ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00286494
Conditions: Diabetes Mellitus
Keywords: Glucose Metabolism Disorder Dysmetabolic Syndrome Type II Diabetes Diabetes Mellitus Lipoatrophic Dyslipidemia Drug Therapy
Sponsor: Takeda
Start date: 2006-02-01; Completion date: 2007-08-01
Enrollment: 493 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of alogliptin, once daily (QD), combined with pioglitazone in adults with type 2 diabetes mellitus

Detailed description:
There are approximately 19 million people in the United States who have been diagnosed with diabetes mellitus, of which 90% to 95% are type 2. The prevalence of type 2 diabetes varies among racial and ethnic populations and has been shown to correlate with age, obesity, family history, history of gestational diabetes, and physical inactivity. Over the next decade, a marked increase in the number of adults with diabetes mellitus is expected.

Takeda is developing SYR-322 (alogliptin) for the improvement of glycemic control in patients with type 2 diabetes mellitus. Alogliptin is an inhibitor of the dipeptidyl peptidase IV enzyme. Dipeptidyl peptidase IV is thought to be primarily responsible for the degradation of 2 peptide hormones released in response to nutrient ingestion. It is expected that inhibition of dipeptidyl peptidase IV will improve glycemic (glucose) control in patients with type 2 diabetes.

The aim of the current study is to evaluate the efficacy of alogliptin in combination with pioglitazone in subjects who are inadequately controlled on a thiazolidinedione (pioglitazone or rosiglitazone) alone or in combination with metformin or a sulfonylurea. Individuals who participate in this study will be required to commit to a screening visit and up to 14 additional visits at the study center. Study participation is anticipated to be about 34 weeks (or 8.5 months).

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Alogliptin and pioglitazone intervention 2: Alogliptin and pioglitazone intervention 3: Pioglitazone
Intervention descriptions: intervention 1: Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks intervention 2: Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks intervention 3: Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks

Protocol documents:
Clinical trial NCT00309608
Conditions: Diabetes Mellitus, Type 2
Sponsor: Boehringer Ingelheim
Start date: 2006-04-01; Completion date: 2007-08-01
Enrollment: 333 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of the study is to test the efficacy, safety and tolerability of several doses of BI 1356 BS (1, 5, or 10 mg taken once daily) compared to placebo given for 12 weeks together with metformin in patients with type 2 diabetes mellitus who are not at goal with their HbA1c levels. In addition, there will be an unblinded treatment arm with glimepiride as add-on therapy to metformin for comparison. The influence of several factors (gender, age, weight, race, etc.) on the bioavailability and efficacy of BI 1356 BS will also be tested in this study.

Detailed description:

Arms: arm 1: Patients receive Linagliptin low dose tablets once daily arm 2: Patients receive Linagliptin medium dose tablets once daily arm 3: Patients receive Linagliptin high dose tablets once daily arm 4: Patients receive tablets identical to those containing Linagliptin low, medium and high dose arm 5: Patients receive Glimepiride tablets once daily
Interventions: intervention 1: Linagliptin intervention 2: Linagliptin intervention 3: Linagliptin intervention 4: Placebo intervention 5: Glimepiride
Intervention descriptions: intervention 1: Linagliptin medium dose tablet once daily intervention 2: Linagliptin high dose tablet once daily intervention 3: Linagliptin low dose tablet once daily intervention 4: Placebo tablets once daily intervention 5: Glimepiride tablets once daily

Protocol documents:
Clinical trial NCT00317239
Conditions: Anemia
Keywords: Anemia Chronic Kidney Disease Iron
Sponsor: American Regent, Inc.
Start date: 2005-05-01; Completion date: 2007-08-01
Enrollment: 255 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study compares the efficacy and safety of intravenous (IV) iron (VIT45) versus oral iron (ferrous sulfate) administered to subjects who suffer from anemia and are diagnosed with non-dialysis dependent chronic kidney disease (NDD-CKD).

Detailed description:
This study compares the efficacy and safety of intravenous (IV) iron (VIT45) versus oral iron (ferrous sulfate) administered to subjects who suffer from anemia and are diagnosed with non-dialysis dependent chronic kidney disease (NDD-CKD).

Arms: arm 1: A maximum dose of 1,000 mg of FCM over 15 minutes on day 0, and a maximum dose of 500 mg of FCM over 15 minutes on days 17 and 31 based on Ferritin and TSAT values. arm 2: 325 mg/TID x 8 weeks
Interventions: intervention 1: Ferrous Sulfate tablets intervention 2: Ferric Carboxymaltose (FCM)
Intervention descriptions: intervention 1: 325 mg/TID x 8 weeks intervention 2: A maximum dose of 1,000 mg of FCM over 15 minutes on day 0, and a maximum dose of 500 mg of FCM over 15 minutes on days 17 and 31 based on Ferritin and TSAT values.

Protocol documents:
Clinical trial NCT00317356
Conditions: Colitis, Ulcerative
Keywords: OPC-6535 ulcerative colitis
Sponsor: Otsuka Pharmaceutical Co., Ltd.
Start date: 2006-05-01; Completion date: 2007-08-01
Enrollment: 43 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to examine the safety and efficacy of OPC-6535 (tetomilast) and to determine its optimal dose by once-daily oral administration at 0, 12.5, 25, or 50 mg for 8 weeks in combination with a fixed oral dose of 5-aminosalicylic acid (5-ASA) in patients with active ulcerative colitis.

Detailed description:

Interventions: intervention 1: OPC-6535(Tetomilast)
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00317369
Conditions: Crohn Disease
Keywords: OPC-6535 Crohn's disease
Sponsor: Otsuka Pharmaceutical Co., Ltd.
Start date: 2006-05-01; Completion date: 2007-08-01
Enrollment: 29 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study to examine the safety and efficacy of OPC-6535 and determine its optimal dose by once-daily oral administration at 0, 25, or 50 mg for 8 weeks in combination with a fixed oral dose of 5-aminosalicylic acid (5-ASA) or in combination with a fixed oral dose of 5-ASA and enteral nutrition in patients with active Crohn's disease.

Detailed description:

Interventions: intervention 1: OPC-6535(Tetomilast)
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00328172
Conditions: Diabetes Mellitus, Type 2
Sponsor: Boehringer Ingelheim
Start date: 2006-05-01; Completion date: 2007-08-01
Enrollment: 302 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of the current study is to investigate the efficacy, safety and tolerability of several doses of BI 1356 BS (0.5, 2.5 and 5 mg daily) compared to placebo over 12 weeks of treatment in patients with Type 2 diabetes and insufficient glycemic control. In addition, there will be an open-label treatment arm with metformin for sensitivity measurement with this patient population. Population pharmacokinetics of BI 1356 BS will also be assessed in this study.

Detailed description:

Arms: arm 1: Placebo tablets matching BI 1356 arm 2: BI 1356 dose 1 once daily arm 3: BI 1356 dose 2 once daily arm 4: BI 1356 dose 3 once daily arm 5: Metformin
Interventions: intervention 1: Placebo intervention 2: BI 1356 dose 3 once daily intervention 3: BI 1356 dose 2 once daily intervention 4: BI 1356 dose 1 once daily intervention 5: Metformin
Intervention descriptions: intervention 1: Placebo matching BI 1356 intervention 2: BI 1356 dose 3 once daily intervention 3: BI 1356 dose 2 once daily intervention 4: BI 1356 dose 1 once daily intervention 5: Metformin

Protocol documents:
Clinical trial NCT00337610
Conditions: Type 2 Diabetes Mellitus (T2DM)
Sponsor: Merck Sharp & Dohme LLC
Start date: 2006-06-01; Completion date: 2007-08-01
Enrollment: 190 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A clinical study to determine the safety and efficacy of sitagliptin in patients with Type 2 Diabetes Mellitus who have inadequate glycemic (blood sugar) control on metformin therapy.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: sitagliptin 100 mg q.d./metformin ≥ 1500 mg/day intervention 2: comparator: placebo to match sitagliptin 100 mg q.d./metformin ≥ 1500 mg/day
Intervention descriptions: intervention 1: Patients will receive blinded sitagliptin 100 mg q.d. and open-label metformin ≥ 1500 mg/day for up to 30 weeks. Sitagliptin 100 mg q.d. and metformin ≥ 1500 mg/day will be administered as oral tablets. intervention 2: Patients will receive placebo to match sitagliptin 100 mg q.d. and open-label metformin ≥ 1500 mg/day for up to 30 weeks. Sitagliptin 100 mg q.d. and metformin ≥ 1500 mg/day will be administered as oral tablets.

Protocol documents:
Clinical trial NCT00344175
Conditions: Hypercholesterolemia Dyslipidemia Coronary Heart Disease
Keywords: hypercholesterolemia dyslipidemia CHD pitavastatin simvastatin 2 or more risk factors for coronary heart disease combined dyslipidemia
Sponsor: Kowa Research Europe
Start date: 2006-06-01; Completion date: 2007-08-01
Enrollment: 178 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a sixteen-week follow-on and 28 week single-blind extension study for patients who participated in study NK-104-304.

Detailed description:
This is a sixteen-week, double-blind, active controlled, follow-on and 28 week single blind extension study for patients who participated in NK-104-304.

Arms: arm 1: Pitavastatin 4 mg once daily arm 2: Simvastatin 40 mg or 80 mg once daily
Interventions: intervention 1: pitavastatin intervention 2: simvastatin
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00403234
Conditions: Postoperative Pain
Keywords: Postoperative pain opioid transdermal TKA (total knee arthroplasty)
Sponsor: Purdue Pharma LP
Start date: 2006-11-01; Completion date: 2007-08-01
Enrollment: 10 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objectives in this study are to evaluate: (1) efficacy of buprenorphine transdermal system (BTDS, Butrans™) on postoperative pain following total knee replacement surgery; (2) the impact of BTDS on functional rehabilitative measures after total knee replacement surgery; and 3) the safety of BTDS after total knee replacement surgery. The double-blind treatment period is for 28 days during which time supplemental analgesic medication will be provided to all subjects in addition to study drug.

Purdue Pharma L.P. terminated the trial early due to administrative reasons not related to efficacy or safety. The focus of this study became safety evaluations.

Detailed description:
Buprenorphine is a synthetic opioid analgesic with over 25 years of international clinical experience indicating it to be safe and effective in a variety of therapeutic situations for the relief of moderate to severe pain.

Arms: arm 1: Buprenorphine transdermal patch 10 mcg/h applied for 7-day wear arm 2: Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear arm 3: Buprenorphine transdermal patch 30 mcg/h applied for 7-day wear arm 4: Placebo patches were similar to BTDS 10 and 20.
Interventions: intervention 1: Buprenorphine transdermal patch intervention 2: Buprenorphine transdermal patch intervention 3: Buprenorphine transdermal patch intervention 4: Placebo BTDS
Intervention descriptions: intervention 1: Buprenorphine transdermal patch 10 mcg/h applied for 7-day wear. intervention 2: Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear. intervention 3: Buprenorphine transdermal patches 10 mcg/h and 20 mcg/h (total of 30 mcg/h) applied for 7-day wear. intervention 4: Placebo to match BTDS transdermal 10 and 20 patches applied for 7-day wear.

Protocol documents:
Clinical trial NCT00442338
Conditions: Asthma
Sponsor: Organon and Co
Start date: 2007-03-01; Completion date: 2007-08-01
Enrollment: 91 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study estimates the efficacy and safety of MK0476 and aminophylline intravenous administration in adult participants with acute asthma.

Detailed description:

Arms: arm 1: Montelukast 7 mg IV administration arm 2: Montelukast 14 mg IV administration arm 3: Aminophylline 250 mg IV drip administration
Interventions: intervention 1: montelukast sodium intervention 2: montelukast sodium intervention 3: aminophylline hydrate
Intervention descriptions: intervention 1: Montelukast 7 mg single injection (IV bolus administration) over 2-3 minutes intervention 2: Montelukast 14 mg single injection (IV bolus administration) over 5 minutes intervention 3: Aminophylline 250 mg IV drip infusion over 60 minutes

Protocol documents:
Clinical trial NCT00654784
Conditions: Duchenne Muscular Dystrophy (DMD)
Keywords: Duchenne Muscular Dystrophy DMD Duchenne
Sponsor: Santhera Pharmaceuticals
Start date: 2005-10-01; Completion date: 2007-08-01
Enrollment: 21 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Idebenone is a synthetic analogue of coenzyme Q10 and is a powerful antioxidant and essential constituent of the process of energy production on the cellular level. It can protect mitochondria from oxidative damage and boost their impaired function. It is thought that this mechanism will slow decline in heart function that is part of the disease process of Duchenne Muscular Dystrophy (DMD). It is possible that patients may benefit in terms of muscle strength and respiratory function. This pilot trial is designed to investigate this.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: idebenone intervention 2: placebo
Intervention descriptions: intervention 1: idebenone 450 mg/day (150 mg three times a day) intervention 2: None

Protocol documents:
Clinical trial NCT00751790
Conditions: Prostatic Neoplasm
Keywords: triptorelin, 6-month formulation, advanced prostate cancer
Sponsor: Debiopharm International SA
Start date: 2006-07-01; Completion date: 2007-08-01
Enrollment: 120 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Efficacy and safety of a triptorelin 6-month formulation in patients with advanced prostate cancer. It was assumed that during the study treatment \>90% of the patients would achieve and maintain castrate levels of serum testosterone.

