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

October 9, 2015 updated by: Astellas Pharma Inc

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

Study Overview

Status

Completed

Conditions

Irritable Bowel Syndrome

Intervention / Treatment

Drug: YM060

Study Type

Interventional

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Japan
- - Chubu region, Japan
  - Kanto region, Japan
  - Shikoku region, Japan
  - Tohoku Region, Japan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 64 years (Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Investigators

Study Chair: Study Director, Clinical Development III, Astellas Pharma Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Matsueda K, Harasawa S, Hongo M, Hiwatashi N, Sasaki D. A randomized, double-blind, placebo-controlled clinical trial of the effectiveness of the novel serotonin type 3 receptor antagonist ramosetron in both male and female Japanese patients with diarrhea-predominant irritable bowel syndrome. Scand J Gastroenterol. 2008;43(10):1202-11. doi: 10.1080/00365520802240255.

Helpful Links

Link to results on Astellas Clinical Study Results Web site

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 19, 2005

Study Record Updates

Last Update Posted (Estimate)

October 12, 2015

Last Update Submitted That Met QC Criteria

October 9, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Irritable Bowel Syndrome, Diarrhea

Additional Relevant MeSH Terms

Other Study ID Numbers

060-CL-202

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.