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Sponsored by: |
Eisai Limited |
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Information provided by: | Eisai Medical Research Inc. |
ClinicalTrials.gov Identifier: | NCT00125736 |
The purpose of this study is to investigate the efficacy and safety of combination use of E0671 and Rabeprazole Sodium in patients with gastric ulcer.
Condition | Intervention | Phase |
---|---|---|
Stomach Ulcer |
Drug: Teprenone |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study |
Official Title: | A Double-Blind, Comparative Study in Patients With Gastric Ulcer to Evaluate the Efficacy of Combination Use of E0671 and Rabeprazole Sodium |
Estimated Enrollment: | 520 |
Study Start Date: | August 2005 |
The efficacy and safety of E0671 in combination with Rabeprazole Sodium (i.e., 10 mg/day of rabeprazole sodium and 150 mg/day of E0671) will be investigated in patients with gastric ulcer in a multicenter, randomized, double-blind, parallel-group comparative study using a placebo control group (10 mg/day of rabeprazole sodium and placebo for E0671).
Ages Eligible for Study: | 20 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Patients with gastric ulcer who meet all of the following items. Gender and treatment class (in-patient or out-patient) are not asked.
Patients who meet any of the following conditions:
Exclusion criteria:
Study Director: | Toshihisa Arai | GI Group. Post-Marketing Clinical Research Dept., Clinical Research Center |
Study ID Numbers: | E0671-J081-291 |
Study First Received: | July 29, 2005 |
Last Updated: | September 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00125736 |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Stomach Ulcer Stomach Diseases Digestive System Diseases Gastrointestinal Diseases |
Ulcer Rabeprazole Peptic Ulcer |
Pathologic Processes Molecular Mechanisms of Pharmacological Action Therapeutic Uses Anti-Ulcer Agents |
Gastrointestinal Agents Enzyme Inhibitors Pharmacologic Actions |