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

This study has been completed.

First Received: September 13, 2005 Last Updated: April 15, 2008 History of Changes

Sponsors and Collaborators:	Astellas Pharma Inc Astellas Pharma Europe BV
Information provided by:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00189813

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 II

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

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:	Astellas Pharma Europe BV ( Disclosure Office Europe )
Study ID Numbers:	060-CL-305
Study First Received:	September 13, 2005
Last Updated:	April 15, 2008
ClinicalTrials.gov Identifier:	NCT00189813 History of Changes
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

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