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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: | NCT00321737 |
A 6-month study to assess the ability of daily treatment with Dexlansoprazole 30mg, 60 mg or placebo in maintaining healing of erosive esophagitis.
Condition | Intervention | Phase |
---|---|---|
Esophagitis, Reflux Esophagitis, Peptic |
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 Safety and Efficacy of TAK-390MR (30 mg QD and 60 mg QD) Compared to Placebo in Maintenance of Healing in Subjects With Healed Erosive Esophagitis. |
Enrollment: | 445 |
Study Start Date: | May 2006 |
Study Completion Date: | May 2007 |
Primary Completion Date: | May 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: Dexlansoprazole
Dexlansoprazole 30 mg, capsules, orally, once daily for up to six months.
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2: Experimental |
Drug: Dexlansoprazole
Dexlansoprazole 60 mg, orally, once daily for up to six months.
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3: Placebo Comparator |
Drug: Placebo
Dexlansoprazole placebo-matching capsules, orally, once daily for up to six months.
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This is a Phase 3, randomized, double-blind, multi-center, placebo-controlled, 6 month maintenance study. The study is designed to compare the efficacy and safety of daily Dexlansoprazole (30 mg and 60 mg) with that of placebo, in maintaining healing of erosive esophagitis.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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-EE05-135, EUDRA CT # 2006-000419-90 |
Study First Received: | May 2, 2006 |
Last Updated: | December 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00321737 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Erosive Esophagitis |
Esophagitis Esophagitis, Peptic Digestive System Diseases Esophageal Disorder Gastrointestinal Diseases Ulcer |
Benzocaine Lansoprazole Esophageal Diseases Gastroenteritis Peptic Ulcer |
Anti-Infective Agents Molecular Mechanisms of Pharmacological Action Gastrointestinal Diseases Gastrointestinal Agents Enzyme Inhibitors Pharmacologic Actions Esophagitis Esophagitis, Peptic |
Digestive System Diseases Therapeutic Uses Anti-Ulcer Agents Esophageal Diseases Lansoprazole Gastroenteritis Peptic Ulcer |