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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: | NCT00627016 |
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) |
Estimated Enrollment: | 300 |
Study Start Date: | March 2008 |
Estimated Study Completion Date: | February 2009 |
Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: Dexlansoprazole
30 mg capsule, orally, once daily for 4 weeks
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2: Placebo Comparator |
Drug: placebo
1 capsule, orally, once daily for 4 weeks
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This 4 week study will be conducted by approximately 50 investigators in the United States in patients suffering from night heartburn.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Takeda Study Registration Call Center | 800-778-2860 | medicalinformation@tpna.com |
Study Chair: | Medical Director | Takeda Global Research & Development Center, Inc. |
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: | December 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00627016 |
Health Authority: | United States: Food and Drug Administration |
Non-Erosive Gastroesophageal Reflux Disease GERD heartburn sleep disturbance nocturnal Reflux |
Pyrosis Signs and Symptoms, Digestive Esophageal disorder Gastrointestinal Diseases Sleep Disorders Dyssomnias Gastroesophageal Reflux |
Esophageal Motility Disorders Deglutition Disorders Signs and Symptoms Digestive System Diseases Heartburn Esophageal Diseases |