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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00394186
First received: October 27, 2006
Last updated: May 15, 2009
Last verified: May 2009
  Purpose

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 Intervention Phase
Irritable Bowel Syndrome (IBS)
Drug: GW427353
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
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

Further study details as provided by GlaxoSmithKline:

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

Enrollment: 100
Study Start Date: August 2006
Intervention Details:
    Drug: GW427353 Drug: Placebo
    Other Names:
    • GW427353
    • Placebo
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00394186

Locations
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
France
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
Germany
GSK Investigational Site
Witten, Nordrhein-Westfalen, Germany, 58455
GSK Investigational Site
Leipzg, Sachsen, Germany, 04109
GSK Investigational Site
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
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00394186     History of Changes
Other Study ID Numbers: B3I105940
Study First Received: October 27, 2006
Last Updated: May 15, 2009
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by GlaxoSmithKline:
GW427353
b3-Adrenergic Receptor Agonist
Irritable Bowel Syndrome (IBS)
efficacy
tolerability
pharmacokinetics

Additional relevant MeSH terms:
Syndrome
Irritable Bowel Syndrome
Disease
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Solabegron
Adrenergic Agonists
Adrenergic beta-3 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 30, 2014