A Study of YM060 in Diarrhea-predominant Irritable Bowel Syndrome (d-IBS)

Phase 2

Completed

• Conditions: Irritable Bowel Syndrome

• Registration Number: NCT00189813
• Lead Sponsor: Astellas Pharma Inc

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2005-03
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-19
• Primary Completion: 2005-12
• Study Completion: 2005-12
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-27
• Last Update Posted: 2014-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 691

Inclusion Criteria

• Patient meets Rome II criteria for IBS and the subgroup of diarrhea predominant IBS

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Exclusion Criteria

• Patient with severe cardiovascular disease, respiratory diseases, renal diseases, hepatic diseases, digestive tract diseases (excluding IBS), blood diseases, or neurological or psychiatric diseases
• Patient reported having any Type 1 or Type 2 stool on the Bristol Stool Form Scale during the run-in period

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL