Phase 2
N=338
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)
Functional Dyspepsia
Bottom Line
View on ClinicalTrials.gov: NCT01089543 ↗Enrolled (actual)
338
Serious AEs
0.9%
Results posted
Nov 2013
Primary outcome: Primary: Rate of Complete Dyspepsia Symptom Relief — 22.4; 29.3; 27.0; 17.9 Percentage of Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Rabeprazole (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Eisai Co., Ltd.
- Primary completion
- Aug 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Complete Dyspepsia Symptom Relief |
22.4; 29.3; 27.0; 17.9; 22.1; 28.9 | — |
| SECONDARY Rate of Satisfactory Symptom Relief |
42.1; 45.3; 39.2; 28.2; 37.7; 48.7 | — |
Summary
The purpose of this study is to assess the efficacy and safety of rabeprazole compared to placebo in Japanese subjects with Functional Dyspepsia.
Eligibility Criteria
Inclusion criteria
-Participants diagnosed as Functional Dyspepsia according to Rome III criteria.
Exclusion criteria
- Participants with neuropsychiatric disorder.
- Participants diagnosed with irritable bowel syndrome, inflammatory bowel disease and serious constipation.
Data sourced from ClinicalTrials.gov (NCT01089543). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.