A Study To Investigate GW427353 In Subjects With Irritable Bowel Syndrome (IBS)

May 15, 2009 updated by: GlaxoSmithKline

A Randomized, Double-Blind, Placebo-Controlled, Crossover, Phase IIa Study to Evaluate Efficacy and Safety of the Beta-3-Adrenergic Receptor Agonist Solabegron in Subjects With Irritable Bowel Syndrome

This study will test the hypothesis that GW427353, a beta-3 adrenergic agonist, will relieve IBS pain or discomfort and associated symptoms in IBS patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

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

  • Australia
    • New South Wales
      • Concord, New South Wales, Australia, 2139
        • GSK Investigational Site
    • Queensland
      • Caboolture, Queensland, Australia, 4510
        • GSK Investigational Site
      • Kippa Ring, Queensland, Australia, 4021
        • GSK Investigational Site
      • Spring Hill, Queensland, Australia, 4000
        • GSK Investigational Site
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • GSK Investigational Site
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • GSK Investigational Site
      • Malvern, Victoria, Australia, 3144
        • GSK Investigational Site
  • France
      • Issoire, France, 63500
        • GSK Investigational Site
      • Les Sables d'Olonne, France, 85100
        • GSK Investigational Site
      • Lille, France, 59000
        • GSK Investigational Site
      • Saint Quentin, France, 02100
        • GSK Investigational Site
      • Vitry sur Seine, France, 94400
        • GSK Investigational Site
  • Germany
      • Berlin, Germany, 13125
        • GSK Investigational Site
      • Berlin, Germany, 10629
        • GSK Investigational Site
      • Berlin, Germany, 10787
        • GSK Investigational Site
      • Hamburg, Germany, 22143
        • GSK Investigational Site
      • Hamburg, Germany, 20249
        • GSK Investigational Site
    • Nordrhein-Westfalen
      • Witten, Nordrhein-Westfalen, Germany, 58455
        • GSK Investigational Site
    • Sachsen
      • Leipzg, Sachsen, Germany, 04109
        • GSK Investigational Site

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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

- Diagnosis of IBS which meets the Rome II criteria, screening pain score to be > 1.5 (0= no pain, 4 = very severe pain)

Exclusion Criteria:

  • Subjects not meeting the Rome II criteria for the diagnosis of IBS
  • Subjects with no stool for 7 days during the screen

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: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
completion of questionnaires by the subject, determining the average adequate relief rate
Time Frame: during the last 4 weeks of the treatment periods (weeks 3 to 6 in period 1 and weeks 15-18 in period 2)
during the last 4 weeks of the treatment periods (weeks 3 to 6 in period 1 and weeks 15-18 in period 2)

Secondary Outcome Measures

Outcome Measure
Time Frame
Blood levels of GW427353
Time Frame: Week 1, 13
Week 1, 13
Questionnaire
Time Frame: Weeks 1, 6, 12, 18, 24
Weeks 1, 6, 12, 18, 24
ECG, vital signs, adverse events
Time Frame: each visit
each visit
clinical lab tests
Time Frame: Weeks 1, 6, 12, 18, 24
Weeks 1, 6, 12, 18, 24

Collaborators and Investigators

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

Sponsor

GlaxoSmithKline

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

August 1, 2006

Study Registration Dates

First Submitted

October 27, 2006

First Submitted That Met QC Criteria

October 30, 2006

First Posted (Estimate)

October 31, 2006

Study Record Updates

Last Update Posted (Estimate)

May 18, 2009

Last Update Submitted That Met QC Criteria

May 15, 2009

Last Verified

May 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B3I105940

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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