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Effects Of GW876008 On The Bowel In Patients With Irritable Bowel Syndrome

This study has been completed.
Information provided by:
GlaxoSmithKline Identifier:
First received: October 4, 2006
Last updated: July 22, 2009
Last verified: July 2009
The purpose of this study is to see if GW876008 in Irritable Bowel Syndrome patients will reverse stress-induced hypersensitivity, by looking at thresholds for perception and pain.

Condition Intervention Phase
Irritable Bowel Syndrome (IBS)
Drug: GW876008
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Phase IIa, Single-centre, Randomised, Placebo-controlled, Double-blind, Three-period Crossover Study Investigating the Effects on Gut Autonomic Responses of Single Administrations of Either 20 mg or 200 mg GW876008, a CRF1 Antagonist, to Adult Patients With Irritable Bowel Syndrome

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Change in regional rectal mucosal blood flow in response to a cold water pressor test and in response to a listening test.

Secondary Outcome Measures:
  • Thresholds for rectal pain sensitivity

Enrollment: 10
Study Start Date: December 2006
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion criteria:

  • Must have irritable bowel syndrome.

Exclusion criteria:

  • Subjects who have been taking any medication for the treatment of irritable bowel syndrome within 6 months prior to the start of the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00385099

United Kingdom
GSK Investigational Site
London, United Kingdom, NW1 2BU
Sponsors and Collaborators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

Responsible Party: Study Director, GSK Identifier: NCT00385099     History of Changes
Other Study ID Numbers: CRI103143 
Study First Received: October 4, 2006
Last Updated: July 22, 2009
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by GlaxoSmithKline:

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases processed this record on September 29, 2016