Phase 3 Study of YM060 in Patients With Diarrhea-predominant Irritable Bowel Syndrome (d-IBS)

Phase 3

Completed

• Conditions: Irritable Bowel Syndrome

• Registration Number: NCT00189696
• Lead Sponsor: Astellas Pharma Inc

Brief Summary

This study will examine the efficacy, safety and tolerability of oral dose of YM060, 5-HT3 receptor antagonist, in patients with d-IBS.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-19
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-09
• Last Update Posted: 2015-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Patients satisfying the Rome II Diagnostic Criteria.
• Patients in whom no organic changes were observed in large intestine.

Exclusion Criteria

• Patients have diseases which interfere with evaluation of the efficacy and safety in this study.
• Patients are receiving and/or have received prior to the enrollment the treatment which interfere with evaluation of the efficacy and safety in this study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL