ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00478023
Conditions: Hysterectomy Postoperative
Keywords: Opioid Central acting analgesic Pain postoperative Abdomen acute CG5503 IR Morphine Placebo
Sponsor: Grünenthal GmbH
Start date: 2007-05-01; Completion date: 2008-04-01
Enrollment: 854 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main objective of this study is to demonstrate the efficacy and safety of multiple-dose application of three different oral doses of CG5503 IR (tapentadol immediate release) compared to placebo in women undergoing abdominal hysterectomy.

Detailed description:
Subjects undergoing abdominal hysterectomy often experience moderate to severe acute pain post-surgery. Normally such pain is controlled when subjects receive repeated doses of opioid analgesics. However, opioid therapy is commonly associated with side effects such as nausea, vomiting, sedation, constipation, addiction, tolerance, and respiratory depression. Tapentadol (CG5503), a newly synthesized drug with an immediate release (IR) formulation, also acts as a centrally acting pain reliever but has a dual mode of action. The aim of this study is to investigate the effectiveness (level of pain control) and safety (side effects) of 3 dose levels of CG5503 IR compared with no drug (placebo) or one dose level of morphine (an opioid commonly used to treat post-surgical pain). This study is a randomized, double-blind (neither investigator nor patient will know which treatment was received), active- and placebo-controlled, parallel-group, multicenter study to evaluate the treatment of acute pain after abdominal hysterectomy. The study will include a blinded 72 hour in-patient phase immediately following hysterectomy, during which subjects will be treated with either 50-, 75-, or 100-mg CG5503 IR, a matched placebo, or 20-mg morphine, and pain relief will be periodically assessed. Assessments of pain relief include the pain intensity numeric rating scale (PI), pain relief numeric rating scale (PAR), and patient global impression of change scale (PGIC). Safety evaluations include monitoring of adverse events, physical examinations, and clinical laboratory tests. Venous blood samples will be collected for the determination of serum concentrations of CG5503 and morphine. The alternative study hypothesis is that at least 1 dose strength of CG5503 will be different from placebo in controlling pain at 24 hours (using the mean SPID at 24 hours).

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None
Interventions: intervention 1: Morphine intervention 2: CG5503 IR intervention 3: CG5503 IR intervention 4: CG5503 IR intervention 5: Placebo
Intervention descriptions: intervention 1: 20 mg IR; 4 - 6 hourly; Total 72 hours intervention 2: 50mg; 4 - 6 hourly; Total 72 hours intervention 3: 75mg; 4 -6 hourly; Total 72 hours intervention 4: 100mg, 4 - 6 hourly; Total 72 hours intervention 5: 4 - 6 hourly; Total 72 hours

Protocol documents:
Clinical trial NCT00483496
Conditions: Idiopathic Solar Urticaria
Sponsor: Orfagen
Start date: 2007-09-01; Completion date: 2008-04-01
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Commercially available external photoprotectors (EP) do not provide adequate protection against ultraviolet A (UVA) and visible wavelengths. The proposed medicinal product V0096 CR (formula RV3131A-MV1166) is a broad spectrum EP (bsEP). The rationale for the use of V0096 CR (formula RV3131A-MV1166) in the proposed condition is based on its ability to broadly block the UVA radiations and visible light that are known to trigger solar urticaria (SU).

Detailed description:

Arms: arm 1: Each patient received each one of the 8 test products on their respective randomly allocated sites on grid (grid to be applied on the back skin; 1 product by grid window).

Single application of the test materials at the dosage of 2mg/cm² (total of 8 treated sites), prior to irradiation using a solar simulator.
Interventions: intervention 1: Titanium dioxide (Ti02) microfine 12.15% alone (formula RV3131A-MV1209) intervention 2: Ti02 pigmentary 3% alone (formula RV3131A-MV1211) intervention 3: bisoctrizole 10% alone (formula RV3131A-MV1237) intervention 4: Ti02 microfine 12.15% + Ti02 pigmentary 3% (formula RV3131A-MV1213) intervention 5: Ti02 microfine 12.15% + bisoctrizole 10% (formula RV3131A-MV1329) intervention 6: Ti02 pigmentary 3% + bisoctrizole 10% (formula RV3131A-MV1212) intervention 7: Ti02 microfine 12.15% + Ti02 pigmentary 3% + bisoctrizole 10% [V0096 CR (formula RV3131A-MV1166)] intervention 8: V0096 CR vehicle (formula RV3131A-MV1197)
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None intervention 6: None intervention 7: None intervention 8: None

Protocol documents:
Clinical trial NCT00486291
Conditions: Type 2 Diabetes Mellitus
Keywords: Diabetes, Obese diabetics
Sponsor: VIVUS LLC
Start date: 2007-06-01; Completion date: 2008-04-01
Enrollment: 210 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of VI-0521 compared to placebo in the glycemic management of obese diabetic adults.

Detailed description:

Arms: arm 1: Phentermine 15mg/topiramate 100mg arm 2: Matched placebo
Interventions: intervention 1: VI-0521 intervention 2: Placebo
Intervention descriptions: intervention 1: phentermine 15mg/topiramate 100mg intervention 2: matched placebo

Protocol documents:
Clinical trial NCT00487188
Conditions: HIV Infections
Sponsor: Hoffmann-La Roche
Start date: 2005-11-01; Completion date: 2008-04-01
Enrollment: 47 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To assess the efficacy of enfuvirtide (Fuzeon) added to HAART compared to treatment with HAART alone in achieving and maintaining viral load suppression.

Detailed description:
This study consisted of two phases. In the Induction phase patients were randomized at Baseline 1 (BL1) in a 1:2 ratio to receive:

* I1: HAART or
* I2: Enfuvirtide (90 mg twice a day) + HAART.

Participants who achieved viral suppression \< 50 copies/mL by week 24, confirmed by week 28 or earlier, qualified to enter the Maintenance Phase which started at Baseline 2 (BL2), four weeks after confirmation of response. The Maintenance Phase consisted of three treatment groups:

* M1: HAART continued (patients from I1)

Patients on ENF+HAART (I2) were re-randomized (at a 1:1 ratio) at BL2 to:

* M2: Enfuvirtide stopped and HAART continued
* M3: Enfuvirtide + HAART continued.

The duration of the Maintenance Phase was from BL2 up to 48 weeks after BL1. BL2 could start at the earliest at Week 12 and at the latest Week 32.

Arms: arm 1: Participants received Enfuvirtide (ENF) 90 mg administered by subcutaneous injection twice a day for up to 48 weeks in addition to an oral highly active antiretroviral treatment (HAART) regimen for up to 48 weeks. arm 2: Participants received an oral highly active antiretroviral treatment (HAART) regimen, consisting of 3-5 antivirals for up to 48 weeks.
Interventions: intervention 1: Enfuvirtide intervention 2: Highly active antiretroviral treatment (HAART)
Intervention descriptions: intervention 1: 90 mg subcutaneous injection twice a day intervention 2: An oral HAART regimen of 3-5 antiretrovirals was chosen by the physician and patient, based on the patient's prior treatment history and genotypic antiretroviral resistance testing.

Protocol documents:
Clinical trial NCT00505622
Conditions: Parkinson's Disease
Sponsor: Eisai Limited
Start date: 2007-07-01; Completion date: 2008-04-01
Enrollment: 328 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a multicentre, open-label extension study to evaluate the long-term safety, tolerability, and efficacy of Perampanel (E2007) as an adjunctive therapy in levodopa treated PD subjects with motor fluctuations. All subjects who have completed E2007-E044-213 or E2007-G000-309 will be candidates for entering this extension trial, provided that they meet the inclusion/exclusion criteria and have completed the core study, up to and including the final efficacy visit.

Detailed description:

Arms: arm 1: E2007 2 mg (one 2 mg tablet taken daily in the evening), or 4 mg (two 2 mg tablets daily in the evening).
Interventions: intervention 1: Perampanel
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00511199
Conditions: Contraception
Sponsor: Organon and Co
Start date: 2006-05-01; Completion date: 2008-04-01
Enrollment: 2152 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of this study is to assess contraceptive efficacy, vaginal bleeding patterns (cycle control), general safety and acceptability of the nomegestrol acetate-estradiol (NOMAC-E2) combined oral contraceptive (COC) in a large group of women aged 18-50 years.

Detailed description:

Arms: arm 1: Nomegestrol Acetate (NOMAC) and Estradiol (E2), 2.5 mg NOMAC and 1.5 mg E2

monophasic combined oral contraceptive arm 2: Drospirenone (DRSP) and Ethinyl Estradiol (EE), 3 mg DRSP and 30 mcg EE monophasic combined oral contraceptive
Interventions: intervention 1: NOMAC-E2 intervention 2: DRSP-EE
Intervention descriptions: intervention 1: Nomegestrol Acetate and Estradiol Tablets, 2.5 mg

NOMAC and 1.5 mg E2 taken once daily from Day 1 of menstrual period up to and including Day 28 for 13 consecutive 28-day menstrual cycles (1 year). intervention 2: Drospirenone and Ethinyl Estradiol Tablets, 3 mg DRSP and 30 mcg EE taken once daily from Day 1 of menstrual period up to and including Day 28 for 13 consecutive 28-day menstrual cycles (1 year).

Protocol documents:
Clinical trial NCT00511472
Conditions: Type 2 Diabetes Mellitus
Sponsor: Merck Sharp & Dohme LLC
Start date: 2007-07-01; Completion date: 2008-04-01
Enrollment: 70 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A study to assess safety, pharmacokinetics (PK), and pharmacodynamics (PD) of MK-0941 in Type 2 diabetics being treated with basal insulin.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: MK-0941 intervention 2: Placebo intervention 3: LANTUS insulin
Intervention descriptions: intervention 1: In Titration Scheme #1, MK-0941/matching placebo was initiated at 10-mg q.a.c. dose and increased on a daily basis (Titration Dose \[TD\] Days 1 to 4 of the Titration Phase 1) in 10-mg q.a.c. increments.

Titration Scheme #2 was a flexible-dose titration scheme in which MK-0941/matching placebo was given at a dose determined by a pre-prandial plasma glucose concentration for the subsequent meal on the previous day of administration on Days 1 to 4 of the Titration Phase 2. intervention 2: 10 mg Placebo (Pbo), 20 mg Pbo, 30 mg Pbo or 40 mg Pbo q.a.c. intervention 3: LANTUS insulin dose will be similar to participant's previous dose of immediate or long-acting insulin

Protocol documents:
Clinical trial NCT00511667
Conditions: Type 2 Diabetes Mellitus
Sponsor: Merck Sharp & Dohme LLC
Start date: 2007-05-01; Completion date: 2008-04-01
Enrollment: 70 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A multiple dose study to assess the safety and pharmacokinetics of an investigational drug in patients with type 2 diabetes. The primary hypotheses of the study are that multiple daily MK-0941 in subjects with T2DM with or without adequate control on metformin will be sufficiently safe and well tolerated to permit continued clinical investigation.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: MK0941 intervention 2: Comparator: Placebo
Intervention descriptions: intervention 1: MK0941 10 mg, 20 mg, 30 mg, or 40 mg before each meal or before 2 meals each day, or 60 mg before 2 meals each day intervention 2: Placebo 10 mg, 20 mg, 30 mg, or 40 mg before each meal or before 2 meals each day, or 60 mg before 2 meals each day

Protocol documents:
Clinical trial NCT00513682
Conditions: Cystic Fibrosis Pancreatic Insufficiency
Keywords: Cystic Fibrosis Pancreatic insufficiency Steatorrhea Children 7 to 11 years Pancreatic enzyme
Sponsor: Forest Laboratories
Start date: 2007-07-01; Completion date: 2008-04-01
Enrollment: 9 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a Phase III, multicenter, open-label study, that will evaluate the improvement of nutrient absorption when participants will receive Ultrase® MT20. This study is sponsored by Aptalis (formerly Axcan). This study is performed in children from 7 to 11 years old.

Detailed description:
This is a Phase III, multicenter, open-label study, which will quantify the improvement of nutrient absorption when participants are receiving Ultrase® MT20. The improvement will be demonstrated by comparing the CFA percent (%) and CNA% obtained during a washout of enzyme with the CFA% and CNA% obtained during a period of treatment with Ultrase® MT20. The study is also designed to obtain safety data in CF children suffering also from PI taking Ultrase® MT20. The total duration for the participation of children in this study will be approximately up to 38 days and will include 3 phases: screening phase, the washout phase and treatment phase.

Screening phase: this phase will last 15 days and all participants will take Ultrase® MT20 as per investigator's discretion during this period. During the last 4 days, participants will be stabilized on a high fat diet and with Ultrase® MT20. The individual 'stabilized dose' of Ultrase® MT20 capsules will be determined for each participant based on the average number of capsules of Ultrase® MT20 taken during last 4 days.

Washout phase: this phase will last 6 to 7 days. The participants will continue the high-fat diet but will refrain from taking Ultrase® MT20 or any other enzymes. A 72-hour stool collection will be performed and all food consumed by the participants will be recorded to assess the CFA% and CNA%.

Treatment phase: this phase will last 7 to 11 days. The participants will continue the high-fat diet and will take the 'stabilized dose' of Ultrase® MT20 established during screening. Another 72-hour stool collection will be performed and all food consumed by the participants will be recorded to assess the CFA% and CNA%.

Arms: arm 1: None
Interventions: intervention 1: Ultrase® MT20
Intervention descriptions: intervention 1: Ultrase® MT20 capsules will be administered orally with each meal during Day 1 to 15 in screening phase at a dose based on investigator's discretion. During Day 12 to 15, participants will receive high-fat diet and Ultrase® MT20 dose will be adjusted depending on symptoms of steatorrhea. This will be followed by a washout phase of 6 to 7 days, in which participants will receive only high-fat diet; then stabilized dose of Ultrase® MT20 capsule (as identified during screening phase) will be administered orally for 7 to 11 days during treatment phase. The stabilized dose should not to exceed 2500 lipase units per kilogram body weight per meal (lipase units/kg/meal).

Protocol documents:
Clinical trial NCT00521924
Conditions: Rheumatoid Arthritis
Sponsor: Merck Sharp & Dohme LLC
Start date: 2007-06-01; Completion date: 2008-04-01
Enrollment: 8 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This Phase 3, randomized, open-label, multicenter study in rheumatoid arthritis (RA) patients with low disease activity (Disease Activity Score 28 \[DAS28\] \>2.8 and \<3.5) is being conducted to evaluate induction of remission by adding infliximab to pre-existing treatment versus no additional treatment. All subjects eligible for this study, aged \>35 to \<=65 years, will have a diagnosis of RA according to American College of Rheumatology (ACR) criteria, and will be offered additional treatment with infliximab. Prior to the start of treatment, subjects must be on a stable regimen of disease modifying antirheumatic drugs (DMARDs) for at least 3 months. Subjects will be randomized (1:1) to basic therapy with or without infliximab for a total duration of 38 weeks followed by a follow-up period of up to 6 months. Subjects randomized to basic therapy + infliximab will receive infliximab 3 mg/kg at Weeks 0, 2, 6, 14, 22, 30, and 38. The primary objective of the study is to assess the rate of remission according to DAS 28 (\<2.6) at the end of treatment (after 38 weeks). Safety assessments include the incidence of adverse events, serious adverse events, and clinically notable abnormal vital signs and laboratory values.

Detailed description:

Arms: arm 1: 3 mg/kg infliximab plus basic treatment arm 2: Rheumatoid Arthritis basic therapy (disease modifying anti-rheumatic drugs \[DMARDs\])
Interventions: intervention 1: infliximab intervention 2: DMARDs (methotrexate; chloroquine; leflunomidum; cyclosporin A; sulfasalazine; OM 89.
Intervention descriptions: intervention 1: infliximab 3 mg/kg and basic treatment intervention 2: Methotrexate (15 - 25 mg/week); chloroquine; leflunomidum; cyclosporin A; sulfasalazine; OM 89

Protocol documents:
Clinical trial NCT00527514
Conditions: Hypertension
Keywords: Hypertension Angiotensin Receptor Blocker Calcium Channel Blocker Stage I and II Hypertension
Sponsor: Daiichi Sankyo
Start date: 2007-09-01; Completion date: 2008-04-01
Enrollment: 185 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study will be conducted to assess the efficacy and safety of an amlodipine/olmesartan treatment regimen in stage 1 and stage 2 hypertensive subjects.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Amlodipine intervention 2: Olmesartan medoxomil plus amlodipine
Intervention descriptions: intervention 1: Tablets intervention 2: Tablets

Protocol documents:
Clinical trial NCT00530335
Conditions: Attention Deficit Hyperactivity Disorder
Sponsor: Eli Lilly and Company
Start date: 2007-09-01; Completion date: 2008-04-01
Enrollment: 45 participants; Allocation: ; Intervention model: FACTORIAL

Brief summary:
The objective is to assess overall safety and tolerability of atomoxetine in doses up to 120 mg/day in Japanese adult patients who meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for ADHD

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Atomoxetine
Intervention descriptions: intervention 1: 40 mg/day every day (QD), by mouth (PO), for 1 week; 80 mg/day every day, by mouth, for 1 week; 105 mg/day every day, by mouth, for 2 weeks; 120 mg/day every day, by mouth, for 4 weeks

Protocol documents:
Clinical trial NCT00530946
Conditions: Hypertension Hypercholesterolemia
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2007-09-01; Completion date: 2008-04-01
Enrollment: 165 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To assess the changes in the trough Systolic Blood Pressure (SBP) and the percent changes in Low Density Lipoprotein-Cholesterol (LDL-C) from baseline at Week 8 in the treatment period

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: Amlodipine 2.5mg/Atorvastatin 5mg intervention 2: Amlodipine 2.5mg/Atorvastatin 10mg intervention 3: Amlodipine 5mg/Atorvastatin 5mg intervention 4: Amlodipine 5mg/Atorvastatin 10mg
Intervention descriptions: intervention 1: Single pill combination, dosed once daily for 8 weeks intervention 2: Single pill combination, dosed once daily for 8 weeks intervention 3: Single pill combination, dosed once daily for 8 weeks intervention 4: Single pill combination, dosed once daily for 8 weeks

Protocol documents:
Clinical trial NCT00536731
Conditions: Bronchial Asthma
Keywords: Asthma Symbicort
Sponsor: AstraZeneca
Start date: 2007-09-01; Completion date: 2008-04-01
Enrollment: 742 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the this study is to evaluate the efficacy and safety of 2 actuations Symbicort®pMDI® 40/2.25 μg twice daily compared with1 inhalation Symbicort Turbuhaler® 80/4.5 μg twice daily and 1 inhalation Pulmicort®Turbuhaler® 100 μg twice daily for 6 weeks.

Detailed description:

Arms: arm 1: Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily arm 2: Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily arm 3: Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily
Interventions: intervention 1: Symbicort Turbuhaler intervention 2: Symbicort pMDI intervention 3: Pulmicort Turbuhaler
Intervention descriptions: intervention 1: Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily intervention 2: Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily intervention 3: Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily

Protocol documents:
Clinical trial NCT00545272
Conditions: Asthma
Keywords: QMF indacaterol Twisthaler®
Sponsor: Novartis Pharmaceuticals
Start date: 2007-10-01; Completion date: 2008-04-01
Enrollment: 392 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the dose response relationship among four doses of indacaterol as well as placebo delivered via the TWISTHALER® device.

Detailed description:

Arms: arm 1: Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days. All participants were supplied with salbutamol/albuterol to use throughout the study as rescue medication. arm 2: Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days. All participants were supplied with salbutamol/albuterol to use throughout the study as rescue medication. arm 3: Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days. All participants were supplied with salbutamol/albuterol to use throughout the study as rescue medication. arm 4: Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days. All participants were supplied with salbutamol/albuterol to use throughout the study as rescue medication. arm 5: Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days. All participants were supplied with salbutamol/albuterol to use throughout the study as rescue medication. arm 6: Placebo to indacaterol (placebo TWISTHALER® device) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days. All participants were supplied with salbutamol/albuterol to use throughout the study as rescue medication.
Interventions: intervention 1: indacaterol intervention 2: formoterol intervention 3: placebo to indacaterol intervention 4: placebo to formoterol intervention 5: short acting β2-agonist
Intervention descriptions: intervention 1: Indacaterol delivered by multiple dose dry powder inhaler (TWISTHALER® device). intervention 2: Formoterol delivered by oral inhalation via AEROLIZER® inhalation device. intervention 3: Placebo TWISTHALER® device intervention 4: Placebo AEROLIZER® device intervention 5: 100 μg/ 90 μg salbutamol/albuterol Metered Dose Inhaler (MDI) or equivalent dose of Dry Powder Inhaler (DPI).

Protocol documents: