ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02717754
Conditions: Healthy Volunteer
Sponsor: Hoffmann-La Roche
Start date: 2009-12-01; Completion date: 2010-05-01
Enrollment: 99 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This multi-center, randomized, double-blind, multiple-dose, placebo-controlled, parallel-group study will assess the safety and PK of oseltamivir (Tamiflu) and its carboxylate metabolite, RO0640802 in healthy participants. Participants will be randomized to receive 100 milligrams (mg) oseltamivir, 200 mg oseltamivir, or placebo, all administered intravenously twice daily (BID). The anticipated time on study treatment is 5 days.

Detailed description:

Arms: arm 1: Participants will receive 100 mg oseltamivir intravenous BID for 5 days. arm 2: Participants will receive 200 mg oseltamivir intravenous BID for 5 days. arm 3: Participants will receive oseltamivir matched placebo intravenous BID for 5 days.
Interventions: intervention 1: Oseltamivir intervention 2: Placebo
Intervention descriptions: intervention 1: Oseltamivir will be administered at 100 or 200 mg intravenous BID for 5 days. intervention 2: Oseltamivir matched placebo will be administered intravenous for 5 days.

Protocol documents:
Clinical trial NCT01068262
Conditions: Osteoporosis
Sponsor: Merck Sharp & Dohme LLC
Start date: 2009-12-08; Completion date: 2010-05-02
Enrollment: 44 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will test the weighted average inhibition of u-NTx/Cre (aminoterminal crosslinked telopeptide of Type 1 collagen) and AUC (0-168 hours) of Odanacatib

Detailed description:

Arms: arm 1: Panel A - Healthy male subjects receiving Odanacatib arm 2: Panel A - Healthy male subjects receiving placebo arm 3: Panel B - Healthy female subjects receiving Odanacatib arm 4: Panel B - Healthy female subjects receiving placebo
Interventions: intervention 1: Odanacatib intervention 2: Comparator: Placebo
Intervention descriptions: intervention 1: Oral doses of Odanacatib 50 mg administered once weekly for 4 consecutive weeks intervention 2: Oral Placebo tablet administered once weekly for 4 consecutive weeks

Protocol documents:
Clinical trial NCT00657605
Conditions: Obesity Metabolic Syndrome Diabetes
Keywords: Congenital leptin deficiency Obesity Metabolic syndrome Diabetes
Sponsor: University of Miami
Start date: 2001-06-01; Completion date: 2010-05-04
Enrollment: 3 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will test the hypothesis that leptin contributes to the regulation of the dynamics of human endocrine function.

Detailed description:
The study aims to elucidate the role of leptin in the regulation of human endocrine function approached by a carefully designed, prospective clinical study of the rapidly-sampled dynamics of endocrine rhythms during the course of leptin-replacement treatment in the only three adult individuals identified in the world so far who are leptin-naive due to a functional leptin gene mutation. A study of leptin-naive subjects avoids all confounding factors and pitfalls, because the only bioactive leptin to which they will be exposed is the exogenously administered recombinant protein. Thus, this proposal will permit us to ascertain the endocrine effects of human leptin.

Arms: arm 1: Participants with congenital leptin deficiency will receive the Recombinant methionyl human leptin intervention subcutaneously, once a day with a dose of 0.02 to 0.04 mg/kg (adjusted according to weight loss).
Interventions: intervention 1: Recombinant methionyl human leptin
Intervention descriptions: intervention 1: Recombinant methionyl human leptin, subcutaneous, once a day, 0.02 to 0.04 mg/kg (adjusted according to weight loss), indeterminate duration.

