NCT01089543
Completed
Phase 2
A Multi-Center, Randomized, Double-Blind Study of E3810 for Japanese Subjects With Functional Dyspepsia
Overview
- Phase
- Phase 2
- Intervention
- Rabeprazole
- Conditions
- Functional Dyspepsia
- Sponsor
- Eisai Co., Ltd.
- Enrollment
- 338
- Primary Endpoint
- Rate of Complete Dyspepsia Symptom Relief
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
The purpose of this study is to assess the efficacy and safety of rabeprazole compared to placebo in Japanese subjects with Functional Dyspepsia.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Rabeprazole 10 mg
Intervention: Rabeprazole
Rabeprazole 20 mg
Intervention: Rabeprazole
Rabeprazole 40 mg
Intervention: Rabeprazole
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Rate of Complete Dyspepsia Symptom Relief
Time Frame: Up to 8 Weeks (including 7 days prior)
The rate of complete dyspepsia symptom relief according to the Dyspepsia Symptom Questionnaire (DSQ) was defined as a score of 1 for all four major dyspeptic symptoms at week 8 and according to the diary defined as all four dyspepsia symptoms recorded absent during the 7 days prior to week 8. Values presented as percentage of participants.
Secondary Outcomes
- Rate of Satisfactory Symptom Relief(Up to 8 Weeks (including 7 days prior))
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