Status:
COMPLETED
Study On The Effect Of GW876008 On Cerebral Blood Flow In Irritable Bowel Syndrome (IBS) Patients And Healthy Volunteers
Lead Sponsor:
GlaxoSmithKline
Conditions:
Irritable Colon
Irritable Bowel Syndrome (IBS)
Eligibility:
FEMALE
18-65 years
Phase:
PHASE1
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00376896
Start Date
November 1 2006
End Date
October 1 2008
Last Update
May 16 2017
Active Locations (1)
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1
GSK Investigational Site
Los Angeles, California, United States, 90095