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

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.

Official Title

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

Conditions

Irritable Bowel Syndrome

Study Type

Interventional

Study Design

Diagnostic, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study

Further Details

Primary Outcome Measures:

• 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:

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

Study Start

August 2006

Eligibility & Criteria

• Ages Eligible for Study: 18 Years – 65 Years
• Genders Eligible for Study: Both

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

Total Enrolment

100

Contact Details

Australian Locations:

• Concord, New South Wales, NSW 2139, Australia
• Brisbane, Queensland, QLD 4000, Australia
• Kippa Ring, Queensland, QLD 4021, Australia
• Caboolture, Queensland, QLD 4510, Australia
• Adelaide, South Australia, SA 5000, Australia
• Malvern, Victoria, VIC 3144, Australia
• Box Hill, Victoria, VIC 3128, Australia

For more information, contact GlaxoSmithKline