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

This study has been completed.
Sponsor:
Collaborator:
Astellas Pharma Europe BV
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00189813
First received: September 13, 2005
Last updated: April 15, 2008
Last verified: April 2008
History of Changes
  Purpose

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


Condition Intervention Phase
Irritable Bowel Syndrome
 Drug: YM060
 Phase 2

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:

MedlinePlus related topics: Diarrhea
U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Enrollment: 691
Study Completion Date: January 2006
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00189813

  Show 45 Study Locations
Sponsors and Collaborators
Astellas Pharma Inc
Astellas Pharma Europe BV
Investigators
Study Chair: F. Verbeeck Director of Late Phase Development
  More Information

No publications provided

Responsible Party: Disclosure Office Europe, Astellas Pharma Europe BV
ClinicalTrials.gov Identifier: NCT00189813     History of Changes
Other Study ID Numbers: 060-CL-305
Study First Received: September 13, 2005
Last Updated: April 15, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Czech Republic: State Institute for Drug Control
Bulgaria: Bulgarian Drug Agency
Estonia: The State Agency of Medicine
Lithuania: State Medicine Control Agency - Ministry of Health
Poland: Ministry of Health
Russia: Pharmacological Committee, Ministry of Health
Ukraine: State Pharmacological Center - Ministry of Health

Keywords provided by Astellas Pharma Inc:
Irritable Bowel Syndrome
Diarrhea

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Ramosetron
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013