A Study to Assess the Efficacy and Safety of YM060 in Female Patients With Diarrhea-predominant Irritable Bowel Syndrome (IBS)

October 9, 2015 updated by: Astellas Pharma Inc

A Double-blind, Parallel-group, Comparative Study in Female Patients With Diarrhea-predominant Irritable Bowel Syndrome

To demonstrate the superiority of YM060 to a placebo in global assessment of relief of overall IBS symptoms and stool form normalization, and to evaluate safety in female patients with diarrhea-predominant irritable bowel syndrome (D-IBS).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

577

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
      • Hokkaido, Japan
      • Kansai, Japan
      • Kantou, Japan
      • Kyushu, 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

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Patients satisfying the Rome III Diagnostic Criteria
  2. Patients whose ≥25% of stools were loose or watery and <25% of them were hard or lumpy stools
  3. Patients who have abdominal pain or discomfort
  4. Patients in whom after occurrence of IBS symptoms the following tests were conducted and in whom no organic changes were observed Pancolonoscopy or contrast enema

Exclusion Criteria:

  1. Patients with a history of surgical resection of the stomach, gallbladder, small intestine or large intestine
  2. Patients with a history or current evidence of inflammatory bowel disease
  3. Patients with a history or current evidence of colitis ischemic
  4. Patients with concurrent infectious enteritis
  5. Patients with concurrent hyperthyroidism or hypothyroidism
  6. Patients with concurrent active peptic ulcer
  7. Patients with other concurrent disease that may affect the digestive tract passage or large intestinal function or that is likely to interfere with proper assessment of IBS abdominal pain/discomfort

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo group
Drug: Placebo
oral
Experimental: YM060 group
Drug: YM060
oral
Other Names:
  • Irribow
  • ramosetron,

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Monthly responder rate of global assessment of relief of overall IBS symptoms at final point
Time Frame: Up to 12 weeks
Up to 12 weeks
Monthly responder rate of stool form normalization at final point
Time Frame: Up to 12 weeks
Up to 12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Monthly responder rate of global assessment of relief of abdominal pain/discomfort
Time Frame: Up to 12 weeks
Up to 12 weeks
Monthly responder rate of global assessment of improvement of abnormal bowel habits
Time Frame: Up to 12 weeks
Up to 12 weeks
Change in weekly average scores of severity of abdominal pain/discomfort
Time Frame: Up to 12 weeks
Up to 12 weeks
Change in weekly average scores of stool form
Time Frame: Up to 12 weeks
Up to 12 weeks
Safety assessment of YM060
Time Frame: Up to 12 weeks
Up to 12 weeks

Collaborators and Investigators

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

Sponsor

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

Helpful Links

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 Major Dates

Study Start

February 1, 2013

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

June 4, 2013

First Submitted That Met QC Criteria

June 4, 2013

First Posted (Estimate)

June 6, 2013

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 060-CL-702

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.

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