A Study of YM060 in Diarrhea-predominant Irritable Bowel Syndrome (d-IBS)
Overview
This study will examine the efficacy, safety and tolerability of different oral dose of YM060, 5-HT3 receptor antagonist, in patients with d-IBS.
Full Title of Study: “A Randomized, Double-blind, Placebo-controlled Study to Investigate the Potential Efficacy, Safety and Tolerability of Different Oral Doses of YM060 in Patients With Diarrhea-predominant Irritable Bowel Syndrome”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Double
- Study Primary Completion Date: December 2005
Interventions
- Drug: YM060
Participating in This Clinical Trial
Inclusion Criteria
- Patient meets Rome II criteria for IBS and the subgroup of diarrhea predominant IBS 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
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 70 Years
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Astellas Pharma Inc
- Collaborator
- Astellas Pharma Europe B.V.
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- F. Verbeeck, Study Chair, Director of Late Phase Development
Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.