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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: | NCT00321984 |
The purpose of this study is to assess the efficacy and safety of Dexlansoprazole modified release (MR) (30 mg once daily [QD] or 60 mg QD) compared to placebo in relief of daytime and nighttime heartburn over 4 weeks in subjects with symptomatic, nonerosive gastroesophageal reflux disease (GERD).
Condition | Intervention | Phase |
---|---|---|
Gastroesophageal Reflux Disease |
Drug: Dexlansoprazole MR 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 (30 mg QD and 60 mg QD) Compared to Placebo on Symptom Relief in Subjects With Symptomatic Nonerosive Gastroesophageal Reflux Disease (GERD) |
Enrollment: | 947 |
Study Start Date: | June 2006 |
Study Completion Date: | December 2006 |
Primary Completion Date: | December 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: Dexlansoprazole MR
Dexlansoprazole MR 30 mg, capsules, orally, once daily for 4 weeks.
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2: Experimental |
Drug: Dexlansoprazole MR
Dexlansoprazole MR 60 mg, capsules, orally, once daily for 4 weeks.
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3: Placebo Comparator |
Drug: Placebo
Dexlansoprazole placebo-matching capsules, orally, once daily for 4 weeks.
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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 Dexlansoprazole MR (30 mg QD and 60 mg QD) 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 nonerosive GERD. Approximately 900 subjects will be enrolled at approximately 200 United States (US) and potentially ex-US 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.
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-GD05-137, EUDRA CT# 2006-000420-13 |
Study First Received: | May 2, 2006 |
Results First Received: | February 26, 2009 |
Last Updated: | April 16, 2009 |
ClinicalTrials.gov Identifier: | NCT00321984 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Gastroesophageal Reflux Disease(GERD) Heartburn |
Deglutition Disorders Esophageal Motility Disorders Pyrosis Digestive System Diseases Esophageal Disorder |
Gastrointestinal Diseases Heartburn Lansoprazole Esophageal Diseases Gastroesophageal Reflux |
Anti-Infective Agents Molecular Mechanisms of Pharmacological Action Gastrointestinal Diseases Gastrointestinal Agents Enzyme Inhibitors Gastroesophageal Reflux Pharmacologic Actions |
Esophageal Motility Disorders Deglutition Disorders Digestive System Diseases Therapeutic Uses Anti-Ulcer Agents Esophageal Diseases Lansoprazole |