A Study To Investigate GW427353 In Subjects With Irritable Bowel Syndrome (IBS)
Phase 2
Completed
- Conditions
- Irritable Bowel Syndrome (IBS)
- Registration Number
- NCT00394186
- Lead Sponsor
- GlaxoSmithKline
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
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)
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Exclusion Criteria
- Subjects not meeting the Rome II criteria for the diagnosis of IBS
- Subjects with no stool for 7 days during the screen
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
GSK Investigational Site
🇩🇪Hamburg, Germany