A Study of E3810 for Japanese Subjects With Functional Dyspepsia (SAMURAI Study: Suppression of Acid Milieu With Rabeprazole Improving Functional Dyspepsia ) (Study E3810-J081-204)
- Registration Number
- NCT01089543
- Lead Sponsor
- Eisai Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 338
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Rabeprazole 10 mg Rabeprazole - Rabeprazole 20 mg Rabeprazole - Rabeprazole 40 mg Rabeprazole - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Rate of Complete Dyspepsia Symptom Relief 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 Outcome Measures
Name Time Method Rate of Satisfactory Symptom Relief Up to 8 Weeks (including 7 days prior) The rate of satisfactory symptom relief according to the DSQ defined as scores of \<= 2 for all four major dyspepsia symptoms at week 8 and the diary recordings defined as a frequency of \<= 1 day for all four major dyspepsia symptoms during the 7 days before week 8. Lastly, treatment success according to the participants' impression questionnaire where participants answered "yes" or "no" when asked if given the choice, whether they would want to continue to take the study drug after clinical trial completion. Values presented as percentage of participants.