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

This study has been completed.

First Received: October 27, 2006 Last Updated: May 15, 2009 History of Changes

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00394186

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 II

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Double-Blind, Crossover Assignment, Safety/Efficacy Study
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

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

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

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	B3I105940
Study First Received:	October 27, 2006
Last Updated:	May 15, 2009
ClinicalTrials.gov Identifier:	NCT00394186 History of Changes
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:

Neurotransmitter Agents
Disease
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Diseases
Physiological Effects of Drugs
Colonic Diseases
Intestinal Diseases

Pharmacologic Actions
Adrenergic Agonists
Digestive System Diseases
Pathologic Processes
Syndrome
Irritable Bowel Syndrome
Colonic Diseases, Functional

ClinicalTrials.gov processed this record on February 08, 2010