Protocol documents:
Clinical trial NCT00952341
Conditions: Chemotherapy-induced Nausea and Vomiting (CINV)
Keywords: CINV
Sponsor: Merck Sharp & Dohme LLC
Start date: 2009-08-25; Completion date: 2010-05-05
Enrollment: 421 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will demonstrate and confirm the efficacy and safety of MK0869 for the treatment of chemotherapy-induced nausea and vomiting in Chinese patients.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: aprepitant intervention 2: Comparator: Placebo to aprepitant intervention 3: dexamethasone intervention 4: granisetron intervention 5: dexamethasone
Intervention descriptions: intervention 1: Day 1: Oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Oral aprepitant 80 mg intervention 2: Day 1: Placebo to oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Placebo to oral aprepitant 80 mg intervention 3: Day 1: Oral dexamethasone 10.5 mg prior to administration of cisplatin; Days 2, 3, and 4: Oral dexamethasone 7.5 mg intervention 4: Day 1: IV granisetron 3 mg prior to administration of cisplatin intervention 5: Day 1: oral dexamethasone 6 mg prior to the administration of cisplatin; Days 2 and 3: oral dexamethasone 3.75 mg

Protocol documents:
Clinical trial NCT00688688
Conditions: Urinary Bladder, Overactive
Keywords: Frequency Overactive Bladder Urgency Urinary urge incontinence Urinary incontinence Micturition
Sponsor: Astellas Pharma Inc
Start date: 2008-04-25; Completion date: 2010-05-06
Enrollment: 2792 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study is intended to test the safety, tolerability, efficacy of two doses of long term once daily (qd) treatment of Mirabegron in patients with symptoms of overactive bladder and secondly to compare these with active comparator.

Detailed description:
Patients who completed 178-CL-046 (NCT00689104) or 178-CL-047 (NCT00662909) or new patients could be enrolled in this study if eligible.

Arms: arm 1: Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months. arm 2: Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months. arm 3: Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
Interventions: intervention 1: Mirabegron intervention 2: Tolterodine intervention 3: Placebo to Mirabegron intervention 4: Placebo to Tolterodine
Intervention descriptions: intervention 1: Tablets intervention 2: Extended release capsules intervention 3: Matching mirabegron placebo tablets. intervention 4: Matching tolterodine placebo capsules.

Protocol documents:
Clinical trial NCT00089674
Conditions: Prostate Cancer
Keywords: Prostate Cancer Bone Loss with Prostate Cancer Treatment of bone loss in patients undergoing androgen deprivation therapy (ADT) for non-metastatic prostate cancer (PC).
Sponsor: Amgen
Start date: 2004-08-01; Completion date: 2010-05-11
Enrollment: 1468 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate AMG 162 in the treatment of bone loss in subjects undergoing Androgen-Deprivation Therapy for Non-metastatic Prostate Cancer.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: AMG 162 intervention 2: Placebo
Intervention descriptions: intervention 1: 60 mg (1.0mL) administered subcutaneously at Day 1, Months 6, 12, 18, 24, 30 intervention 2: 60 mg (1.0mL) administered subcutaneously at Day 1, Months 6, 12, 18, 24, 30

Protocol documents:
Clinical trial NCT01088711
Conditions: Type 2 Diabetes (T2D)
Keywords: Type 2 diabetes (T2D)
Sponsor: Merck Sharp & Dohme LLC
Start date: 2010-03-11; Completion date: 2010-05-11
Enrollment: 32 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will test the safety and tolerability of omarigliptin. It is hypothesized that administration of once-weekly omarigliptin in obese but otherwise healthy participants, and in obese participants with Type 2 diabetes (T2D) will be sufficiently safe and well tolerated to permit continued clinical investigation.

