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

NCT ID: NCT00394186

Last Updated: 2009-05-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Irritable Bowel Syndrome (IBS)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Interventions

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GW427353

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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GW427353

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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GSK

Principal Investigators

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GSK Clinical Trials, MD

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Concord, New South Wales, Australia

Site Status

GSK Investigational Site

Caboolture, Queensland, Australia

Site Status

GSK Investigational Site

Kippa-Ring, Queensland, Australia

Site Status

GSK Investigational Site

Spring Hill, Queensland, Australia

Site Status

GSK Investigational Site

Adelaide, South Australia, Australia

Site Status

GSK Investigational Site

Box Hill, Victoria, Australia

Site Status

GSK Investigational Site

Malvern, Victoria, Australia

Site Status

GSK Investigational Site

Issoire, , France

Site Status

GSK Investigational Site

Les Sables-d'Olonne, , France

Site Status

GSK Investigational Site

Lille, , France

Site Status

GSK Investigational Site

Saint-Quentin, , France

Site Status

GSK Investigational Site

Vitry-sur-Seine, , France

Site Status

GSK Investigational Site

Hamburg, City state of Hamburg, Germany

Site Status

GSK Investigational Site

Hamburg, City state of Hamburg, Germany

Site Status

GSK Investigational Site

Witten, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Leipzg, Saxony, Germany

Site Status

GSK Investigational Site

Berlin, State of Berlin, Germany

Site Status

GSK Investigational Site

Berlin, State of Berlin, Germany

Site Status

GSK Investigational Site

Berlin, State of Berlin, Germany

Site Status

Countries

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Australia France Germany

Other Identifiers

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B3I105940

Identifier Type: -

Identifier Source: org_study_id

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