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

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)

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00376896

Enrollment

Registered

2006-09-15

Start date

2006-11-30

Completion date

2008-10-31

Last updated

2017-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irritable Bowel Syndrome (IBS), Irritable Colon

Keywords

IBS fMRI

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.

Interventions

DRUGGW876008 200mcg

GW876008

DRUGGW876008 20mcg

GW876008 20mcg

OTHERPlacebo

placebo

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 65 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
Questionnaires to assess IBS symptoms and anxiety	throughout the study

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026