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

Irritable Bowel Syndrome (IBS) Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00376896
• Other study ID #: CRI103147
• Status: Completed
• Phase: Phase 1
• First received: September 13, 2006
• Last updated: May 15, 2017
• Start date: November 2006
• Est. completion date: October 2008

Study information

• Verified date: May 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Irritable Bowel Syndrome (IBS)
• Irritable Colon
• Syndrome

Intervention

Drug:
• GW876008 200mcg
GW876008
• GW876008 20mcg
GW876008 20mcg

Other:
• Placebo
placebo

Locations

Country	Name	City	State
United States	GSK Investigational Site	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Signal reductions in the amygdala during viewing of emotional faces and during abdominal pain threat as measured by the fMRI.		throughout the study
Secondary	Questionnaires to assess IBS symptoms and anxiety		throughout the study