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

August 27, 2014 updated by: Astellas Pharma Inc

A Randomized, Double-blind, Placebo-controlled Study to Investigate the Potential Efficacy, Safety and Tolerability of Different Oral Doses of YM060 in Patients With Diarrhea-predominant Irritable Bowel Syndrome

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

691

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

  • Bulgaria
      • Plovdiv, Bulgaria
      • Sofia, Bulgaria
      • Varna, Bulgaria
  • Czech Republic
      • Ceske Budejovice, Czech Republic
      • Hradec Kralove, Czech Republic
      • Ostrava Hrabuvka, Czech Republic
      • Praha, Czech Republic
      • Tabor, Czech Republic
      • Usti nad Orlici, Czech Republic
  • Estonia
      • Tallinn, Estonia
      • Tartu, Estonia
      • Viljandi, Estonia
  • Germany
      • Berlin, Germany
      • Bochum, Germany
      • Dietzenbach, Germany
      • Essen, Germany
      • Frankfurt, Germany
      • Friedberg, Germany
      • Hamburg, Germany
      • Hassloch, Germany
      • Koenigstein, Germany
      • Leipzig, Germany
      • Mainz, Germany
      • Marburg, Germany
      • Potsdam, Germany
      • Waltershausen, Germany
  • Lithuania
      • Kaunas, Lithuania
      • Klaipeda, Lithuania
      • Vilnius, Lithuania
  • Poland
      • Bialystok, Poland
      • Bydgoszcz, Poland
      • Krakow, Poland
      • Leszno, Poland
      • Lublin, Poland
      • Olawa, Poland
      • Warszawa, Poland
  • Russian Federation
      • Moscow, Russian Federation
      • St. Petersburg, Russian Federation
      • Yaroslavl, Russian Federation
  • Ukraine
      • Dnipropetrovsk, Ukraine
      • Kiev, Ukraine
      • Lviv, Ukraine
      • Odessa, Ukraine
      • Simferopol, Ukraine
      • Sumy, Ukraine

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

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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

Collaborators

Astellas Pharma Europe B.V.

Investigators

  • Study Chair: F. Verbeeck, Director of Late Phase Development

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.

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

March 1, 2005

Primary Completion (Actual)

December 1, 2005

Study Completion (Actual)

December 1, 2005

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 19, 2005

Study Record Updates

Last Update Posted (Estimate)

August 28, 2014

Last Update Submitted That Met QC Criteria

August 27, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 060-CL-305

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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