Detailed description:
Efficacy of triptorelin treatment on gonadotropin (LH) stimulation from hypophysis, as well as on the PSA (prostate specific antigen) levels and safety laboratory parameters. The triptorelin pharmacokinetics and testosterone pharmacodynamics were assessed in a subset of 15 patients.

Arms: arm 1: None
Interventions: intervention 1: triptorelin embonate (INN)
Intervention descriptions: intervention 1: Triptorelin embonate 22.5 mg 6 month formulation to be injected every 24 weeks

Protocol documents:
Clinical trial NCT00806078
Conditions: Healthy
Keywords: Healthy Bioequivalence Pharmacokinetics
Sponsor: Mutual Pharmaceutical Company, Inc.
Start date: 2007-07-01; Completion date: 2007-08-01
Enrollment: 18 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This is an open label randomized single dose two-way crossover study to compare the bioavailability of a single oral dose of quinine sulfate 648 mg(2 x 324 mg) when mixed with 120 ml of chocolate pudding relative to the same dose given as two intact capsules.

Detailed description:
Prior studies have shown that intact quinine sulfate capsules can be taken without regard for food. This is an open label randomized single dose two-way crossover study to compare the bioavailability of a single oral dose of quinine sulfate 648mg(2 x 324 mg capsules) when opened and mixed with 120 ml of chocolate pudding relative to the same dose given as two intact capsules. Eighteen healthy adult subjects will be enrolled. Following a fast of at least 10 hours subjects will be randomized to receive either 648 mg of quinine sulfate as the intact capsules or opened mixed in 120ml of chocolate pudding. Following a washout period of at least 7 days all subjects will be given the alternate dose under similar conditions. Following each dose, blood samples will be collected at times sufficient to determine the difference in bioavailability (if any) between the two methods of drug administration. In addition patients will be monitored for any adverse events including Electrocardiogram (EKG) changes (at baseline and 4 hours after each dose).

Arms: arm 1: Single dose intact capsules 2 x 324 mg arm 2: Single dose contents of two capsules (2 x 324 mg) opened and mixed in 120 mL of chocolate pudding
Interventions: intervention 1: quinine sulfate intervention 2: quinine sulfate
Intervention descriptions: intervention 1: 2 x 324 mg capsules (648 mg) intervention 2: 2 x 324 mg capsules (648 mg)

Protocol documents:
Clinical trial NCT00943124
Conditions: Dyslipidemia
Sponsor: Merck Sharp & Dohme LLC
Start date: 2007-07-01; Completion date: 2007-08-01
Enrollment: 220 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study will evaluate:

1. the bioequivalence of simvastatin and simvastatin acid following dose of simvastatin (ZOCOR™) given together with one tablet of MK0524A or as a component of the triple combination tablet MK0524B.
2. the bioequivalence of laropiprant and ER niacin when administered as the triple combination tablet MK0524B or as the double combination tablet MK0524A given together with simvastatin.

Detailed description:

Arms: arm 1: Period 1: 1 tablet of MK0524B (ER niacin 900 mg/ laropiprant 20 mg/ simvastatin 20 mg).

Period 2: 1 tablet of simvastatin 20 mg (Zocor™) and 1 tablet of MK0524A (ER niacin 1000 mg/ laropiprant 20 mg) as separate tablets. arm 2: Period 1: 1 tablet of simvastatin 20 mg (Zocor™) and 1 tablet of MK0524A (ER niacin 1000 mg/ laropiprant 20 mg) as separate tablets.

Period 2: 1 tablet of MK0524B (ER niacin 900 mg/ laropiprant 20 mg/ simvastatin 20 mg).
Interventions: intervention 1: MK0524B (ER niacin (+) laropiprant (+) simvastatin) intervention 2: MK0524A (ER niacin + laropiprant) intervention 3: Simvastatin
Intervention descriptions: intervention 1: Single dose of MK0524B (ER niacin 900 mg/ laropiprant 20 mg/ simvastatin 20 mg) in one of two treatment periods. intervention 2: Single dose of MK0524A (ER niacin 1000 mg/ laropiprant 20 mg) in one of two treatment periods. intervention 3: Single dose simvastatin (Zocor™) 20 mg in one of two treatment periods.

Protocol documents:
Clinical trial NCT02806505
Conditions: Hepatitis C, Chronic
Sponsor: Hoffmann-La Roche
Start date: 2004-06-01; Completion date: 2007-08-01
Enrollment: 81 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study evaluated the safety and efficacy of peginterferon alfa-2a monotherapy in participants with Chronic Hepatitis C (CHC) who have End-Stage Renal Disease (ESRD) and were undergoing hemodialysis.

Detailed description:

Arms: arm 1: Chronic Hepatitis C participants with end-stage renal disease undergoing hemodialysis will receive Peginterferon alfa-2a 135 mcg subcutaneously (SC) once weekly up to Week 48. arm 2: Chronic Hepatitis C participants with end-stage renal disease undergoing hemodialysis will receive Peginterferon alfa-2a 90 mcg SC once weekly up to Week 48.
Interventions: intervention 1: Peginterferon alfa-2a
Intervention descriptions: intervention 1: Chronic Hepatitis C participants with end-stage renal disease undergoing hemodialysis will receive Peginterferon alfa-2a either 135 or 90 mcg SC once weekly up to Week 48.

Protocol documents:
Clinical trial NCT00400725
Conditions: Scalp Psoriasis
Keywords: maintenance scalp psoriasis Galderma
Sponsor: Galderma R&D
Start date: 2006-09-29; Completion date: 2007-08-20
Enrollment: 288 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of the study was to assess the maintenance effect on scalp psoriasis of Clobex® Shampoo 0.05% when used twice weekly.

Detailed description:
Psoriasis was a chronic disease that was affecting skin, the scalp and joints. Scalp psoriasis was very common and was having an important impact on people's life.

Primary objective of scalp psoriasis treatments was to gain initial and rapid control of the disease process with a minimum of side-effects and improve patient quality of life.

Still, one of the unmet needs of scalp psoriasis therapies was the maintenance of a long-term remission. For corticosteroids in particular, one of the drawbacks was the disease recurrences after cessation of the treatment.

Therefore, the establishment of a modified corticosteroid dosing regimen that would allow remission with minimal side-effects was suitable.

The purpose of this study was to assess how long a patient successfully maintained in a good condition after use of Clobex® shampoo only twice a week.

Arms: arm 1: In initial open-label phase, participants were applied Clobex® shampoo (Clobetasol Propionate) 0.05 percent (%) weight by weight (W/W) topically to the scalp once daily (twice a week) for 4 weeks (weekly dose was not more than 50 grams \[50 Milliliter\]). arm 2: In maintenance double-blind phase, participants presented with a good efficacy (Global severity score \[GSS\] less than or equal to \[\<=\] 2) in initial phase were randomized to apply Clobetasol Propionate shampoo 0.05 % weight by weight (W/W) twice weekly up to 6 months (wherein weekly dose were not exceeded beyond 50 grams \[50 milliliter\]). In case of relapse (that is \[i.e.\], GSS greater than \[\>\] 2) participants were re-entered to 4-week daily treatment with Clobetasol Propionate shampoo 0.05%. After this 4-week period of daily treatment, if GSS \<= 2, participants were re-entering the maintenance regimen (twice a week). arm 3: In maintenance double-blind phase, participants presented with a good efficacy (Global severity score \[GSS\] \<= 2) in initial phase were randomized to apply Clobex® vehicle shampoo twice weekly up to 6 months (wherein weekly dose was not more than 50 grams \[50 milliliter\]). In case of relapse (i.e., GSS \[greater than\] \> 2) participants were re-entered to 4-week daily treatment with Clobetasol Propionate Shampoo 0.05 % (W/W). After this 4-week period of daily treatment, if GSS \<= 2, participants were re-entering the maintenance regimen (twice a week).
Interventions: intervention 1: Clobex® Shampoo intervention 2: Clobex® Vehicle Shampoo intervention 3: Clobex® Shampoo
Intervention descriptions: intervention 1: Clobex® Shampoo 0.05 % (W/W) topically to scalp for 4 weeks. intervention 2: Clobex® Vehicle Shampoo 0.05 % (W/W) topically to scalp up to 6 months. intervention 3: Clobex® Shampoo 0.05% (W/W) topically to scalp up to 6 months.

Protocol documents: