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Clinical Trials/NCT01089543
NCT01089543
Completed
Phase 2

A Multi-Center, Randomized, Double-Blind Study of E3810 for Japanese Subjects With Functional Dyspepsia

Eisai Co., Ltd.0 sites338 target enrollmentApril 2010

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.

Registry
clinicaltrials.gov
Start Date
April 2010
End Date
August 2011
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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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