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Clinical Trials/NCT00394186
NCT00394186
Completed
Phase 2

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

GlaxoSmithKline1 site in 1 country100 target enrollmentAugust 2006
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ConditionsIrritable Bowel Syndrome (IBS)
DrugsGW427353Placebo

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Irritable Bowel Syndrome (IBS)
Sponsor
GlaxoSmithKline
Enrollment
100
Locations
1
Primary Endpoint
completion of questionnaires by the subject, determining the average adequate relief rate
Status
Completed
Last Updated
16 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2006
End Date
TBD
Last Updated
16 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Eligibility 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

Outcomes

Primary Outcomes

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 Outcomes

  • clinical lab tests(Weeks 1, 6, 12, 18, 24)
  • Blood levels of GW427353(Week 1, 13)
  • Questionnaire(Weeks 1, 6, 12, 18, 24)
  • ECG, vital signs, adverse events(each visit)

Study Sites (1)

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