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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Irritable Bowel Syndrome (IBS)

Treatments: Drug: Placebo; Drug: GW427353

Study type: Interventional

Funder types: Industry

Identifiers

NCT00394186

B3I105940

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind