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Solabegron for Irritable Bowel Syndrome
NCT00394186Phase 2
Key facts
- Status
- Completed
- Start
- Aug 2006
- Countries
- 3
- Sponsor
- GSK
- Modality
- Small Molecules
- Drugs
- Solabegron
- Conditions
- irritable bowel syndrome (IBS)
01
Overview
Phase 2, randomised, double-blind trial of Solabegron in irritable bowel syndrome (IBS) (2 arms), sponsored by GSK. Primary endpoint: Average adequate relief rate based on subject questionnaires at 18 weeks. Started Aug 2006; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Sequence A
Solabegron followed by Placebo
Sequence B
Placebo followed by Solabegron
03
Who it enrols
Patients must have a diagnosis of Irritable Bowel Syndrome (IBS) according to the Rome II criteria, with a screening pain score of more than 1.5 on a 0-4 scale. Patients are excluded if they have severe constipation defined as no stool for 7 consecutive days during screening.
04
Endpoints
Primary
Average adequate relief rate based on subject questionnaires
Secondary
Blood levels of GW427353
Questionnaire
ECG, vital signs, adverse events
Clinical lab tests
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