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

Phase 1

Completed

• Conditions: Irritable Colon; Irritable Bowel Syndrome (IBS)
• Interventions: Other: Placebo; Drug: GW876008 20mcg; Drug: GW876008 200mcg

• Registration Number: NCT00376896
• Lead Sponsor: GlaxoSmithKline

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-09-13
• Study First Submitted QC: 2006-09-13
• Study First Posted: 2006-09-15
• Study Start: 2006-11
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-15
• Last Update Posted: 2017-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 25

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).

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo
GW876008 20mcg	GW876008 20mcg	GW876008 20mcg
GW876008 200mcg	GW876008 200mcg	GW876008 200mcg

Primary Outcome Measures

Name	Time	Method
Signal reductions in the amygdala during viewing of emotional faces and during abdominal pain threat as measured by the fMRI.	throughout the study

Secondary Outcome Measures

Name	Time	Method
Questionnaires to assess IBS symptoms and anxiety	throughout the study

Trial Locations

Locations (1)

GSK Investigational Site; 🇺🇸 Los Angeles, California, United States