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| Sponsor: | Takeda Global Research & Development Center, Inc. |
|---|---|
| Information provided by: | Takeda Global Research & Development Center, Inc. |
| ClinicalTrials.gov Identifier: | NCT00627016 |
Purpose
The purpose of this study is to determine whether Dexlansoprazole is effective in treating patients with night heartburn.
| Condition | Intervention | Phase |
|---|---|---|
|
Gastroesophageal Reflux |
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 Multicenter, Randomized, Double-Blind, Parallel Group, Placebo Controlled Trial to Evaluate the Efficacy of TAK-390MR (30 mg QD) Compared to Placebo on Relief of Nocturnal Heartburn in Subjects With Symptomatic Gastroesophageal Reflux Disease (GERD) |
| Enrollment: | 305 |
| Study Start Date: | March 2008 |
| Study Completion Date: | March 2009 |
| Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental |
Drug: Dexlansoprazole
30 mg capsule, orally, once daily for 4 weeks
|
| 2: Placebo Comparator |
Drug: placebo
1 capsule, orally, once daily for 4 weeks
|
This 4 week study will be conducted by approximately 50 investigators in the United States in patients suffering from night heartburn.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 43 Study Locations| Study Chair: | Medical Director | Takeda Global Research & Development Center, Inc. |
More Information
| Responsible Party: | Takeda Global Research & Development Center, Inc. ( Sr. VP Clinical Sciences ) |
| Study ID Numbers: | T-GD07-170 |
| Study First Received: | February 21, 2008 |
| Last Updated: | June 22, 2009 |
| ClinicalTrials.gov Identifier: | NCT00627016 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Non-Erosive Gastroesophageal Reflux Disease GERD heartburn sleep disturbance nocturnal Reflux |
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Anti-Infective Agents Molecular Mechanisms of Pharmacological Action Signs and Symptoms, Digestive Gastrointestinal Diseases Gastrointestinal Agents Enzyme Inhibitors Gastroesophageal Reflux Pharmacologic Actions Esophageal Motility Disorders |
Deglutition Disorders Signs and Symptoms Digestive System Diseases Therapeutic Uses Anti-Ulcer Agents Heartburn Esophageal Diseases Lansoprazole |