ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01129011
Conditions: Gastric Ulcer
Keywords: NSAID gastric ulcers Vimovo Esomeprazole Naproxen
Sponsor: POZEN
Start date: 2007-09-01; Completion date: 2008-10-01
Enrollment: 420 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study uses a randomized, double-blind, controlled design to demonstrate that PN400 (esomeprazole and naproxen) is more effective in reducing the occurrence of gastroduodenal ulcers, dyspepsia, and heartburn in subjects at risk for developing NSAID-associated gastric ulcers compared to naproxen alone.

Detailed description:
Objectives:

Primary: To demonstrate that PN400 is effective in reducing the risk of gastric ulcers in subjects at risk for developing NSAID-associated gastric ulcers.

Secondary:

* To determine if PN400 is effective in reducing the risk of duodenal ulcers in subjects at risk for developing NSAID-associated ulcers
* To compare upper gastrointestinal symptoms in subjects treated with PN400 versus naproxen as measured by scores on the Severity of Dyspepsia Assessment (SODA) instrument and the Overall Treatment Evaluation - Dyspepsia (OTE-DP)
* To compare heartburn symptoms in subjects treated with PN400 versus naproxen
* To evaluate the safety and tolerability of PN400 and naproxen

Arms: arm 1: Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg dosed twice daily arm 2: Naproxen 500 mg dosed twice daily
Interventions: intervention 1: PN400 (VIMOVO) intervention 2: Naproxen
Intervention descriptions: intervention 1: PN400 tablets (Naproxen 500 mg and Esomeprazole 20 mg) twice daily (bid) taken orally. intervention 2: Naproxen 500 mg dosed twice daily (bid) orally

Protocol documents:
Clinical trial NCT01217801
Conditions: Healthy
Sponsor: MonoSol Rx
Start date: 2008-10-01; Completion date: 2008-10-01
Enrollment: 48 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to assess the single dose bioequivalence of Ondansetron ODFS 8mg with Zofran ODT® (Containing Ondansetron 8 mg) in healthy, male and female adult, human study participants under fed conditions.

The purpose is to monitor clinical status, adverse events, laboratory investigations and to assess relative safety and tolerance of ondansetron formulations under fed conditions.

Detailed description:
An open-label randomized, single oral dose, two way crossover bioequivalence study to compare ondansetron Orally Dissolving FilmStrip (ODFS) 8mg with Zofran Orally Disintegrating Tablets \[ODT® (Containing Ondansetron 8 mg)\] in 48 healthy, adult, human study participants under fed conditions. Volunteers who signed the consent form and showed their willingness to participate in the study were enrolled. Volunteers who satisfied the inclusion and exclusion criteria and found to be healthy on physical examination with laboratory investigation values within reference limits were considered eligible to be admitted into the study. Study participants were fasted for 10 hours prior to dosing in both periods. Dosing was conducted as per the randomization schedule in each period under fed conditions.A washout period of 7 days was observed between the two periods.

Arms: arm 1: single dose of Ondansetron Orally Dissolving Filmstrip 8 mg arm 2: Single dose of Zofran (Ondansetron) ODT Orally Disintegrating Tablets 8 mg
Interventions: intervention 1: Ondansetron (ODFS) intervention 2: Ondansetron (ODT)
Intervention descriptions: intervention 1: Ondansetron Orally Dissolving Filmstrip Ondansetron (ODFS) intervention 2: Ondansetron Orally Disintegrating Tablet Ondanestron (ODT)

Protocol documents:
Clinical trial NCT01263509
Conditions: Type 2 Diabetes Mellitus
Keywords: Diabetes Mellitus - Type 2 Diabetes Mellitus Drug Therapy
Sponsor: Takeda
Start date: 2007-06-01; Completion date: 2008-10-01
Enrollment: 179 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to evaluate the long-term safety and efficacy of alogliptin and an α-glucosidase inhibitor administered once daily (QD) or three times daily (TID) for 40 consecutive weeks in participants who completed a phase 2/3 α-glucosidase inhibitor add on study.

Detailed description:
Both insulin hyposecretion and insulin-resistance are considered to be involved in the development of type 2 diabetes mellitus.

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 (DPP-IV) enzyme. DPP-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 DPP-IV will improve glycemic control in patients with type 2 diabetes.

"To evaluate the long-term safety and efficacy of alogliptin and an α-glucosidase inhibitor, this extension study was administered for 40 consecutive weeks (52 weeks from the start of treatment in the phase 2 dose-ranging study) to participants who completed a phase 2/3 α-glucosidase inhibitor add on study 322/CCT-003 (NCT01263483).

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Alogliptin and voglibose intervention 2: Alogliptin and voglibose
Intervention descriptions: intervention 1: Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks. intervention 2: Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.

