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

This study has been completed.

First Received: September 12, 2005 Last Updated: September 25, 2006 History of Changes

Sponsored by:	Astellas Pharma Inc
Information provided by:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00189696

Purpose

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 III

MedlinePlus related topics: Diarrhea

Drug Information available for: Ramosetron YM 060

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Eligibility

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

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00189696

Locations

Japan

Tohoku Region, Japan

Kanto region, Japan

Chubu region, Japan

Shikoku region, Japan

Sponsors and Collaborators

Astellas Pharma Inc

Investigators

Study Chair:

Study Director, Clinical Development III

Astellas Pharm. Inc.

More Information

No publications provided

Study ID Numbers:	060-CL-202
Study First Received:	September 12, 2005
Last Updated:	September 25, 2006
ClinicalTrials.gov Identifier:	NCT00189696 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Astellas Pharma Inc:

Irritable Bowel Syndrome, Diarrhea

Study placed in the following topic categories:

Neurotransmitter Agents
Digestive System Diseases
Diarrhea
Gastrointestinal Diseases
Colonic Diseases
Irritable Bowel Syndrome

Antiemetics
Ramosetron
Peripheral Nervous System Agents
Intestinal Diseases
Colonic Diseases, Functional
Serotonin

Additional relevant MeSH terms:

Neurotransmitter Agents
Disease
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Diseases
Physiological Effects of Drugs
Colonic Diseases
Gastrointestinal Agents
Ramosetron
Antiemetics
Intestinal Diseases
Pharmacologic Actions

Serotonin Antagonists
Serotonin Agents
Digestive System Diseases
Pathologic Processes
Autonomic Agents
Therapeutic Uses
Syndrome
Irritable Bowel Syndrome
Peripheral Nervous System Agents
Central Nervous System Agents
Colonic Diseases, Functional

ClinicalTrials.gov processed this record on May 07, 2009