Last reviewed · How we verify
Post-marketing Clinical Study of Ramosetron Hydrochloride (Irribow Tablets) - A Preliminary Study to Evaluate the Co-primary Endpoint in Patients (Male) With Diarrhea-predominant Irritable Bowel Syndrome
The purpose of this study is to explore and examine endpoints that allow evaluation of the "clinically significant improvements, focusing on the patient's chief complaint and the severity of major IBS symptoms" by this drug in patients with diarrhea-predominant irritable bowel syndrome (IBS).
Details
| Lead sponsor | Astellas Pharma Inc |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 98 |
| Start date | 2009-06 |
| Completion | 2009-12 |
Conditions
- Irritable Bowel Syndrome
Interventions
- Ramosetron
- Placebo
Primary outcomes
- IBS severity index (Japanese version) — 12 weeks
Countries
Japan