Trial record 4 of 15 for:    crf1

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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00385099
First received: October 4, 2006
Last updated: July 22, 2009
Last verified: July 2009
  Purpose

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)
Intervention Details:
    Drug: GW876008
    Other Name: GW876008
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00385099

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

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov 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:
IBS
CRF1
stress

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on April 17, 2014