A Study To Investigate GW427353 In Subjects With Irritable Bowel Syndrome (IBS)
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
1 other identifier
interventional
100
3 countries
19
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2006
CompletedFirst Submitted
Initial submission to the registry
October 27, 2006
CompletedFirst Posted
Study publicly available on registry
October 31, 2006
CompletedMay 18, 2009
May 1, 2009
October 27, 2006
May 15, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Blood levels of GW427353
Week 1, 13
Questionnaire
Weeks 1, 6, 12, 18, 24
ECG, vital signs, adverse events
each visit
clinical lab tests
Weeks 1, 6, 12, 18, 24
Interventions
Eligibility Criteria
You may qualify if:
- \- Diagnosis of IBS which meets the Rome II criteria, screening pain score to be \> 1.5 (0= no pain, 4 = very severe pain)
You may not qualify if:
- Subjects not meeting the Rome II criteria for the diagnosis of IBS
- Subjects with no stool for 7 days during the screen
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (19)
GSK Investigational Site
Concord, New South Wales, 2139, Australia
GSK Investigational Site
Caboolture, Queensland, 4510, Australia
GSK Investigational Site
Kippa-Ring, Queensland, 4021, Australia
GSK Investigational Site
Spring Hill, Queensland, 4000, Australia
GSK Investigational Site
Adelaide, South Australia, 5000, Australia
GSK Investigational Site
Box Hill, Victoria, 3128, Australia
GSK Investigational Site
Malvern, Victoria, 3144, Australia
GSK Investigational Site
Issoire, 63500, France
GSK Investigational Site
Les Sables-d'Olonne, 85100, France
GSK Investigational Site
Lille, 59000, France
GSK Investigational Site
Saint-Quentin, 02100, France
GSK Investigational Site
Vitry-sur-Seine, 94400, France
GSK Investigational Site
Hamburg, Hamburg, 20249, Germany
GSK Investigational Site
Hamburg, Hamburg, 22143, Germany
GSK Investigational Site
Witten, North Rhine-Westphalia, 58455, Germany
GSK Investigational Site
Leipzg, Saxony, 04109, Germany
GSK Investigational Site
Berlin, State of Berlin, 10629, Germany
GSK Investigational Site
Berlin, State of Berlin, 10787, Germany
GSK Investigational Site
Berlin, State of Berlin, 13125, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials, MD
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- DIAGNOSTIC
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 27, 2006
First Posted
October 31, 2006
Study Start
August 1, 2006
Last Updated
May 18, 2009
Record last verified: 2009-05