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NCT00394186 Clinical Trial

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

Irritable Bowel Syndrome (IBS) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00394186
Other study ID # B3I105940
Secondary ID
Status Completed
Phase Phase 2
First received October 27, 2006
Last updated May 15, 2009
Start date August 2006

Study information
Verified date May 2009
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority Australia: Department of Health and Ageing Therapeutic Goods Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Drug:
• GW427353

• Placebo

Locations
Country Name City State
Australia GSK Investigational Site Adelaide South Australia
Australia GSK Investigational Site Box Hill Victoria
Australia GSK Investigational Site Caboolture Queensland
Australia GSK Investigational Site Concord New South Wales
Australia GSK Investigational Site Kippa Ring Queensland
Australia GSK Investigational Site Malvern Victoria
Australia GSK Investigational Site Spring Hill Queensland
France GSK Investigational Site Issoire
France GSK Investigational Site Les Sables d'Olonne
France GSK Investigational Site Lille
France GSK Investigational Site Saint Quentin
France GSK Investigational Site Vitry sur Seine
Germany GSK Investigational Site Berlin
Germany GSK Investigational Site Berlin
Germany GSK Investigational Site Berlin
Germany GSK Investigational Site Hamburg
Germany GSK Investigational Site Hamburg
Germany GSK Investigational Site Leipzg Sachsen
Germany GSK Investigational Site Witten Nordrhein-Westfalen

Sponsors (1)
Lead Sponsor Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Australia,  France,  Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary completion of questionnaires by the subject, determining the average adequate relief rate during the last 4 weeks of the treatment periods (weeks 3 to 6 in period 1 and weeks 15-18 in period 2)
Secondary Blood levels of GW427353 Week 1, 13
Secondary Questionnaire Weeks 1, 6, 12, 18, 24
Secondary ECG, vital signs, adverse events each visit
Secondary clinical lab tests Weeks 1, 6, 12, 18, 24
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