A Study to Evaluate Efficacy of YM060 on Diarrhea-predominant Irritable Bowel Syndrome (D-IBS) in Female Patients

October 9, 2015 updated by: Astellas Pharma Inc

Phase II Study of YM060 - Double-blind, Parallel-group Comparative Study in Patients (Female) With Diarrhea-predominant Irritable Bowel Syndrome

A study to verify the superiority of YM060 (ramosetron) to placebo for female patients with diarrhea-predominant irritable bowel syndrome (D-IBS) and to evaluate its safety.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

409

Phase

  • Phase 2

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
      • Kyusyu, 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:

  • Patients meeting the Rome III Diagnostic Criteria
  • Loose (mushy) or watery stools within the last 3 months
  • Abdominal discomfort and/or pain during their non-menstrual period

Exclusion Criteria:

  • Patients with a history of surgical resection of the stomach, small intestine or large intestine
  • Patients with a history or current diagnosis of inflammatory bowel disease (Crohn's disease or colitis ulcerative)
  • Patients with a history or current diagnosis of colitis ischemic
  • Patients with a current diagnosis of enteritis infectious
  • Patients with a current diagnosis of hyperthyroidism or hypothyroidism
  • Patients who are currently participating in another clinical trial (including a post-marketing clinical study) or those who participated in another clinical trial (including a post-marketing clinical study) within 12 weeks before the study
  • Patients with a history or current diagnosis of malignant tumor
  • Patients with a history of abuse of drugs or alcohol within 1 year or those who are currently abusing them

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 low-dose group
Drug: YM060
oral
Other Names:
  • ramosetron, Irribow
Experimental: YM060 middle-dose group
Drug: YM060
oral
Other Names:
  • ramosetron, Irribow
Experimental: YM060 high-dose group
Drug: YM060
oral
Other Names:
  • ramosetron, Irribow

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Responder rate of patients reported global assessment of relief of IBS symptoms
Time Frame: for 4 weeks
for 4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Responder rate of patients reported assessment of relief of abdominal discomfort and/or pain
Time Frame: for 4 weeks
for 4 weeks
Responder rate of patients reported assessment of improvement of abnormal bowel habits
Time Frame: for 4 weeks
for 4 weeks
Change in weekly average scores of stool form (appearance)
Time Frame: Baseline and for 4 weeks
Baseline and for 4 weeks
Safety assessed by the incidence of adverse events and abnormal values in lab-tests
Time Frame: for 4 weeks
for 4 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

November 1, 2010

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

January 5, 2011

First Submitted That Met QC Criteria

January 7, 2011

First Posted (Estimate)

January 11, 2011

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-701

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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