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Sponsored by: |
Eisai Limited |
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Information provided by: | Eisai Medical Research Inc. |
ClinicalTrials.gov Identifier: | NCT00770913 |
The purpose of this study is to evaluate the efficacy and safety of E3810 (Aciphex) tablets in patients with Proton Pump Inhibitor-resistant reflux esophagitis.
Condition | Intervention | Phase |
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Refractory Reflux Esophagitis |
Drug: E3810 |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Double-Blind Comparative Study of E3810 Tablets (10 or 20 mg b.i.d.) to Evaluate Efficacy and Safety in Patients With Refractory Reflux Esophagitis |
Estimated Enrollment: | 300 |
Study Start Date: | October 2008 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator |
Drug: E3810
20 mg, taken orally, once a day for 8 weeks.
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2: Experimental |
Drug: E3810
10 mg, taken orally, twice a day for 8 weeks.
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3: Experimental |
Drug: E3810
20 mg taken orally, twice a day for 8 weeks.
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This is a multicenter, randomized, double-blinded study. The efficacy with E3810 (Aciphex) 20 mg once daily will be compared with E3810 20 mg twice daily and 10 mg twice daily using endoscopic recovery. The frequency of adverse events, etc., will be compared among 3 groups for safety assessment.
Ages Eligible for Study: | 20 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Customer Information Services Department. CRC and QA | _ML_CLNCL@hhc.eisai.co.jp |
Study Director: | Tomoki Kubota | Development Clinical Research Dept., Clinical Research Center |
Responsible Party: | Eisai Company Limited ( Customer Information Services Department. CRC and QA ) |
Study ID Numbers: | E3810-J081-304 |
Study First Received: | October 9, 2008 |
Last Updated: | December 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00770913 History of Changes |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
reflux esophagitis rabeprazole GERD Japan |
Esophagitis Esophagitis, Peptic Digestive System Diseases Esophageal Disorder Gastrointestinal Diseases |
Ulcer Esophageal Diseases Gastroenteritis Rabeprazole Peptic Ulcer |
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 Gastroenteritis Peptic Ulcer Rabeprazole |