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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00394186
Recruitment Status : Completed
First Posted : October 31, 2006
Last Update Posted : May 18, 2009
Information provided by:

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome (IBS) Drug: GW427353 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Diagnostic
Official Title: 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
Study Start Date : August 2006

Intervention Details:
  • Drug: GW427353
  • Drug: Placebo
    Other Name: GW427353

Primary Outcome Measures :
  1. 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) ]

Secondary Outcome Measures :
  1. Blood levels of GW427353 [ Time Frame: Week 1, 13 ]
  2. Questionnaire [ Time Frame: Weeks 1, 6, 12, 18, 24 ]
  3. ECG, vital signs, adverse events [ Time Frame: each visit ]
  4. clinical lab tests [ Time Frame: Weeks 1, 6, 12, 18, 24 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00394186

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Australia, New South Wales
GSK Investigational Site
Concord, New South Wales, Australia, 2139
Australia, Queensland
GSK Investigational Site
Caboolture, Queensland, Australia, 4510
GSK Investigational Site
Kippa Ring, Queensland, Australia, 4021
GSK Investigational Site
Spring Hill, Queensland, Australia, 4000
Australia, South Australia
GSK Investigational Site
Adelaide, South Australia, Australia, 5000
Australia, Victoria
GSK Investigational Site
Box Hill, Victoria, Australia, 3128
GSK Investigational Site
Malvern, Victoria, Australia, 3144
GSK Investigational Site
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
Witten, Nordrhein-Westfalen, Germany, 58455
GSK Investigational Site
Leipzg, Sachsen, Germany, 04109
GSK Investigational Site
Berlin, Germany, 10629
GSK Investigational Site
Berlin, Germany, 10787
GSK Investigational Site
Berlin, Germany, 13125
GSK Investigational Site
Hamburg, Germany, 20249
GSK Investigational Site
Hamburg, Germany, 22143
Sponsors and Collaborators
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Study Director: GSK Clinical Trials, MD GlaxoSmithKline

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Responsible Party: Study Director, GSK Identifier: NCT00394186     History of Changes
Other Study ID Numbers: B3I105940
First Posted: October 31, 2006    Key Record Dates
Last Update Posted: May 18, 2009
Last Verified: May 2009
Keywords provided by GlaxoSmithKline:
b3-Adrenergic Receptor Agonist
Irritable Bowel Syndrome (IBS)
Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic beta-3 Receptor Agonists
Adrenergic beta-Agonists