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Sponsored by: |
Takeda Global Research & Development Center, Inc. |
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Information provided by: | Takeda Global Research & Development Center, Inc. |
ClinicalTrials.gov Identifier: | NCT00251745 |
To assess the efficacy and safety of daily treatment with Dexlansoprazole MR(60 mg or 90 mg) compared to placebo in relief of daytime and nighttime heartburn over 4 weeks in subjects with GERD.
Condition | Intervention | Phase |
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Gastroesophageal Reflux Disease |
Drug: Dexlansoprazole Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase 3 Study to Evaluate the Efficacy and Safety of Dexlansoprazole MR(60 mg QD and 90 mg QD) Compared to Placebo on Symptom Relief in Subjects With Symptomatic Non-Erosive Gastroesophageal Reflux Disease (GERD) |
Enrollment: | 416 |
Study Start Date: | December 2005 |
Study Completion Date: | May 2006 |
Primary Completion Date: | May 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: Dexlansoprazole
Dexlansoprazole 60 mg, capsules, orally, once daily for up to 28 days.
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2: Experimental |
Drug: Dexlansoprazole
Dexlansoprazole 90 mg, capsules, orally, once daily for up to 28 days.
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3: Placebo Comparator |
Drug: Placebo
Dexlansoprazole placebo-matching capsules, orally, once daily for up to 28 days.
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This is a Phase 3, randomized, double-blind, multicenter, placebo-controlled, 3-arm study with a 4 week treatment period. This study will compare the efficacy of daily Dexlansoprazole MR(60 mg and 90 mg) with that of placebo when administered orally as a single daily dose in the morning, before breakfast. The study is designed to evaluate symptom relief in subjects with symptomatic non-erosive GERD. Approximately 450 subjects will be enrolled at approximately 120 U.S. and potentially ex U.S. sites. The study consists of two periods; a screening period, which will last a minimum of 7 days and a maximum of 21 days, and a treatment period, which will last 4 weeks.
Because the development plan for Dexlansoprazole modified release formulation was revised, the results of two identical studies, T-GD04-082 and T-GD04-083, were combined and analyzed as a single larger study referred to as study T-GD04-082
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Medical Director | Takeda Global Research & Development Center, Inc. |
Responsible Party: | Takeda Global Research & Development Center, Inc. ( Sr. VP Clinical Sciences ) |
Study ID Numbers: | T-GD04-082 |
Study First Received: | November 8, 2005 |
Last Updated: | December 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00251745 |
Health Authority: | United States: Food and Drug Administration |
Non-Erosive Gastroesophageal Reflux Disease (GERD) Heartburn |
Deglutition Disorders Esophageal Motility Disorders Pyrosis Digestive System Diseases Esophageal disorder |
Gastrointestinal Diseases Heartburn Esophageal Diseases Gastroesophageal Reflux |