Protocol documents:
Clinical trial NCT01318070
Conditions: Type 2 Diabetes Mellitus
Keywords: Diabetes Mellitus - Type2 Diabetes Mellitus Drug Therapy
Sponsor: Takeda
Start date: 2007-11-01; Completion date: 2008-10-01
Enrollment: 339 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to evaluate the efficacy and safety of alogliptin, once daily (QD) combined with a thiazolidine taken QD in type 2 diabetic patients with uncontrolled blood glucose.

Detailed description:
Both insulin hyposecretion and insulin-resistance are considered to be involved in the development of type 2 diabetes mellitus.

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 (DPP-IV) enzyme. DPP-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 DPP-IV will improve glycemic control in patients with type 2 diabetes.

The present study was planned to evaluate the efficacy and safety of alogliptin as an add-on to pioglitazone in type 2 diabetic patients with uncontrolled blood glucose despite treatment with pioglitazone as well as diet and exercise therapies.

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 12.5mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks. intervention 2: Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks. intervention 3: Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.

Protocol documents:
Clinical trial NCT01846442
Conditions: Vaginal Atrophy
Keywords: Vulvar/vaginal atrophy Atrophic Vaginitis Dehydroepiandrosterone DHEA Prasterone Vaginorm Menopause Intrarosa
Sponsor: EndoCeutics Inc.
Start date: 2007-06-01; Completion date: 2008-10-01
Enrollment: 218 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the dose-response of vaginal mucosa parameters to the local action of DHEA (Dehydroepiandrosterone) in postmenopausal women suffering from vaginal atrophy.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: Placebo intervention 2: DHEA (0.25%) intervention 3: DHEA (0.5%) intervention 4: DHEA (1.0%)
Intervention descriptions: intervention 1: Placebo vaginal suppository containing 0.0% (0 mg) DHEA; daily dosing with one suppository for 12 weeks. intervention 2: Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks. intervention 3: Vaginal suppository containing 0.5% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks. intervention 4: Vaginal suppository containing 1.0% (13 mg) DHEA; daily dosing with one suppository for 12 weeks.

Protocol documents:
Clinical trial NCT01870999
Conditions: Schizophrenia
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Start date: 2007-11-01; Completion date: 2008-10-01
Enrollment: 41 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the safety, tolerability, efficacy and pharmacokinetics of aripiprazole intramuscular (IM) depot multiple doses every 4 weeks in adult patients with schizophrenia.

Detailed description:

Arms: arm 1: 400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14. arm 2: 300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14. arm 3: 200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
Interventions: intervention 1: aripiprazole IM depot intervention 2: aripiprazole tablets
Intervention descriptions: intervention 1: Aripiprazole IM depot supplied as 200 mg or 400 mg vials of lyophilized aripiprazole powder to prepare for IM injection. intervention 2: Aripiprazole tablets 10 mg once daily in the morning for 14 days.

Protocol documents:
Clinical trial NCT01909778
Conditions: Hepatitis C Liver Cirrhosis
Sponsor: Boehringer Ingelheim
Start date: 2008-06-01; Completion date: 2008-10-01
Enrollment: 2 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This trial was intended to investigate the pharmacokinetics, safety and tolerability of BI 201335 NA soft-gel capsules in patients with compensated liver cirrhosis, i.e. grade A according to Child-Pugh classification (\< 7 points).

Detailed description:

Arms: arm 1: BI 201335 two single oral doses, separated by 14 days washout period
Interventions: intervention 1: BI 201335
Intervention descriptions: intervention 1: single oral doses

Protocol documents:
Clinical trial NCT02799082
Conditions: Actinic Keratosis
Sponsor: Biofrontera Bioscience GmbH
Start date: 2007-12-01; Completion date: 2008-10-01
Enrollment: 122 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of the study was to evaluate the efficacy and safety of BF-200 ALA (Ameluz) used with photodynamic therapy (PDT) in patients suffering from actinic keratosis.

Detailed description:
The treatment comprised of one PDT session. If 12 weeks after PDT all lesions were cleared the patient entered the follow-up period. In case of remaining lesions or not completely cleared lesions the patient received a second PDT on the same day. The final assessment was performed 12 weeks after the last PDT and the patient moved to the follow-up phase.

Arms: arm 1: Topical application of matched placebo gel (without containing active ingredient). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin. arm 2: Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.
Interventions: intervention 1: Vehicle intervention 2: BF-200 ALA
Intervention descriptions: intervention 1: topical treatment for photodynamic therapy combining vehicle application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation). intervention 2: topical treatment for photodynamic therapy combining drug application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation).

Protocol documents:
Clinical trial NCT00603382
Conditions: Asthma
Keywords: Adults Pharmacokinetics Pharmacogenetics Asthma Adolescents GW685698X
Sponsor: GlaxoSmithKline
Start date: 2007-12-01; Completion date: 2008-10-02
Enrollment: 599 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to determine if the investigational drug is effective and safe in individuals with asthma.

Detailed description:
A Randomized Double-Blind, Double-Dummy, Placebo-Controlled, Parallel-Group, Multicenter, Dose Ranging Study to Evaluate the Efficacy and Safety of GW685698X Inhalation Powder Once Daily and Fluticasone Propionate Inhalation Powder Twice Daily compared with Placebo for 8 Weeks in Adolescent and Adult Subjects with Persistent Asthma Symptomatic on Non-Steroidal, Asthma Therapy

Arms: arm 1: None arm 2: None
Interventions: intervention 1: GW685698X intervention 2: Placebo
Intervention descriptions: intervention 1: GW685698X intervention 2: placebo comparator

Protocol documents:
Clinical trial NCT01217190
Conditions: Nausea and Vomiting, Postoperative Nausea With Vomiting Chemotherapy-Induced
Keywords: Bioequivalence, safety, and tolerability
Sponsor: MonoSol Rx
Start date: 2008-09-16; Completion date: 2008-10-06
Enrollment: 48 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This was an open-label, balanced, two-treatment, two-period, randomized sequence crossover bioequivalence study with a 7-day washout between periods. Each treatment was administered after an overnight (10 hours) fast.

Detailed description:
This was an open label, balanced, randomized, two-treatment, two-period, randomized sequence crossover study conducted in healthy adult male and female volunteers. Subjects checked into the study center on Day -1 of each study period at least 12 hours prior to dosing on Day 1. Subjects were served dinner between 8:00 pm to 8:30 pm to ensure minimum 10 hours fast prior to dosing in both periods. Subjects received the 2 treatments in a randomized order with a 7-day washout between the 2 periods.

Treatment A: single dose of ondansetron ODFS 8 mg was orally administered, allowed to dissolve, swallowed with saliva, followed with 240 mL room temperature drinking water

Treatment B: single dose of Zofran ODT (containing ondansetron 8 mg) was orally administered, allowed to dissolve, swallowed with saliva, followed with 240 mL room temperature drinking water

Arms: arm 1: Single dose of Ondansetron Orally Dissolving Film Strip 8 mg followed by single dose of Zofran ODT® Orally Disintegrating Tablet containing Ondansetron 8 mg with 7 days washout between the 2 periods arm 2: Single dose of Zofran ODT® Orally Disintegrating Tablet containing Ondansetron 8 mg followed by single dose of Ondansetron Orally Dissolving Film Strip 8 mg with 7 days washout between the 2 periods
Interventions: intervention 1: Ondansetron (ODFS) intervention 2: Zofran (ODT)
Intervention descriptions: intervention 1: Test Article intervention 2: Comparator

Protocol documents:
Clinical trial NCT00395343
Conditions: Type 2 Diabetes Mellitus
Sponsor: Merck Sharp & Dohme LLC
Start date: 2006-12-11; Completion date: 2008-10-13
Enrollment: 641 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 control on insulin or insulin/metformin combination therapy.

Detailed description:

Arms: arm 1: sitagliptin arm 2: Placebo
Interventions: intervention 1: sitagliptin phosphate intervention 2: Comparator : placebo (unspecified)
Intervention descriptions: intervention 1: sitagliptin 100 mg tablet qd for a 24-wk treatment period. intervention 2: sitagliptin 100 mg Pbo tablet qd for a 24-wk treatment period.

Protocol documents:
Clinical trial NCT00710710
Conditions: Pancreatic Neoplasms
Sponsor: Boehringer Ingelheim
Start date: 2006-08-01; Completion date: 2008-10-14
Enrollment: 89 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The trial is conducted in order to evaluate the efficacy, safety and pharmacokinetics of BI 2536 in the treatment of unresectable advanced pancreatic cancer as first line or second line therapy. A secondary aim is to identify the most suitable dosage regimen for the further phase II and III clinical programme of BI 2536. To achieve this objective, two dosage regimens are compared in patients receiving first line therapy.

Detailed description:

Arms: arm 1: Day 1 arm 2: Day 1 - 3
Interventions: intervention 1: BI 2536
Intervention descriptions: intervention 1: Intravenous Infusion

Protocol documents:
Clinical trial NCT00507026
Conditions: Postoperative Pain
Sponsor: Pfizer
Start date: 2007-07-25; Completion date: 2008-10-14
Enrollment: 277 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will compare repeated intermittent IV dosing of diclofenac in patient with moderate to severe post-surgical pain from elective orthopedic surgery.

Detailed description:
The primary objective is to evaluate the analgesic efficacy and safety of three dosage levels of parenteral diclofenac in providing pain relief as compared to placebo or Ketorolac tromethamine.

Arms: arm 1: DIC075V (IV diclofenac) arm 2: IV Ketorolac arm 3: Placebo
Interventions: intervention 1: IV Diclofenac intervention 2: IV ketorolac intervention 3: Placebo
Intervention descriptions: intervention 1: IV Diclofenac q6h intervention 2: IV ketorolac q6h intervention 3: Placebo q6h

Protocol documents:
Clinical trial NCT00420641
Conditions: Depressive Disorder
Keywords: MDD flexible-dose Major Depressive Disorder paroxetine GSK372475
Sponsor: GlaxoSmithKline
Start date: 2006-12-19; Completion date: 2008-10-15
Enrollment: 492 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the efficacy, safety and tolerability of GSK372475 compared with placebo in the treatment of outpatients subjects with major depressive disorder to exhibit decreased pleasure, interest and energy.

Detailed description:

Arms: arm 1: GSK372475 1.0- 1.5 mg/day arm 2: Paroxetine 20-30 mg/day arm 3: Placebo to Match
Interventions: intervention 1: GSK372475 intervention 2: Paroxetine intervention 3: Placebo
Intervention descriptions: intervention 1: GSK372475 1.0-1.5 mg/day intervention 2: Paroxetine 20-30 mg/day intervention 3: Placebo to Match

Protocol documents:
Clinical trial NCT00958334
Conditions: Uterine Fibroids
Keywords: Uterine fibroids
Sponsor: Repros Therapeutics Inc.
Start date: 2006-09-07; Completion date: 2008-10-15
Enrollment: 65 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
ZPU-003 EXT is a 2-year extension study of ZPU-003 (NCT00882258) to determine the continued safety and efficacy of Proellex in women who have previously completed the double-blind portion of the study.

Detailed description:
ZPU-003 EXT is a 2-year extension study of ZPU-003 (NCT00882258). The purpose of the study is to determine the continued safety and efficacy of Proellex in women who have previously completed the double-blind portion of the study. The desired primary efficacy outcome will be a changes in vaginal bleeding from baseline to 14 months and 17 months on study drug. The total duration of the study is up to 24 months including transition times, off drug intervals, and follow-up visits). It is expected that over a 16 week on drug interval menses will subside and return after a 4-8 week off drug interval (ODI).

Arms: arm 1: Two Proellex® 12.5 mg capsules once daily arm 2: One Proellex® 12.5 mg capsules once daily arm 3: Capsule once a day
Interventions: intervention 1: Proellex®
Intervention descriptions: intervention 1: 25 mg daily (two 12.5 mg capsules)

Protocol documents:
Clinical trial NCT00112463
Conditions: Adult Alveolar Soft-part Sarcoma Adult Angiosarcoma Adult Epithelioid Sarcoma Adult Extraskeletal Chondrosarcoma Adult Extraskeletal Osteosarcoma Adult Fibrosarcoma Adult Leiomyosarcoma Adult Liposarcoma Adult Malignant Fibrous Histiocytoma Adult Malignant Hemangiopericytoma Adult Malignant Mesenchymoma Adult Neurofibrosarcoma Adult Rhabdomyosarcoma Adult Synovial Sarcoma Gastrointestinal Stromal Tumor Metastatic Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor Recurrent Adult Soft Tissue Sarcoma Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor Stage III Adult Soft Tissue Sarcoma Stage IV Adult Soft Tissue Sarcoma
Sponsor: National Cancer Institute (NCI)
Start date: 2005-01-07; Completion date: 2008-10-23
Enrollment: 40 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial studies how well depsipeptide (romidepsin) works in treating patients with metastatic or unresectable soft tissue sarcoma. Drugs used in chemotherapy, such as depsipeptide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

Detailed description:
PRIMARY OBJECTIVES:

I. To estimate the response rates of metastatic or unresectable soft tissue sarcomas to single-agent depsipeptide.

II. To estimate the time to progression of metastatic or unresectable soft tissue sarcomas to single-agent depsipeptide.

III. To evaluate the scope and extent of acute toxicities associated with single-agent depsipeptide when given to patients with soft tissue sarcomas.

OUTLINE: This is a multicenter study.

Patients receive depsipeptide (romidepsin) intravenously (IV) over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 6 additional courses beyond documentation of CR.

After completion of study treatment, patients are followed up every 2 months.

Arms: arm 1: Patients receive depsipeptide (romidepsin) intravenously (IV) over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 6 additional courses beyond documentation of CR.
Interventions: intervention 1: romidepsin
Intervention descriptions: intervention 1: DEP is administered at a dose of 13 mg/m2 as a 4-hour intravenous infusion in the outpatient setting.

Protocol documents: