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

GlaxoSmithKline100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

DOUBLE

Enrollment

100

Conditions

Irritable Bowel Syndrome (IBS)

Interventions

GW427353DRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (19)

GSK Investigational Site

Concord, New South Wales, Australia

GSK Investigational Site

Caboolture, Queensland, Australia

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

Blood levels of GW427353

Time frame: Week 1, 13

Questionnaire

Time frame: Weeks 1, 6, 12, 18, 24

ECG, vital signs, adverse events

Time frame: each visit

clinical lab tests

Time frame: Weeks 1, 6, 12, 18, 24

Data from ClinicalTrials.gov

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