: 100 mL physiologic 0.9% normal saline for intravenous infusion.

Protocol documents: