ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01425190
Conditions: Hepatitis C, Chronic
Sponsor: Merck Sharp & Dohme LLC
Start date: 2012-01-04; Completion date: 2013-03-20
Enrollment: 16 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a study to determine the pharmacokinetics (PK) and weight-based dose of boceprevir following single oral dose administration in Chronic Hepatitis C Virus (HCV) pediatric participants.

Detailed description:

Arms: arm 1: Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such pudding or applesauce. The first 4 participants were treated with a 11.4 mg/kg dose of boceprevir powder. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants. arm 2: Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such as pudding or applesauce. The first 4 participants were treated with boceprevir at a dose contingent on the PK and safety results in Cohort 1. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants. arm 3: Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such as pudding or applesauce. The first 4 participants were treated with boceprevir at a dose contingent on the PK and safety results in Cohort 2. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
Interventions: intervention 1: Boceprevir
Intervention descriptions: intervention 1: Single dose of boceprevir powder prior to breakfast in a dosing vehicle of chocolate pudding (i.e., a mousse or custard), apple sauce, Nutella, fruit pudding such as strawberry, cherry, or raspberry pudding, or yogurt or a similar semi-solid product into which the boceprevir powder can be evenly stirred

Protocol documents:
Clinical trial NCT00364013
Conditions: Metastatic Colorectal Cancer
Keywords: Oncology Cancer metastatic colorectal cancer EGFr Panitumumab Clinical Trail Amgen
Sponsor: Amgen
Start date: 2006-08-01; Completion date: 2013-03-22
Enrollment: 1183 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the treatment effect of panitumumab in combination with FOLFOX compared to FOLFOX alone as first line therapy for metastatic colorectal cancer

Detailed description:

Arms: arm 1: Participants received panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity. arm 2: Participants received FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity.
Interventions: intervention 1: Panitumumab intervention 2: FOLFOX regimen
Intervention descriptions: intervention 1: Panitumumab 6 mg/kg over on Day 1 of each 14-day cycle, just prior to the administration of chemotherapy. intervention 2: The FOLFOX regimen consisted of oxaliplatin 85 mg/m\^2 intravenous (IV) infusion on Day 1, leucovorin, 200 mg/m\^2 (racemate) on Days 1 and 2 and 5-fluorouracil 400 mg/m\^2 IV bolus followed by 600 mg/m\^2 IV infusion over 22 hours on Days 1 and 2. Each cycle was 14 days.

Protocol documents:
Clinical trial NCT01177384
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 diabetes mellitus T2DM
Sponsor: Merck Sharp & Dohme LLC
Start date: 2011-01-25; Completion date: 2013-03-25
Enrollment: 380 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate whether the addition of sitagliptin reduces hemoglobin A1C (A1C) more than the addition of placebo for participants with type 2 diabetes mellitus (T2DM) on a steady dose of acarbose. The primary hypothesis is that the addition of sitagliptin 100 mg once daily (q.d.) reduces A1C more than the addition of placebo in participants with T2DM with inadequate glycemic control on acarbose monotherapy.

Detailed description:
The study includes an 8-week antihyperglycemic agent (AHA) wash-off period\* (which includes a 2-week single-blind placebo run-in period) followed by a 24-week double-blind treatment period. All participants will receive open-label acarbose at a minimum dose of 50 mg three times daily (t.i.d.) during the run-in and treatment periods.

\*: Wash-off only applicable to patients who were on acarbose and another AHA.

Arms: arm 1: Sitagliptin 100 mg daily (q.d.) + acarbose (continuing the current stable dose of at least 50 mg three times daily \[t.i.d.\]) arm 2: Placebo q.d. + acarbose (continuing the current stable dose of at least 50 mg t.i.d.)
Interventions: intervention 1: Sitagliptin phosphate intervention 2: Comparator: Placebo intervention 3: Acarbose intervention 4: Glimepiride
Intervention descriptions: intervention 1: Sitagliptin, 100 mg tablet once daily, orally for 24 weeks intervention 2: Placebo, to match sitagliptin tablet, once daily, orally for 24 weeks intervention 3: Acarbose 50 mg or 100 mg tablet, 3 times daily, orally (continuing on the stable dose established prior to screening) for 24 weeks intervention 4: Participants not meeting specific glycemic goals during the study will use glimepiride as rescue therapy. For countries where glimepiride is not available, participants will receive a sulfonylurea marketed in that country as rescue therapy.

Protocol documents:
Clinical trial NCT01430559
Conditions: Osteoarthritis of the Knee
Keywords: Validation of the WOMAC in Chinese subjects with osteoarthritis of the knee
Sponsor: Pfizer
Start date: 2011-10-24; Completion date: 2013-03-27
Enrollment: 408 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is to validate the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) tool in mainland Chinese patients with osteoarthritis of the knee . This study will also evaluate the effects of Mobic versus placebo on reducing the symptoms of osteoarthritis in this population.

Detailed description:
To validate culturally the WOMAC tool in mainland China and observe the different response of meloxicam and placebo in a patient population with osteoarthritis of the knee

Arms: arm 1: None arm 2: 2 Placebo capsules once a day for 12 weeks
Interventions: intervention 1: Meloxicam intervention 2: Placebo
Intervention descriptions: intervention 1: 7.5mg x2 once a day for 12 weeks intervention 2: Study subjects will be randomized to two treatment groups: one with Meloxicam 7.5 mgx2 once a day and another one with placebo. The duration of the interventional treatment is 12 weeks.

Protocol documents:
Clinical trial NCT01572740
Conditions: Diabetes Diabetes Mellitus, Type 2
Sponsor: Novo Nordisk A/S
Start date: 2012-04-05; Completion date: 2013-03-27
Enrollment: 257 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted in Asia. The purpose of the trial is to investigate the efficacy and safety of liraglutide in combination with insulin therapy compared to insulin alone in Japanese subjects with type 2 diabetes mellitus. Subjects will remain on their pre-trial insulin therapy.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: liraglutide intervention 2: placebo intervention 3: insulin
Intervention descriptions: intervention 1: Liraglutide administered subcutaneously (s.c., under the skin) for 36 weeks combined with insulin therapy. intervention 2: Liraglutide placebo administered subcutaneously (s.c., under the skin) for 36 weeks combined with insulin therapy. intervention 3: All subjects will continue their pre-trial insulin therapy (basal, premixed or basal-bolus regimen) during the trial. Insulin dose is fixed for the first 16 weeks and for the subsequent 20 weeks, insulin dose is individually adjusted.

Protocol documents:
Clinical trial NCT01688739
Conditions: Migraine
Keywords: Migraine
Sponsor: Amgen
Start date: 2012-03-13; Completion date: 2013-03-27
Enrollment: 61 participants; Allocation: RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
The primary purpose of this study is to determine whether erenumab is safe and well tolerated in healthy adults and migraine patients. As part of the secondary objectives, this study will be conducted to characterize the pharmacokinetic (PK) profile of erenumab after single subcutaneous (SC) or intravenous (IV) doses in healthy participants and migraine patients as well as to characterize the effect of erenumab on the capsaicin-induced increase in dermal blood flow after single SC or IV doses in healthy participants and migraine patients.

Detailed description:
This study was a single-dose, double-blind, placebo-controlled, sequential dose escalation study in which participants were to be enrolled into 8 cohorts.

In Part 1 healthy participants were randomized in a 3:1 ratio (erenumab:placebo) into 6 cohorts: 5 cohorts received the investigational product (IP) as an SC administration and 1 cohort received it as an IV administration. In Part 2 a total of 12 migraine patients were randomized in a 1:1 ratio (erenumab:placebo) in cohort 7. An additional 8 migraine patients could have been enrolled and randomized in a 3:1 ratio in the optional cohort 8, however this cohort was not enrolled.

Arms: arm 1: Participants received a single dose of erenumab by subcutaneous injection at doses of 1 mg, 7 mg, 21 mg, 70 mg, 140 mg, and 210 mg or by IV injection at a dose of 140 mg. arm 2: Participants received a single dose of matching placebo administered by SC or IV injection.
Interventions: intervention 1: Erenumab intervention 2: Placebo
Intervention descriptions: intervention 1: Administered by subcutaneous injection or intravenous injection intervention 2: Administered by subcutaneous injection or intravenous injection

Protocol documents:
Clinical trial NCT00412893
Conditions: Aspergillosis Invasive Fungal Infection
Keywords: Invasive fungal disease BAL8557 Isavuconazole ASP9766 Filamentous fungi Phase III Aspergillus species
Sponsor: Astellas Pharma Inc
Start date: 2007-03-07; Completion date: 2013-03-28
Enrollment: 527 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the efficacy and safety of isavuconazole versus voriconazole in the treatment of patients with invasive aspergillosis.

Detailed description:
Acute invasive fungal infections caused by aspergillus, zygomycetes and other filamentous fungi remain life threatening diseases. Early treatment with highly effective anti-fungals reduces mortality. This study investigates the efficacy and safety of isavuconazole in the treatment of invasive fungal diseases, caused by Aspergillus or other filamentous fungi.

Arms: arm 1: Participants received a loading dose of isavuconazole, 200 mg three times a day by intravenous infusion (IV) for the first 2 days followed by a maintenance dose from Day 3 of 200 mg once daily either IV or orally until they reached a treatment endpoint or for a maximum of 84 days. arm 2: Participants received a loading dose of voriconazole, 6 mg/kg every 12 hours IV for the first 24 hours, followed by a maintenance dose of 4 mg/kg every 12 hours by IV on Day 2. Beginning on Day 3, participants received 4 mg/kg every 12 hours by IV or 200 mg every 12 hours orally, until they reached a treatment endpoint or for a maximum of 84 days.
Interventions: intervention 1: Isavuconazole intervention 2: Voriconazole
Intervention descriptions: intervention 1: Loading doses were administered as IV infusion and maintenance doses were administered as IV infusion or oral (capsules). intervention 2: Loading doses were administered as IV infusion and maintenance doses were administered as IV infusion or oral (capsules).

Protocol documents:
Clinical trial NCT01405560
Conditions: Hepatitis C, Chronic
Sponsor: Merck Sharp & Dohme LLC
Start date: 2011-09-02; Completion date: 2013-03-29
Enrollment: 42 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the safety, tolerability, and efficacy of vaniprevir (300 mg twice daily) given in combination with pegylated interferon alfa-2b (peg-IFN) and ribavirin (RBV) in Japanese participants with chronic hepatitis C (CHC) genotype (GT) 1 who have not responded to previous treatment. The primary efficacy objective is to estimate efficacy of vaniprevir, peg-IFN and RBV for 24 weeks as assessed by the percentage of participants achieving undetectable Hepatitis C Virus ribonucleic acid (HCV RNA) 24 weeks after completion of all study therapy (Sustained Viral Response 24 \[SVR24\]).

Detailed description:

Arms: arm 1: Participants receive 24 weeks of vaniprevir (300 mg twice daily) with concomitant peg-IFN and RBV treatment
Interventions: intervention 1: Vaniprevir intervention 2: peg-IFN intervention 3: ribavirin
Intervention descriptions: intervention 1: Capsules containing 150 mg vaniprevir, orally, two in the morning and two in the evening for 24 weeks intervention 2: Open-label peg-IFN alfa-2b at 1.5 μg/kg once per week, administered subcutaneously (SC) for 24 weeks intervention 3: Capsules containing 200 mg RBV, orally, 3 to 5 capsules, dosage based on the participant's weight (600 mg/day to 1000 mg/day), for 24 weeks

Protocol documents:
Clinical trial NCT01527110
Conditions: Influenza, Human
Keywords: zanamivir Seasonal Influenza H1N1 intravenous neuraminidase inhibitor Pandemic Relenza Influenza B virus Influenza A virus
Sponsor: GlaxoSmithKline
Start date: 2012-01-01; Completion date: 2013-03-29
Enrollment: 21 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will be an open-label, multi-center, single arm study to evaluate the safety and efficacy of IV zanamivir 600mg twice daily for 5 days in hospitalized subjects with laboratory confirmed influenza infection.

Detailed description:
Adult subjects and adolescent subjects (≥50 kg) with normal renal function will receive 600mg per dose. Subjects with renal impairment will receive an adjusted dose based on calculated creatinine clearance. The initial 5 day treatment course may be extended for up to 5 additional days if viral shedding is determined to be ongoing or if clinical symptoms warrant further treatment with IV zanamivir.

The study duration is approximately 28 days for subjects whose treatment duration is 5 days, and up to approximately 33 days for subjects whose treatment duration is extended to a maximum of 10 days. The study will consist of Pre-dose Baseline Assessments (Day 1), During Treatment Assessments (Days 1 to 5, and up to Day 10), and Follow-up Assessments on the following days: Post-Treatment +2, +5, +9, +16 and +23 Days. For subjects who have been discharged from hospital, the Post-Treatment +2, +5, +9 and +16 Days Assessments can be made by telephone contact.

Arms: arm 1: 600mg of IV zanamivir infusion twice daily
Interventions: intervention 1: Intravenous (IV) zanamivir
Intervention descriptions: intervention 1: Zanamivir aqueous solution 10mg/mL, 600mg of IV zanamivir infusion twice daily for 5 days

Protocol documents:
Clinical trial NCT01333111
Conditions: Congenital Bleeding Disorder Haemophilia B
Sponsor: Novo Nordisk A/S
Start date: 2011-04-27; Completion date: 2013-03-31
Enrollment: 74 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted in Africa, Asia, Europe, Japan and North America. The aim of this trial is to evaluate the safety and efficacy, including pharmacokinetics (the rate at which the body eliminates the trial drug), of NNC-0156-0000-0009 (nonacog beta pegol) when used for treatment and prophylaxis of bleeding episodes in patients with haemophilia B.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: nonacog beta pegol intervention 2: nonacog beta pegol intervention 3: nonacog beta pegol
Intervention descriptions: intervention 1: One single dose administered intravenously (into the vein) once weekly. Patients will receive instruction on how to treat any bleeding episode they may experience intervention 2: One single dose administered intravenously (into the vein) once weekly. Patients will receive instruction on how to treat any bleeding episode they may experience intervention 3: Patients will treat themselves with either a low or a high dose dependent on the severity of the bleeding episode

Protocol documents:
Clinical trial NCT00720798
Conditions: Rheumatoid Arthritis
Sponsor: Hoffmann-La Roche
Start date: 2005-09-01; Completion date: 2013-04-01
Enrollment: 2067 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This single-arm study evaluated the long-term efficacy and safety of tocilizumab in participants who had completed treatment in the tocilizumab core studies (NCT00106522 \[Roche protocol WA18062\], NCT00106574 \[Roche protocol WA18063\], and NCT00109408 \[Roche protocol WA17824\]) of adults with rheumatoid arthritis. Participants received tocilizumab alone or in combination with standard anti-rheumatic treatment.

Detailed description:

Arms: arm 1: Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
Interventions: intervention 1: Tocilizumab intervention 2: Disease-modifying anti-rheumatic drugs intervention 3: Non-steroidal anti-inflammatory drugs intervention 4: Oral corticosteroids
Intervention descriptions: intervention 1: For participants weighing \> 100 kg, the maximum dose of tocilizumab was 800 mg. Tocilizumab was supplied as a sterile solution in vials. intervention 2: Disease-modifying anti-rheumatic drugs included methotrexate, chloroquine, hydroxychloroquine, parenteral gold, sulfasalazine, azathioprine, and leflunomide. These drugs could be used alone or in combination, except for the combination of methotrexate and leflunomide, which was not allowed. intervention 3: Participants could be treated with non-steroidal anti-inflammatory drugs up to the maximum recommended dose throughout the study. The choice and doses of non-steroidal anti-inflammatory drugs were at the discretion of the investigator. intervention 4: Oral corticosteroids (≤ 10 mg/day) were permitted during the study.

Protocol documents:
Clinical trial NCT00838903
Conditions: Diabetes Mellitus, Type 2
Keywords: diabetes
Sponsor: GlaxoSmithKline
Start date: 2009-02-01; Completion date: 2013-04-01
Enrollment: 1049 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if albiglutide is safe and effective in the treatment of type 2 diabetes.

Detailed description:

Arms: arm 1: Albiglutide + metformin + placebo sitagliptin + placebo glimepiride arm 2: Sitagliptin + metformin + placebo albiglutide + placebo glimepiride arm 3: Glimepiride + metformin + placebo albiglutide + placebo sitagliptin arm 4: Metformin + placebo albiglutide + placebo sitagliptin + placebo glimepiride
Interventions: intervention 1: albiglutide intervention 2: sitagliptin intervention 3: glimepiride intervention 4: metformin intervention 5: placebo albiglutide intervention 6: placebo sitagliptin intervention 7: placebo glimepiride
Intervention descriptions: intervention 1: albiglutide intervention 2: sitagliptin intervention 3: Glimepiride intervention 4: Metformin intervention 5: placebo to match albiglutide intervention 6: placebo to match sitagliptin intervention 7: placebo to match glimepiride

Protocol documents:
Clinical trial NCT00839527
Conditions: Diabetes Mellitus, Type 2
Keywords: diabetes
Sponsor: GlaxoSmithKline
Start date: 2009-02-01; Completion date: 2013-04-01
Enrollment: 685 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the safety and efficacy of albiglutide in subjects with type 2 diabetes

Detailed description:

Arms: arm 1: Metformin + glimepiride + pioglitazone + matching albiglutide placebo arm 2: Metformin + open-label glimepiride + pioglitazone matching placebo + albiglutide arm 3: metformin + open-label glimepiride + pioglitazone placebo + albiglutide placebo
Interventions: intervention 1: placebo to match albiglutide intervention 2: albiglutide intervention 3: metformin intervention 4: glimepiride intervention 5: pioglitazone intervention 6: placebo to match pioglitazone
Intervention descriptions: intervention 1: albiglutide matching placebo weekly subcutaneous injection intervention 2: albiglutide weekly subcutaneous injection intervention 3: metformin intervention 4: glimepiride intervention 5: pioglitazone intervention 6: pioglitazone matching placebo

Protocol documents:
Clinical trial NCT00986154
Conditions: Venous Thromboembolism Deep Vein Thrombosis (DVT) Pulmonary Embolism (PE) Thromboembolism Venous Thrombosis
Keywords: Recurrent Thrombosis Recurrent Pulmonary Embolism Symptomatic Deep Vein Thrombosis Symptomatic Pulmonary Embolism Venous Thromboembolism (VTE)
Sponsor: Daiichi Sankyo
Start date: 2009-10-01; Completion date: 2013-04-01
Enrollment: 8292 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Evaluation of heparin/edoxaban tosylate (DU176b) versus heparin/warfarin in preventing recurrence of blood clots in patients with acute symptomatic deep-vein blood clots in the legs and/or blood clots in the lungs.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: edoxaban tosylate(DU-176b) intervention 2: low molecular weight heparin/unfractionated heparin intervention 3: warfarin
Intervention descriptions: intervention 1: edoxaban tosylate(DU-176b), film-coated tablet for oral use, 30 mg, two tablets (60 mg) once daily, maximum of 12 months treatment intervention 2: LMW heparin - subcutaneous injection, 1 mg/Kg twice daily or 1.5 mg/Kg once daily.

Unfractionated heparin - 5,000 IU bolus intravenous administration, 1,300 IU/hour continuous infusion, minimum of 5 days and maximum of about 12 days treatment intervention 3: tablet for oral use; 0.5 mg, 1 mg, 2.5 mg, 5 mg; daily dosage, adjusted to maintain international normalized ratio (INR) between 2.0 and 3.0; maximum of 12 months treatment

Protocol documents: