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

This study has been completed.
Information provided by (Responsible Party):
Astellas Pharma Inc Identifier:
First received: September 12, 2005
Last updated: October 9, 2015
Last verified: October 2015
This study will examine the efficacy, safety and tolerability of oral dose of YM060, 5-HT3 receptor antagonist, in patients with d-IBS.

Condition Intervention Phase
Irritable Bowel Syndrome
Drug: YM060
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Astellas Pharma Inc:


Ages Eligible for Study:   20 Years to 64 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00189696

Chubu region, Japan
Kanto region, Japan
Shikoku region, Japan
Tohoku Region, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Study Chair: Study Director, Clinical Development III Astellas Pharma Inc
  More Information

Additional Information:
Responsible Party: Astellas Pharma Inc Identifier: NCT00189696     History of Changes
Other Study ID Numbers: 060-CL-202 
Study First Received: September 12, 2005
Last Updated: October 9, 2015
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Astellas Pharma Inc:
Irritable Bowel Syndrome, Diarrhea

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action processed this record on October 21, 2016