A Double-blind, Comparative Study in Patients With Gastric Ulcer to Evaluate the Efficacy of Combination Use of E0671 and Rabeprazole Sodium

Phase 4

Completed

• Conditions: Stomach Ulcer
• Interventions: Drug: E0671; Drug: rabeprazole sodium; Drug: E0671 placebo

• Registration Number: NCT00125736
• Lead Sponsor: Eisai Co., Ltd.

Brief Summary

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.

Detailed Description

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).

Study Timeline

• Study First Submitted: 2005-07-29
• Study First Submitted QC: 2005-07-29
• Study Start: 2005-08-01
• Study First Posted: 2005-08-02
• Primary Completion: 2007-04-19
• Study Completion: 2007-04-19
• Status Verified: 2010-01
• Last Update Submitted: 2018-10-26
• Last Update Posted: 2018-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 520

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
E0671 combination group	rabeprazole sodium	-
placebo combination group	rabeprazole sodium	-
placebo combination group	E0671 placebo	-
E0671 combination group	E0671	-

Primary Outcome Measures

Name	Time	Method
Ratio of S2-stage transition at 8 weeks after the study administration.	8 weeks