A Preliminary Study to Explore Clinical Endpoints in Patients (Male) With Diarrhea-predominant Irritable Bowel Syndrome

This study has been completed.

Sponsor:

Information provided by:

Astellas Pharma Inc

ClinicalTrials.gov Identifier:

NCT00918411

First received: June 9, 2009

Last updated: January 21, 2010

Last verified: January 2010

History of Changes

Purpose

The purpose of this study is to explore and examine endpoints that allow evaluation of the "clinically significant improvements, focusing on the patient's chief complaint and the severity of major IBS symptoms" by this drug in patients with diarrhea-predominant irritable bowel syndrome (IBS).

Condition	Intervention	Phase
Irritable Bowel Syndrome	Drug: Ramosetron Drug: Placebo	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject)
Official Title:	Post-marketing Clinical Study of Ramosetron Hydrochloride (Irribow Tablets) - A Preliminary Study to Evaluate the Co-primary Endpoint in Patients (Male) With Diarrhea-predominant Irritable Bowel Syndrome

Resource links provided by NLM:

MedlinePlus related topics: Diarrhea

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:

IBS severity index (Japanese version) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Patient reported global assessment of relief of IBS symptoms [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Patient reported assessment of relief of abdominal discomfort and/or pain [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Patient reported assessment of improvement of abdominal bowel habits [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]


Enrollment:	98
Study Start Date:	June 2009
Study Completion Date:	December 2009
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Ramosetron group oral	Drug: Ramosetron oral Other Names: Irribow YM060
Placebo Comparator: Placebo group oral	Drug: Placebo oral

Eligibility


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

Criteria

Inclusion Criteria:

Patients meeting the Rome III Diagnostic Criteria
Loose (mushy) or watery stools within the last 3 months

Exclusion Criteria:

Patients having hyperthyroidism or hypothyroidism

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00918411

Locations


Japan

Hokkaido, Japan

Kansai, Japan

Kantou, Japan

Kyusyu, Japan

Sponsors and Collaborators

Astellas Pharma Inc

Investigators


Study Chair:	Use Central Contact	Astellas Pharma Inc

More Information

No publications provided


Responsible Party:	Director, Astellas Pharma, Inc
ClinicalTrials.gov Identifier:	NCT00918411 History of Changes
Other Study ID Numbers:	060-CL-500
Study First Received:	June 9, 2009
Last Updated:	January 21, 2010
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Astellas Pharma Inc:


diarrhea IBS Colonic diseases YM060

Additional relevant MeSH terms:


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

ClinicalTrials.gov processed this record on February 27, 2015

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