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

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