NCT00918411

A Preliminary Study to Explore Clinical Endpoints in Patients (Male) With Diarrhea-predominant Irritable Bowel Syndrome

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 98 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: Male
• Age: 20 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• Irritable Bowel Syndrome

Interventions

Type	Name	Description
DRUG	Ramosetron	oral
DRUG	Placebo	oral

Timeline

• Start date: 2009-06-01
• Primary completion: 2009-12-01
• Completion: 2009-12-01
• First posted: 2009-06-11
• Last updated: 2015-10-12

Locations

4 sites across 1 country: Japan