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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2008-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Irritable Colon Irritable Bowel Syndrome (IBS)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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GW876008 20mcg

Group Type EXPERIMENTAL

GW876008 20mcg

Intervention Type DRUG

GW876008 20mcg

GW876008 200mcg

Group Type EXPERIMENTAL

GW876008 200mcg

Intervention Type DRUG

GW876008

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

placebo

Interventions

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GW876008 200mcg

GW876008

Intervention Type DRUG

GW876008 20mcg

Intervention Type DRUG

Placebo

placebo

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes