ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00848120
Conditions: Rheumatoid Arthritis
Sponsor: Hoffmann-La Roche
Start date: 2008-12-31; Completion date: 2010-02-13
Enrollment: 29 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This single arm, open label study will assess the safety and efficacy, with regard to reduction of signs and symptoms,of treatment with tocilizumab in patients with moderate to severe active rheumatoid arthritis. Patients will receive tocilizumab 8 mg/kg IV every 4 weeks for a total of 6 infusions. Patients already receiving methotrexate at entry into the study may continue with their treatment together with tocilizumab.The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.

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 NCT00561574
Conditions: Sleep Initiation and Maintenance Disorder; Elderly Mental Disorder Dyssomnias Sleep Disorders Sleep Disorder, Intrinsic
Keywords: elderly randomized double blind
Sponsor: Merck Sharp & Dohme LLC
Start date: 2008-01-09; Completion date: 2010-02-14
Enrollment: 259 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The current study is a 52-week safety study in elderly outpatients with chronic primary insomnia randomized to treatment with 1.5 mg or 3.0 mg of esmirtazapine (Org 50081, SCH 900265, MK-8265) to investigate the safety and tolerability of long-term treatment with esmirtazapine in elderly patients.

Detailed description:
Insomnia is a common complaint or disorder throughout the world. About one third of the population in the industrial countries reports difficulty initiating or maintaining sleep, resulting in a non-refreshing or non-restorative sleep. The majority of the insomniacs suffer chronically from their complaints.

The maleic acid salt of Org 4420, code name Org 50081 (esmirtazapine), was selected for development in the treatment of insomnia. The first clinical trial with esmirtazapine was a proof-of-concept trial with a four-way cross-over design. All 3 esmirtazapine dose groups showed a statistically significant positive effect on Total Sleep Time (TST) (objective and subjective) and Wake Time After Sleep Onset (WASO), as compared to placebo.

The current study is a 52-week safety study in elderly outpatients with chronic primary insomnia randomized to treatment with 1.5 mg or 3.0 mg of esmirtazapine to investigate the safety and tolerability of long-term treatment with esmirtazapine in elderly patients.

Arms: arm 1: Participants receive esmirtazapine 1.5 mg tablets, one tablet administered orally once daily for up to 52 weeks arm 2: Participants receive esmirtazapine 3.0 mg tablets, one tablet administered orally once daily for up to 52 weeks
Interventions: intervention 1: Esmirtazapine
Intervention descriptions: intervention 1: One tablet daily

Protocol documents:
Clinical trial NCT01038427
Conditions: Rhinitis, Allergic, Seasonal
Keywords: Rhinitis Seasonal Allergic Rhinitis Mometasone Furoate Equivalence Hay fever
Sponsor: Sandoz
Start date: 2009-12-02; Completion date: 2010-02-16
Enrollment: 795 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study compared the efficacy and safety of a generic mometasone nasal spray to the reference listed drug in the treatment of seasonal allergic rhinitis. Additionally both the test and the reference formulations were tested for superiority against a placebo nasal spray.

Detailed description:
The study was designed as a double-blind, randomized, placebo-controlled, parallel group, multi-site to compare the clinical equivalence of the test formulation of mometasone furoate monohydrate, 50 mcg/actuation nasal spray (Lek Pharmaceuticals d.d.) with the reference formulation Nasonex® nasal spray (Schering) in the relief of the signs and symptoms of seasonal allergic rhinitis. Participants who met the inclusion/exclusion criteria entered a 7-day placebo lead-in period. Following this placebo lead-in period, on Day 1 participants who continued to meet eligibility criteria were randomly assigned in a 2:2:1 ratio to one of three treatment groups (Test Product:Reference Product:Placebo) for 14 days of treatment. In all treatment groups, participants were instructed to administer the study drug once daily at approximately the same time each day. A single dose of 200 mcg was 4 actuations, each containing 50 mcg per actuation. Patients were instructed to administer the 4 actuations alternating between right and left nostril, such that 2 actuations were not administered back to back to the same nostril.

Arms: arm 1: Mometasone furoate 50 mcg/actuation nasal spray (Lek Pharmaceuticals) administered once daily at a dose of 200 mcg (4 actuations) for 14 days. arm 2: Mometasone furoate (Nasonex®) 50 mcg/actuation nasal spray administered once daily at a dose of 200 mcg (4 actuations) for 14 days. arm 3: Placebo nasal spray administered once daily for 14 days.
Interventions: intervention 1: Mometasone furoate 50 mcg/actuation nasal spray (Lek Pharmaceuticals) intervention 2: Mometasone furoate (Nasonex®) 50 mcg/actuation nasal spray intervention 3: Placebo
Intervention descriptions: intervention 1: Mometasone nasal spray administered once daily at a dose of 200 mcg (4 actuations) for 14 days. intervention 2: Mometasone nasal spray administered once daily at a dose of 200 mcg (4 actuations) for 14 days. intervention 3: Placebo nasal spray administered once daily (4 actuations) for 14 days.

Protocol documents:
Clinical trial NCT00759785
Conditions: Breast Cancer
Sponsor: Merck Sharp & Dohme LLC
Start date: 2008-09-30; Completion date: 2010-02-17
Enrollment: 48 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A study to evaluate the response of growth factor signatures (GFS) to a single dose of dalotuzumab in participants with triple negative (TN) or estrogen receptor (ER)-positive luminal B breast cancer. The primary hypothesis is that dalotuzumab will induce a decrease in the GFS in at least 40% of participants.

Detailed description:

Arms: arm 1: Single dose of dalotuzumab 20 mg/kg infused intravenously over 60-120 minutes. arm 2: Single dose of dalotuzumab 20 mg/kg infused intravenously over 60-120 minutes.
Interventions: intervention 1: dalotuzumab (MK0646)
Intervention descriptions: intervention 1: Single intravenous infusion

Protocol documents:
Clinical trial NCT00926185
Conditions: Dry Eye
Keywords: Dry Eye ophthalmic delivery
Sponsor: Shire
Start date: 2009-08-03; Completion date: 2010-02-18
Enrollment: 230 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy of three different concentrations (0.1%, 1.0%, 5.0%) of SAR 1118 Ophthalmic Solution compared to placebo in the treatment of dry eye.

Detailed description:

Arms: arm 1: Placebo Ophthalmic Solution arm 2: Lifitegrast arm 3: Lifitegrast arm 4: Lifitegrast
Interventions: intervention 1: Lifitegrast intervention 2: Placebo
Intervention descriptions: intervention 1: Ophthalmic Solution intervention 2: Ophthalmic Solution

Protocol documents:
Clinical trial NCT00765856
Conditions: Chronic Pain
Keywords: Opioid tolerant Pediatric Male 6-17 years of age Female 6-17 years of age Pain Non malignant Malignant
Sponsor: Endo Pharmaceuticals
Start date: 2008-11-17; Completion date: 2010-02-22
Enrollment: 27 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Patients will convert from current opioid to Oxymorphone ER and undergo titration. During the Titration Period, subjects will receive daily oxymorphone Extended Release tablets(s) every 12 hours. Dosing adjustments will be based on the review of the subject's pain scores. Oxymorphone IR 5 mg will be provided to be used as supplemental "breakthrough" pain medication (as needed). Titration Period will end when the fixed dose of study medication is tolerated and the subject achieves adequate analgesia. Subjects will then proceed to the open-label 3-month maintenance period on the fixed dose of study medication established during the Titration Period.

Detailed description:
An Open-Label Safety and Tolerability Study of Immediate-Release and Extended-Release Oxymorphone in Opioid-Tolerant Pediatric Subjects With Chronic Pain.

Arms: arm 1: None
Interventions: intervention 1: Oxymorphone ER
Intervention descriptions: intervention 1: Oxymorphone ER dosing adjustments made under the direction of the Investigator during the Titration Period.

Oxymorphone IR (Opana) IR 5mg tablet - used as rescue medications

Protocol documents:
Clinical trial NCT00941603
Conditions: Primary Hypercholesterolemia Mixed Hyperlipidemia
Sponsor: Merck Sharp & Dohme LLC
Start date: 2009-06-29; Completion date: 2010-02-22
Enrollment: 619 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the effect of SCH 900271 compared to placebo on the reduction of low-density lipoprotein cholesterol (LDL-C) from baseline to 8 weeks of treatment in participants with primary hypercholesterolemia (familial and nonfamilial) or mixed hyperlipidemia. The study will also evaluate the effect of SCH 900271 on non-high density lipoprotein cholesterol (non-HDL-C) and various other lipids and lipoproteins. The safety of SCH 900271 in this participant population will also be evaluated.

Detailed description:

Arms: arm 1: Participants receive SCH 900271 15 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks arm 2: Participants receive SCH 900271 10 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks arm 3: Participants receive SCH 900271 5 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks arm 4: Participants receive SCH 900271 2.5 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks arm 5: Participants receive SCH 900271 1 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks arm 6: Participants receive two placebo tablets once daily in the morning with water in a fasted state for 8 weeks
Interventions: intervention 1: SCH 900271 15mg intervention 2: SCH 900271 intervention 3: SCH 900271 intervention 4: SCH 900271 intervention 5: SCH 900271 intervention 6: Placebo
Intervention descriptions: intervention 1: oral tablets; SCH 900271 - 15 mg taken once daily for 8 weeks intervention 2: oral tablets; SCH 900271 10 mg taken once daily for 8 weeks intervention 3: oral tablets; SCH 900271- 5 mg taken once daily for 8 weeks intervention 4: oral tablets; SCH 900271- 2.5 mg taken once daily for 8 weeks intervention 5: oral tablets; SCH 900271- 1 mg taken once daily for 8 weeks intervention 6: oral tablets; placebo administered once daily during the 5-week single-blind placebo run-in and diet stabilization period and during the 8 week double-blind treatment period.

Protocol documents:
Clinical trial NCT00797225
Conditions: Endometriosis
Keywords: bone mineral density,endometriosis,pelvic pain
Sponsor: AbbVie
Start date: 2008-11-26; Completion date: 2010-02-24
Enrollment: 174 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to evaluate the safety and beneficial effects of elagolix (NBI-56418) compared to placebo and leuprorelin (an approved endometriosis therapy) over a three month period followed by an additional three months of treatment on elagolix.

Detailed description:
The study followed a parallel-group design in which participants were randomized (1:1:1:1) to one of the following treatment groups for the first 12 weeks of dosing: 150 mg elagolix once daily (q.d.); 250 mg elagolix q.d.; placebo; or leuprorelin acetate depot injection 3.75 mg (monthly). Blinding was achieved using a double-dummy design. Following 12 weeks of dosing, participants continued in the study for an additional 12 weeks; participants randomized to elagolix continued to receive their assigned dose and participants randomized to placebo or leuprorelin acetate were re-randomized to receive one of the two doses of elagolix (150 mg q.d. or 250 mg q.d.) for 12 weeks in a double-blind fashion. Six weeks after the last dose of the study drug at the end of Week 24, a follow-up visit was performed (end of Week 30).

There was no pre-specified primary efficacy end point as there was no single key efficacy outcome measure in this exploratory Phase 2 study. For purposes of results reported here, Change From Baseline in the Monthly Mean Numerical Rating Score (NRS) for Endometriosis Pain is designated as the primary outcome measure.

Arms: arm 1: Participants received placebo tablets once a day and placebo intramuscular injection once a month for 12 weeks. At the end of 12 weeks participants were re-randomized to receive one of the two doses of elagolix (150 mg or 250 mg) for 12 weeks. arm 2: Participants received elagolix 150 mg tablets once a day and placebo intramuscular injection once a month for 12 weeks. At the end of 12 weeks participants continued to receive elagolix 150 mg for an additional 12 weeks. arm 3: Participants received elagolix 250 mg tablets once a day and placebo intramuscular injection once a month for 12 weeks. At the end of 12 weeks participants continued to receive elagolix 250 mg for an additional 12 weeks. arm 4: Participants received placebo tablets once a day and leuprorelin acetate 1-month depot 3.75 mg intramuscular injection once a month for 12 weeks. At the end of 12 weeks participants were re-randomized to receive one of the two doses of elagolix (150 mg or 250 mg) for 12 weeks.
Interventions: intervention 1: Leuprorelin Acetate Depot intervention 2: Elagolix intervention 3: Placebo to Elagolix intervention 4: Placebo to Leuprorelin Acetate
Intervention descriptions: intervention 1: Leuprorelin acetate depot injection 3.75 mg administered as an intramuscular injection intervention 2: Elagolix tablets administered orally intervention 3: Placebo tablet administered orally intervention 4: Saline solution administered as an intramuscular injection

Protocol documents:
Clinical trial NCT00999336
Conditions: Renal Impairment
Keywords: Betrixaban Renal impairment Healthy Kidney dysfunction
Sponsor: Portola Pharmaceuticals
Start date: 2009-07-31; Completion date: 2010-02-28
Enrollment: 32 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to compare the pharmacokinetics, pharmacodynamics, and tolerability of betrixaban in patients with mild, moderate, and severe renal impairment to healthy volunteers.

Detailed description:

Arms: arm 1: Healthy subjects matched to the renal impairment groups arm 2: Patients with mild renal impairment arm 3: Patients with moderate renal impairment arm 4: Patients with severe renal impairment
Interventions: intervention 1: Betrixaban
Intervention descriptions: intervention 1: 80 mg betrixaban qd for 8 days

Protocol documents:
Clinical trial NCT01024608
Conditions: Seasonal Allergic Rhinitis Hay Fever
Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Start date: 2009-12-31; Completion date: 2010-02-28
Enrollment: 340 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to assess the efficacy and safety of an investigational nasal aerosol compared with placebo nasal aerosol in the treatment of seasonal allergic rhinitis.

Detailed description:

Arms: arm 1: During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily each morning. arm 2: During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning.
Interventions: intervention 1: Beclomethasone dipropionate intervention 2: Placebo Nasal Aerosol
Intervention descriptions: intervention 1: Total daily dose of 320 micrograms per day of beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) applied as a nasal aerosol each morning for two weeks. intervention 2: Placebo nasal aerosol administered each morning for two weeks.

Protocol documents:
Clinical trial NCT00084266
Conditions: Methicillin Resistant Staphylococcus Aureus (MRSA)
Keywords: Staphylococcal pneumonia Methicillin-resistant staphylococcal pneumonia healthcare-associated pneumonia
Sponsor: Pfizer
Start date: 2004-10-01; Completion date: 2010-03-01
Enrollment: 1225 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To determine if linezolid is superior to vancomycin in the treatment of nosocomial (acquired in the hospital) pneumonia due to Methicillin Resistant Staphylococcus Aureus (MRSA) in adult subjects. Subjects entered in to the study will have proven healthcare-associated methicillin-resistant Staphylococcus aureus pneumonia which will be treated with either linezolid or vancomycin.

Detailed description:

Arms: arm 1: Subjects receiving linezolid for the treatment phase of the study arm 2: Subjects receiving vancomycin for the treatment phase of the study
Interventions: intervention 1: linezolid (Zyvox) intervention 2: vancomycin
Intervention descriptions: intervention 1: Subjects to receive either linezolid 600 mg IV (Intravenous) or PO (orally) q 12 h (every 12 hours) for 7-14 days, except in cases of documented bacteremia where it could be extended to 21 days based upon investigator's discretion. intervention 2: Subjects to receive vancomycin 15mg/kg IV (Intravenous) q12h (every 12 hours), adjusted for renal function, for 7-14 days, except in cases of documented bacteremia where it could be extended to 21 days based upon investigator's discretion.

Protocol documents:
Clinical trial NCT00377637
Conditions: Lupus Nephritis
Sponsor: Hoffmann-La Roche
Start date: 2005-07-01; Completion date: 2010-03-01
Enrollment: 370 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This 2 arm study assessed the efficacy of Mycophenolate Mofetil (MMF; CellCept) compared to cyclophosphamide in inducing a response in patients with lupus nephritis, and the long term efficacy of MMF compared to azathioprine in maintaining remission and renal function. Patients were randomized to receive either MMF (1.5 g twice daily \[bid\]) or cyclophosphamide (0.5-1.0 g/m\^2 in monthly pulses) in the induction phase. Those patients meeting criteria for response were re-randomized for entry into the maintenance phase, to receive either MMF (1 g bid) or azathioprine (2 mg/kg/day).

Detailed description:

Arms: arm 1: Participants received oral mycophenolate mofetil (MMF) 1.5 g twice a day and concomitant corticosteroids for the 24 weeks of the Induction Phase. arm 2: Participants received monthly infusions of cyclophosphamide, 0.5 to 1.0 g per square meter of body surface area and concomitant treatment with corticosteroids for the 24 week Induction Phase. arm 3: Participants received mycophenolate mofetil (MMF) 1.0 g orally twice a day, placebo to azathioprine orally once a day and corticosteroid for the 36 weeks Maintenance Phase. arm 4: Participants received azathioprine (AZA) 2 mg/kg/day orally once a day, placebo to mycophenolate mofetil orally twice a day and corticosteroid for the 36 weeks Maintenance Phase.
Interventions: intervention 1: Mycophenolate mofetil (MMF) intervention 2: Cyclophosphamide intervention 3: Azathioprine intervention 4: Placebo to Azathioprine intervention 5: Placebo to Mycophenolate mofetil intervention 6: Corticosteroid
Intervention descriptions: intervention 1: Supplied as 500 mg tablets taken orally twice a day (BID). Dose specific for each arm. Dosing started at 500 mg BID for the first week, increasing by 500 mg in subsequent weeks until the final target dose was reached. intervention 2: Intravenous cyclophosphamide (IVC) was administered every four weeks (monthly) to a total of six infusions.

Dosing was started at 0.75 g/m\^2 of body surface area for the first month, with subsequent doses at 0.5-1.0 g/m\^2. The target dose was 1.0 g/m\^2, but doses were titrated by 0.25 g/m\^2 increments to maintain nadir leukocyte count between 2500-4000/mm\^3. intervention 3: 2 mg/kg/day orally, provided as 50 mg capsules to be taken after meals. intervention 4: Placebo capsules matching Azathioprine taken orally once a day. intervention 5: Placebo tablets matching Mycophenolate mofetil taken orally twice daily. intervention 6: Oral prednisolone (or equivalent) starting at a dose of 0.75-1.0 mg/kg/day (maximum 60 mg/day) tapered to 10 mg/day.

Protocol documents:
Clinical trial NCT00384085
Conditions: Diabetes Mellitus, Type 2
Sponsor: Sanofi
Start date: 2006-05-01; Completion date: 2010-03-01
Enrollment: 588 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objectives were:

* To demonstrate the superiority of Lantus plus stepwise addition of mealtime Apidra® (Lantus/Apidra-3) versus twice-daily Premixed insulin based on the proportion of patients achieving target glycemic control (as measured by hemoglobin A1c \[HbA1c\] \<7.0%) at Week 60
* To demonstrate the noninferiority of Lantus plus addition of 1 mealtime Apidra injection (Lantus/Apidra-1) versus twice-daily Premixed insulin based on the reduction from Baseline to Week 60 in HbA1c

Detailed description:

Arms: arm 1: Insulin glargine (Lantus) plus up to 3 injections of insulin glulisine (Apidra) added to oral agents. arm 2: Insulin glargine (Lantus) plus up to 1 injection of insulin glulisine (Apidra) added to oral agents. arm 3: Premixed insulin (Novolog® Mix 70/30) added to oral agents.
Interventions: intervention 1: Insulin Glulisine intervention 2: Insulin Glargine intervention 3: Premixed Insulin intervention 4: Insulin Glulisine
Intervention descriptions: intervention 1: Subcutaneous injection up to 1 injection per day intervention 2: Subcutaneous injection once-a-day intervention 3: Subcutaneous injection twice-a-day. intervention 4: Subcutaneous injection up to 3 injections per day.

Protocol documents: