ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01238640
Conditions: Tobacco Dependence
Keywords: Smoking Cessation Nicotine
Sponsor: McNeil AB
Start date: 2008-08-01; Completion date: 2008-11-01
Enrollment: 84 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to assess the bioequivalence between two new oral nicotine replacement therapy products and Nicorette® microtab.

Detailed description:
The trial has a single-dose, randomized, crossover design and includes 84 subjects. The investigational products will be given as single doses at separate treatment visits. Periods without Nicotine Replacement Therapy (NRT), lasting for at least 36 hours, will separate treatment visits. At each treatment visit, blood for pharmacokinetic analyses will be sampled immediately before, and at 5, 10, 15, 20, 30, and 45 minutes, as well as at 1, 1.25, 1.5, 2, 3, 4, 6, 8, and 10 hours after start of product administration. The time until complete tablet dissolution will be recorded. Subjects will also be monitored to capture any adverse events that may occur. Treatment labels will be concealed from subjects and study personnel.

Arms: arm 1: An experimental 2 mg nicotine product coded "STD" arm 2: An experimental 2 mg nicotine product coded "STE" arm 3: A comparative 2 mg marketed nicotine product called Nicorette Microtab
Interventions: intervention 1: Code STD intervention 2: Code STE intervention 3: Nicorette Microtab
Intervention descriptions: intervention 1: 2 mg Single-dose of experimental nicotine product coded "STD" intervention 2: 2 mg Single-dose of experimental nicotine product coded "STE" intervention 3: A comparative 2 mg Single-dose of marketed tablet

Protocol documents:
Clinical trial NCT01742897
Conditions: Osteoarthritis, Knee
Keywords: Osteoarthritis, Knee Transdermal therapeutic system (TTS) fentanyl Durogesic
Sponsor: Janssen-Cilag Ltd.,Thailand
Start date: 2008-08-01; Completion date: 2008-11-01
Enrollment: 35 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of Transdermal therapeutic system (TTS) fentanyl patches (transdermal patch containing a drug that is put on the skin so the drug will enter the body through the skin) in knee osteoarthritis (disorder, which is seen mostly in older persons, in which the joints become painful and stiff) participants with moderate to severe pain.

Detailed description:
This is an open-label (a medical research study in which participants and researchers are told which treatments the participants are receiving, "unblinded"), single-arm, prospective study (study following participants forward in time) of TTS-fentanyl matrix form in knee osteoarthritis participants. The study consists of 3 phases: a screening phase, an open label treatment phase consisting of 2 periods, and an evaluation phase. The first patch will be applied on the first day of treatment phase by the investigator, and sufficient patches until Day 30 will be provided to the participant with the instructions to apply the patch. The TTS-fentanyl dose will normally be increased, if needed by 12.5 microgram per hour taking into account the daily dose of supplemental paracetamol required by the participant. Efficacy with regard to pain control will be recorded principally by the participant via questionnaires in a daily diary. This record will be used to support more detailed assessments at study visits on Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire. Participants' safety will be monitored.

Arms: arm 1: Transdermal therapeutic system (TTS) fentanyl patches releasing at the rate of 12.5 microgram per hour for 3 days. The patches will be replaced every 3 days until 30 days.
Interventions: intervention 1: TTS-fentanyl
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02169895
Conditions: Parkinson's Disease (PD)
Keywords: Parkinson's disease (PD) Opicapone Bia 9-1067
Sponsor: Bial - Portela C S.A.
Start date: 2008-09-01; Completion date: 2008-11-01
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
To investigate the effect of three single oral doses of BIA 9-1067 (25 mg, 50 mg and 100 mg) on the levodopa pharmacokinetics when administered in combination with a single-dose of immediate-release levodopa/benserazide 100/25 mg (Prolopa® 100-25)

Detailed description:

Arms: arm 1: Period 1: BIA 9-1067 25 mg Period 2: BIA 9-1067 50 mg Period 3: BIA 9-1067 100 mg Period 4: Placebo

Every period with concomitant single oral administration of Prolopa® 100-25 arm 2: Period 1: BIA 9-1067 50 mg Period 2: BIA 9-1067 100 mg Period 3: Placebo Period 4: BIA 9-1067 25 mg

Every period with concomitant single oral administration of Prolopa® 100-25 arm 3: Period 1: BIA 9-1067 100 mg Period 2: Placebo Period 3: BIA 9-1067 25 mg Period 4: BIA 9-1067 50 mg

Every period with concomitant single oral administration of Prolopa® 100-25 arm 4: Period 1: Placebo Period 2: BIA 9-1067 25 mg Period 3: BIA 9-1067 50 mg Period 4: BIA 9-1067 100 mg

Every period with concomitant single oral administration of Prolopa® 100-25
Interventions: intervention 1: BIA 9-1067 intervention 2: Placebo intervention 3: Prolopa®
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: levodopa/benserazide 100/25 mg

Protocol documents:
Clinical trial NCT02231177
Conditions: Pulmonary Disease, Chronic Obstructive
Sponsor: Boehringer Ingelheim
Start date: 2008-06-01; Completion date: 2008-11-01
Enrollment: 47 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to compare the systemic exposure to BI 1744 BS and tiotropium at steady state following inhalation of the fixed dose combination (FDC) of 10 μg BI 1744 CL plus 5 μg tiotropium bromide with the systemic exposure to BI 1744 BS and tiotropium at steady state following inhalation of the single agents, i.e., 10 μg BI 1744 CL and 5 μg tiotropium bromide, when administered once-daily via the Respimat® Inhaler for 21 days.

The secondary objectives were to compare the safety and tolerability (adverse events, 12-lead electrocardiogram recordings, pulmonary function testing) of BI 1744 CL and tiotropium bromide when administered as fixed dose combination or as single-agent therapy.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: BI 1744 CL intervention 2: BI 1744 CL/Tiotropium FDC intervention 3: Tiotropium
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT00406029
Conditions: Parkinson Disease Movement Disorders Central Nervous System Diseases Neurodegenerative Diseases Brain Diseases
Sponsor: Merck Sharp & Dohme LLC
Start date: 2006-11-20; Completion date: 2008-11-03
Enrollment: 253 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to assess the efficacy and safety of a range of doses of SCH 420814 (preladenant) when used together with a stable dose of L-dopa/dopa decarboxylase inhibitor to treat Parkinson's disease. In this study, we will be comparing 3 doses (1 mg, 2 mg, and 5 mg taken twice a day) of preladenant with placebo (sugar pill). Following an Interim Analysis (temporary hold for new enrollment-ongoing subjects will continue on treatment) to review drug safety, a new dose group of 10 mg (taken twice a day) may be added.

Approximately 160 participants will be randomized in this study in approximately 22 study centers worldwide for the first part of this study. Following the Interim Analysis, 40 new participants may be added, for a total of 200 participants. The study is double blind, which means neither you nor your study doctor will know whether you are receiving the study medication or placebo.

Detailed description:

Arms: arm 1: Participants received preladenant 1 mg twice daily (BID) during the 12-week treatment period. arm 2: Participants received preladenant 2 mg BID during the 12-week treatment period. arm 3: Participants received preladenant 5 mg BID during the 12-week treatment period. arm 4: Participants received preladenant 10 mg BID during the 12-week treatment period. arm 5: Participants received preladenant matching placebo BID during the 12-week treatment period.
Interventions: intervention 1: Preladenant intervention 2: Preladenant intervention 3: Preladenant intervention 4: Preladenant intervention 5: Placebo intervention 6: L-dopa intervention 7: Other Parkinson's Disease treatments
Intervention descriptions: intervention 1: 1 mg BID capsules intervention 2: 2 mg BID capsules intervention 3: 5 mg BID capsules intervention 4: 10 mg BID capsules intervention 5: BID capsules intervention 6: Participants must receive L-dopa as part of their usual ongoing treatment for Parkinson's Disease. L-dopa is often administered concomitantly with a dopa decarboxylase inhibitor (e.g., carbidopa). intervention 7: Participants may also receive other drugs as part of their usual ongoing treatment for Parkinson's Disease, such as dopamine agonists (e.g., pramipexole) and/or the catechol-O-methyl transferase (COMT) inhibitor entacapone.

Protocol documents:
Clinical trial NCT00287716
Conditions: Idiopathic Pulmonary Fibrosis
Keywords: Idiopathic Pulmonary Fibrosis Lung Pirfenidone InterMune
Sponsor: Genentech, Inc.
Start date: 2006-07-14; Completion date: 2008-11-10
Enrollment: 435 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objectives of this study are to assess the safety and efficacy of treatment with pirfenidone 2403 milligrams per day (mg/d) compared with placebo in patients with idiopathic pulmonary fibrosis (IPF), to assess the safety and efficacy of treatment with pirfenidone 1197 mg/d in patients with idiopathic pulmonary fibrosis and to characterize the pharmacokinetic disposition of pirfenidone in patients with idiopathic pulmonary fibrosis.

Detailed description:
This is a Phase 3, randomized, double blind, placebo-controlled, three-arm, safety and efficacy study of pirfenidone in patients with idiopathic pulmonary fibrosis. Approximately 400 patients at approximately 70 centers will be randomly assigned (2:2:1) to receive either 2403 milligrams (mg) of pirfenidone, placebo equivalent, or 1197 mg of pirfenidone administered in divided doses three times per day (TID) with food. Patients will be randomized by geographic region.

Patients will receive blinded study treatment from the time of randomization until the last patient randomized has been treated for 72 weeks. A Data Monitoring Committee (DMC) will periodically review safety and efficacy data to ensure patient safety.

After week 72, patients who meet the Progression of Disease (POD) definition, which is a ≥ 10% absolute decrease in percent predicted FVC or a ≥ 15% absolute decrease in percent predicted carbon monoxide diffusing capacity (DLco), will be eligible to receive permitted IPF therapies in addition to their blinded study drug. Permitted IPF therapies include corticosteroids, azathioprine, cyclophosphamide and N-acetyl-cysteine (with restrictions).

Arms: arm 1: Active arm 1, 2403 mg/day pirfenidone dose group. arm 2: Active arm 2, 1197 mg/day pirfenidone. arm 3: Placebo equivalent.
Interventions: intervention 1: Pirfenidone intervention 2: Placebo
Intervention descriptions: intervention 1: 1197 or 2403 mg/day given orally, and administered in divided doses three times daily with food, for the duration of the study. intervention 2: Placebo equivalent, given orally, and administered in divided doses three times daily with food, for the duration of the study.

Protocol documents:
Clinical trial NCT00706914
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Airflow Obstruction, Chronic Chronic Airflow Obstruction Chronic Obstructive Pulmonary Disease Chronic Obstructive Airway Disease Chronic Obstructive Lung Disease COPD COAD
Sponsor: AstraZeneca
Start date: 2008-06-30; Completion date: 2008-11-11
Enrollment: 156 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This exploratory study will compare the efficacy of the fixed-dose combination (FDC) of aclidinium bromide and formoterol fumarate once daily in the morning and placebo once in the evening vs. the FDC once daily in the morning and formoterol fumarate once in the evening vs. formoterol fumarate twice daily. The study will assess pulmonary function and symptoms in patients with moderate to severe COPD.

Detailed description:

Arms: arm 1: Aclidinium bromide 200 µg/ formoterol fumarate 12 µg fixed-dose combination (FDC) once-daily in the morning, plus placebo once-daily in the evening arm 2: Aclidinium bromide 200 µg/formoterol fumarate 12 µg FDC once-daily in the morning, plus formoterol fumarate 12µg once-daily in the evening arm 3: Formoterol fumarate 12 µg twice-daily (BID)
Interventions: intervention 1: Once-daily aclidinium/formoterol intervention 2: Twice-daily formoterol fumarate intervention 3: Placebo to formoterol fumarate intervention 4: Once-daily formoterol fumarate
Intervention descriptions: intervention 1: Inhaled aclidinium bromide 200 µg/formoterol fumarate 12 µg fixed-dose combination once-daily in the morning intervention 2: Inhaled formoterol fumarate 12 µg twice-daily (BID) intervention 3: Inhaled placebo to formoterol fumarate once-daily in the evening intervention 4: Inhaled formoterol fumarate 12 μg once-daily in the evening

Protocol documents:
Clinical trial NCT00337727
Conditions: Chemotherapy-Induced Nausea and Vomiting
Sponsor: Merck Sharp & Dohme LLC
Start date: 2007-01-01; Completion date: 2008-11-19
Enrollment: 848 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study will test aprepitant for the prevention of CINV in patients receiving their initial cycle of Moderately Emetogenic Chemotherapy (MEC). Patients receiving more then one cycle of chemotherapy may opt to participate in an optional second cycle during which the patient will receive the same antiemetic regimen as cycle 1, except that an IV formulation of aprepitant will be given in place of the oral formulation on study day one. Study drug administration on subsequent days will be given orally as in cycle 1.

Detailed description:

Arms: arm 1: Arm 1: Day 1: aprepitant 125 mg capsule; ondansetron 8 mg capsule prior to chemotherapy and 1 8mg capsule 12 hrs after first dose; dexamethasone 12 mg tablets + 2 dexamethasone Pbo tablets. Day 2: Aprepitant 80 mg capsule; Ondansetron 8 mg capsule every 12 hours Day 3: Aprepitant 80 mg capsule Ondansetron 8 mg capsule every 12 hours. arm 2: Arm 2: Day 1: Aprepitant 125 mg Pbo capsule; Ondansetron 8 mg capsule prior to chemotherapy and 8 mg capsule 12 hours after first dose; Dexamethasone 20 mg tablets. Day 2: Aprepitant 80 mg Pbo capsule; Ondansetron 8 mg capsule every 12 hours; Day 3: Aprepitant 80 mg Pbo capsule; Ondansetron 8 mg capsule every 12 hours. 3 Day treatment period Optional cycle 2 is being offered to patients. Optional cycle 2 will substitute aprepitant with fosaprepitant dimeglumine 115 mg or Pbo on day 1. All other dosing regimen will remain the same as cycle 1.
Interventions: intervention 1: aprepitant intervention 2: Comparator: ondansetron intervention 3: Comparator: dexamethasone intervention 4: Comparator: fosaprepitant dimeglumine intervention 5: Comparator; Placebo (unspecified) intervention 6: Comparator; Placebo (unspecified)
Intervention descriptions: intervention 1: aprepitant 125 mg capsule; aprepitant 80 mg capsule Three day treatment period. intervention 2: Ondansetron 8 mg capsule Three day treatment period. intervention 3: dexamethasone 12 mg tablets; 20 mg tablets Three day treatment period. intervention 4: fosaprepitant dimeglumine 115 mg intervention 5: dexamethasone 12mg Pbo tablets. intervention 6: Aprepitant 80 mg \& 125 mg Pbo capsules.

Protocol documents:
Clinical trial NCT00437658
Conditions: Endometriosis
Sponsor: AbbVie
Start date: 2006-12-11; Completion date: 2008-11-24
Enrollment: 252 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to assess the effects of elagolix versus subcutaneous depot medroxyprogesterone acetate (DMPA-SC; also known as depo-provera) on bone mineral density (BMD) during treatment for 24 weeks with a subsequent 24-week post-treatment period.

Detailed description:

Arms: arm 1: Participants received elagolix 75 mg orally twice a day (BID) for 24 weeks and placebo to DMPA-SC by subcutaneous injection at weeks 1 and 12. arm 2: Participants received elagolix 150 mg orally once a day (QD) for 24 weeks and placebo to DMPA-SC by subcutaneous injection at weeks 1 and 12. arm 3: Participants received placebo to elagolix orally once a day for 24 weeks and DMPA-SC 104 mg by subcutaneous injection at weeks 1 and 12.
Interventions: intervention 1: Elagolix intervention 2: Subcutaneous depot medroxyprogesterone acetate (DMPA-SC) intervention 3: Placebo to Elagolix intervention 4: Placebo to DMPA-SC
Intervention descriptions: intervention 1: Provided as tablets for oral administration intervention 2: Provided for subcutaneous injection in a prefilled syringe, 104 mg/0.65 mL per syringe. intervention 3: Matching placebo tablets for oral administration intervention 4: Matching placebo for subcutaneous injection in a pre-filled syringe

Protocol documents:
Clinical trial NCT00358449
Conditions: Oesophagitis, Eosinophilic
Keywords: eosinophilic mepolizumab esophagitis
Sponsor: GlaxoSmithKline
Start date: 2006-09-11; Completion date: 2008-11-25
Enrollment: 84 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of intravenous mepolizumab in pediatric subjects with eosinophilic esophagitis.

Detailed description:

Arms: arm 1: Participants received mepolizumab 0.55 milligrams (mg)/kilogram (kg) by intravenous (IV) infusion for 30 minutes on Day 1, Week 4 and Week 8. arm 2: Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8. arm 3: Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
Interventions: intervention 1: mepolizumab
Intervention descriptions: intervention 1: Participants received mepolizumab 0.55 milligrams (mg)/kilogram (kg), 2.5 mg/kg , or 10 mg/kg by intravenous (IV) infusion for 30 minutes on Day 1, Week 4 and Week 8.

Protocol documents:
Clinical trial NCT00971867
Conditions: Head and Neck Cancer
Sponsor: Bristol-Myers Squibb
Start date: 2006-08-04; Completion date: 2008-11-26
Enrollment: 11 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to provide access to paclitaxel therapy to subjects with advanced head and neck cancer who have completed the previous late phase 2 study (CA139-388) and should have continued therapy with paclitaxel as the discretion of the investigator, and to evaluate the frequency and the severity of observed adverse reactions in treated subjects

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Paclitaxel
Intervention descriptions: intervention 1: Solution, I.V., 100 mg/m2 Weekly for 6 of 7 weeks, Until disease progression or unacceptable toxicity became apparent

Protocol documents:
Clinical trial NCT00689273
Conditions: Osteoarthritis, Knee
Keywords: PF-04136309 CCR2 osteoarthritic pain knee phase 2 placebo multicenter double-blind placebo-controlled
Sponsor: Pfizer
Start date: 2008-08-05; Completion date: 2008-11-27
Enrollment: 159 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the efficacy, safety, tolerability, pharmacodynamics, and pharmacokinetics in patients with osteoarthritic pain of the knee. The most painful knee joint will be identified as the index joint at screening, and this joint will be used for all pain assessments throughout the study.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: PF-04136309 intervention 2: Placebo
Intervention descriptions: intervention 1: 125 mg capsules. Dose will be 4 capsules BID for 2 weeks for a total of 500 mg for each dosing interval. intervention 2: Placebo will be matched to PF-04136309. Dose, frequency, and duration same as PF-04136309.

Protocol documents:
Clinical trial NCT00312494
Conditions: Bipolar Disorder
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2006-04-01; Completion date: 2008-12-01
Enrollment: 680 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
3-week study to evaluate efficacy and safety of ziprasidone with either lithium or divalproex in acutely manic subjects

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Placebo intervention 2: Ziprasidone intervention 3: Ziprasidone
Intervention descriptions: intervention 1: Placebo with mood stabilizer (either lithium or divalproex) intervention 2: Flexible dosing, 20-40mg BID, with a mood stabilizer (either lithium or divalproex) intervention 3: Flexible dosing, 60-80mg BID, with a mood stabilizer (either lithium or divalproex)

Protocol documents:
Clinical trial NCT00326911
Conditions: Metastatic Pancreatic Cancer
Sponsor: Eli Lilly and Company
Start date: 2006-05-01; Completion date: 2008-12-01
Enrollment: 61 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Eligible patients with metastatic pancreatic cancer will be treated with dual agent monoclonal antibody consisting of cetuximab and bevacizumab alone or in combination with gemcitabine

Detailed description:

Arms: arm 1: Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. All medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab. arm 2: Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
Interventions: intervention 1: cetuximab intervention 2: bevacizumab intervention 3: gemcitabine intervention 4: cetuximab
Intervention descriptions: intervention 1: I.V. infusion of 400 mg/m2 (over 120 minutes) on day 1 of cycle 1 intervention 2: 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. intervention 3: 1000 mg/m2 administered intravenously at 10 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. intervention 4: I.V.infusions of 250 mg/m2 (over 60 minutes) weekly

Protocol documents: