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Completed

NCT Number: NCT00394186

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.

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Key information

Conditions

Irritable Bowel Syndrome (IBS) Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Irritable Bowel Syndrome

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

GSK Investigational Site, Concord, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GW427353

Drug

Placebo

Drug

Other names: GW427353

Primary outcomes

  1. 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

  1. Blood levels of GW427353

    Time frame: Week 1, 13

  2. Questionnaire

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

  3. ECG, vital signs, adverse events

    Time frame: each visit

  4. clinical lab tests

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

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Important dates

Study start
2006
First posted
Oct 31, 2006
Registry last updated
May 18, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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