Detailed description:

Arms: arm 1: Obese healthy participants receive once-weekly omarigliptin 50 mg by mouth for 4 weeks (Panel A). arm 2: Obese healthy participants receive once-weekly placebo by mouth for 4 weeks (Panel A). arm 3: Obese participants with T2D receive once-weekly omarigliptin 50 mg by mouth for 4 weeks (Panel B). arm 4: Obese participants with T2D receive once-weekly placebo by mouth for 4 weeks (Panel B).
Interventions: intervention 1: Omarigliptin intervention 2: Placebo
Intervention descriptions: intervention 1: Once-weekly 50 mg capsule intervention 2: Once-weekly placebo capsule

Protocol documents:
Clinical trial NCT00407550
Conditions: Lung Cancer
Keywords: stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer recurrent non-small cell lung cancer
Sponsor: Mayo Clinic
Start date: 2006-11-01; Completion date: 2010-05-12
Enrollment: 19 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
RATIONALE: Pemetrexed disodium may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving pemetrexed disodium together with gemcitabine may kill more tumor cells.

PURPOSE: This randomized phase II trial is studying two different schedules of pemetrexed disodium and gemcitabine to compare how well they work in treating patients with stage IIIB or stage IV non-small cell lung cancer.

Detailed description:
OBJECTIVES:

Primary

* Compare response rates in patients with stage IIIB or IV non-small cell lung cancer treated with two different treatment schedules of pemetrexed disodium and gemcitabine hydrochloride.

Secondary

* Compare time-to-event efficacy variables in patients treated with these regimens.
* Compare progression-free and overall survival of patients treated with these regimens.
* Determine the overall toxicity of these regimens in these patients.

OUTLINE: This is a multicenter, open-label, randomized study. Patients are stratified according to disease stage (IIIB vs IV) and ECOG performance status (0 vs 1). Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive pemetrexed disodium IV over 10 minutes and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
* Arm II: Patients receive pemetrexed disodium IV over 10 minutes and gemcitabine hydrochloride IV over 30 minutes on day 1. Treatment repeats every 14 days for up to 9 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for up to 2 years.

PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.

Arms: arm 1: Treat subjects with 2 dosings/cycle of Gemzar x6 cycles. arm 2: Treat subjects with 1 dosing/cycle of Gemzar x9 cycles.
Interventions: intervention 1: gemcitabine HCL intervention 2: pemetrexed disodium intervention 3: gemcitabine HCL
Intervention descriptions: intervention 1: 1250 mg/m\^2 administered through 250 cc NS (normal saline) IV (intravenous) infusion over 30 minutes at days 1 \& 8 of each cycle (21 days) x6 cycles. intervention 2: 500 mg/m\^2 administered through 100 mL NS IV infusion over 10 minutes at day 1 of each cycle. intervention 3: 1500 mg/m\^2 administered through 250 cc NS IV infusion over 30 minutes at days 1 of each cycle (14 days) x9 cycles.

Protocol documents:
Clinical trial NCT00448539
Conditions: Refractory Partial Onset Seizures
Keywords: Refractory Partial Onset Seizures, epilepsy
Sponsor: Eisai Inc.
Start date: 2007-03-15; Completion date: 2010-05-14
Enrollment: 286 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This was an open-label extension study in adolescent and adult (between 12 and 80 years old) participants who had completed their participation in Study E2080-A001-301. The main objective of this study was to evaluate the safety and efficacy of long-term administration of rufinamide for the control of epileptic seizures in participants who had refractory partial seizures despite treatment with a maximum of three approved antiepileptic drugs (AEDs).

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Rufinamide
Intervention descriptions: intervention 1: Dose will be maintained within the range of 2400 to 4800 mg/day (i.e., 1200 to 2400 mg twice daily).

Protocol documents:
Clinical trial NCT00759876
Conditions: Duchenne Muscular Dystrophy
Keywords: Duchenne muscular dystrophy Nonsense mutation Premature stop codon DMD PTC124 Ataluren
Sponsor: PTC Therapeutics
Start date: 2008-08-13; Completion date: 2010-05-17
Enrollment: 36 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Duchenne muscular dystrophy (DMD) is a genetic disorder that develops in boys. It is caused by a mutation in the gene for dystrophin, a protein that is important for maintaining normal muscle structure and function. Loss of dystrophin causes muscle fragility that leads to weakness and loss of walking ability during childhood and teenage years. A specific type of mutation, called a nonsense (premature stop codon) mutation, is the cause of DMD in approximately 10-15% of boys with the disease. Ataluren is an orally-delivered, investigational drug that has the potential to overcome the effects of the nonsense mutation. This study is a Phase 2a extension trial that will evaluate the long-term safety of ataluren in boys with nonsense mutation DMD, as determined by adverse events and laboratory abnormalities. The study will also assess changes in walking, muscle function, strength, and other important clinical and laboratory measures.

Detailed description:
This Phase 2a, multicenter, open-label safety and efficacy study will be performed at 3 sites in the United States. The study will enroll up to 38 participants with nonsense mutation Duchenne muscular dystrophy who participated in a previous Phase 2a study of ataluren (Protocol Number PTC124-GD-004-DMD \[NCT00264888\]). Participants will receive study drug 3 times per day (at breakfast, lunch, and dinner) for approximately 96 weeks (approximately 2 years). Study assessments will be performed at clinic visits during screening, every 6 weeks for the first 24 weeks, and then every 12 weeks until the end of the study. Additional safety laboratory testing, which may be performed at the investigational site or at an accredited local laboratory or clinic, is required every 3 weeks for the first 24 weeks and then every 6 weeks from Week 24 to Week 48. Participants will have a biceps muscle biopsy before ataluren treatment and again after 24 weeks of ataluren treatment to evaluate changes in muscle dystrophin expression. An evaluation of the effects of ataluren on corticosteroid pharmacokinetics will be performed. Associated with this ataluren clinical trial is a substudy that will use magnetic resonance evaluations to assess changes in the composition of muscles of the legs.

Arms: arm 1: Participants will receive ataluren 3 times per day with meals at doses of 20 milligrams per kilogram (mg/kg) (breakfast), 20 mg/kg (lunch), and 40 mg/kg (dinner) for up to 89 weeks.
Interventions: intervention 1: Ataluren
Intervention descriptions: intervention 1: Ataluren will be provided as a vanilla-flavored powder to be mixed with milk. Dosing based on participant body weight

Protocol documents:
Clinical trial NCT00847379
Conditions: Duchenne Muscular Dystrophy Becker Muscular Dystrophy
Keywords: Duchenne muscular dystrophy Becker muscular dystrophy Nonsense mutation Premature stop codon DMD BMD Ataluren PTC124
Sponsor: PTC Therapeutics
Start date: 2009-01-31; Completion date: 2010-05-24
Enrollment: 173 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Duchenne/Becker muscular dystrophy (DMD/BMD) is a genetic disorder that develops in boys. It is caused by a mutation in the gene for dystrophin, a protein that is important for maintaining normal muscle structure and function. Loss of dystrophin causes muscle fragility that leads to weakness and loss of walking ability during childhood and teenage years. A specific type of mutation, called a nonsense (premature stop codon) mutation is the cause of DMD/BMD in approximately 10-15% of boys with the disease. Ataluren (PTC124) is an orally delivered, investigational drug that has the potential to overcome the effects of the nonsense mutation. This study is a Phase 2b extension trial that will evaluate the long-term safety of ataluren (PTC124) in boys with nonsense mutation DMD/BMD, as determined by adverse events and laboratory abnormalities. The study will also assess changes in walking, muscle function, and other important clinical and laboratory measures.

Detailed description:
This is a Phase 2b, international, multicenter, open-label extension study for participants who successfully completed blinded study drug in Study 007. This extension study will evaluate the long-term administration of ataluren administered 3 times per day (TID) at morning, midday, and evening doses of 20, 20, and 40 milligrams/kilogram (mg/kg), respectively, in participants with nonsense mutation Duchenne/Becker muscular dystrophy (nmDBMD).

Arms: arm 1: All participants will receive ataluren suspension orally three times a day (TID), 20 mg/kg at morning, 20 mg/kg at midday, and 40 mg/kg at evening (total daily dose 80 mg/kg) for up to 96 weeks in this study. Any participant who was receiving a reduced dose of ataluren at the end of treatment visit in study PTC124-GD-007-DMD, will be initiated ataluren therapy in this extension study at the 5-, 5-, and 10-mg/kg dose level; dose will be increased to 10, 10, and 20 mg/kg at Week 6 and to 20, 20, and 40 mg/kg at Week 12, if the preceding dose level is well tolerated.
Interventions: intervention 1: Ataluren
Intervention descriptions: intervention 1: Ataluren oral powder for suspension will be administered as per dose and schedule specified in the arm.

Protocol documents:
Clinical trial NCT00430716
Conditions: Pulmonary Arterial Hypertension
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2008-04-08; Completion date: 2010-05-25
Enrollment: 130 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To demonstrate a dose response for 1 mg, 5 mg and 20 mg TID oral sildenafil for the treatment of subjects with PAH.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: Open label extension from week 12 to week 24.
Interventions: intervention 1: Sildenafil citrate intervention 2: Sildenafil citrate intervention 3: Sildenafil citrate intervention 4: Sildenafil citrate
Intervention descriptions: intervention 1: oral, 20 mg, tid intervention 2: oral 1 mg, tid intervention 3: oral 5 mg, tid intervention 4: oral 20 mg, tid

Protocol documents:
Clinical trial NCT00810277
Conditions: Rheumatoid Arthritis
Sponsor: Hoffmann-La Roche
Start date: 2008-11-30; Completion date: 2010-05-26
Enrollment: 14 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This single arm study will assess the safety and efficacy of tocilizumab in patients with moderate to severe active rheumatoid arthritis who have an inadequate response to current non-biologic DMARDs. Patients will receive iv infusions of tocilizumab 8mg/kg every 4 weeks for a total of 6 infusions, either as monotherapy or in combination with their current non-biologic DMARDs.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: tocilizumab [RoActemra/Actemra]
Intervention descriptions: intervention 1: 8mg/kg iv every 4 weeks for 24 weeks

Protocol documents:
Clinical trial NCT00880009
Conditions: Breast Cancer
Sponsor: Pfizer
Start date: 2009-07-30; Completion date: 2010-05-31
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: 

Brief summary:
This is a phase 2 study of bosutinib administered in combination with letrozole versus letrozole alone in post-menopausal women with breast cancer. This is a 2-part study. Subjects in part 1 will receive bosutinib and letrozole daily, and will be closely monitored for 28 days. The second part will proceed with subjects receiving a dose that is determined to be safe based on the safety evaluation of the first part. Eligible subjects will be randomly assigned to receive either bosutinib daily combined with daily letrozole, or daily letrozole alone for a specified period of time. Subjects will be followed up for survival after study drug discontinuation.

Detailed description:
This study was terminated on 19 April 2009 due to unfavorable risk benefit ratio of Bosutinib in combination with Letrozole including one confirmed Hy's law case. 37.5% of patients had treatment related liver events with the majority of severe events resulting in permanent study treatment discontinuation.

Arms: arm 1: Combination of Bosutinib and Letrozole arm 2: Letrozole
Interventions: intervention 1: Bosutinib intervention 2: Letrozole intervention 3: Letrozole
Intervention descriptions: intervention 1: 400mg (4x100)mg tablets once daily during the active phase of treatment until Disease Progression, unacceptable toxicity or withdraw of consents occurs intervention 2: 2.5 mg - one tablet per day- once daily during the active phase of treatment until Disease Progression, unacceptable toxicity or withdraw of consents occurs intervention 3: 2.5 mg - one tablet per day- once daily during the active phase of treatment until Disease Progression, unacceptable toxicity or withdraw of consents occurs

Protocol documents: