Study On The Effect Of GW876008 On Cerebral Blood Flow In Irritable Bowel Syndrome (IBS) Patients And Healthy Volunteers - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00376896

Purpose

This is a three-period crossover study to compare GW876008 and placebo to see if GW876008 will normalise blood flow responses after different emotional stimuli.

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

Drug Information available for: Corticotropin Corticotropin-releasing hormone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Crossover Assignment, Pharmacodynamics Study
Official Title:	A Phase IIa Experimental Medicine Study Assessing Alterations in Regional Cerebral Blood Flow by Functional Magnetic Resonance Imaging (fMRI) in Female IBS Patients and Healthy Controls Following Single Doses of GW876008, a Corticotrophin Releasing Factor 1 Receptor Antagonist (CRF1-RA)

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Signal reductions in the amygdala during viewing of emotional faces and during abdominal pain threat as measured by the fMRI. [ Time Frame: throughout the study ]

Secondary Outcome Measures:

Questionnaires to assess IBS symptoms and anxiety [ Time Frame: throughout the study ]

Estimated Enrollment:	40
Study Start Date:	November 2006

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

The subject should not have been taking and medication for the treatment of IBS for 1 month prior to the study
Negative serum pregnancy tests (serum a-HCG negative) at Screening (Visit 1), and negative urine pregnancy tests at Visits 1, 2, 3 prior to study medication dose.
Non-tobacco user (abstinence from tobacco use for at least 1 month before the start of the study).
Normal electrocardiogram (subjects must have no clinically significant abnormalities on a 12-lead ECG at screen).

Exclusion Criteria:

Subjects who are pregnant or nursing.
Current evidence, or history of (at any time in the past) of a biochemical or structural abnormality of the digestive tract. including (but not limited to): inflammatory bowel disease (Crohn's disease or ulcerative colitis); functional dyspepsia; lactose intolerance, not on a stable diet; Celiac Disease
Subjects who are taking NSAIDs on a regular basis or within 48 hours of a study day.
The subject has a positive pre-study urine drug/alcohol screen.
A positive pre-study HIV 1 / 2, Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of the start of the study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00376896

Locations

United States, California
GSK Investigational Site
Los Angeles, California, United States, 90095

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, Dr

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	CRI103147
Study First Received:	September 13, 2006
Last Updated:	October 15, 2008
ClinicalTrials.gov Identifier:	NCT00376896
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

IBS fMRI

Study placed in the following topic categories:

Digestive System Diseases
Corticotropin-Releasing Hormone
Gastrointestinal Diseases
Colonic Diseases
Irritable Bowel Syndrome

Healthy
Intestinal Diseases
Colonic Diseases, Functional
Adrenocorticotropic Hormone

Additional relevant MeSH terms:

Pathologic Processes
Disease
Syndrome
Physiological Effects of Drugs

Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009