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)
1 other identifier
interventional
25
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Nov 2006
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 13, 2006
CompletedFirst Posted
Study publicly available on registry
September 15, 2006
CompletedStudy Start
First participant enrolled
November 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2008
CompletedMay 16, 2017
May 1, 2017
1.9 years
September 13, 2006
May 15, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Signal reductions in the amygdala during viewing of emotional faces and during abdominal pain threat as measured by the fMRI.
throughout the study
Secondary Outcomes (1)
Questionnaires to assess IBS symptoms and anxiety
throughout the study
Study Arms (3)
GW876008 20mcg
EXPERIMENTALGW876008 20mcg
GW876008 200mcg
EXPERIMENTALGW876008 200mcg
Placebo
PLACEBO COMPARATORPlacebo
Interventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (1)
GSK Investigational Site
Los Angeles, California, 90095, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials, Dr
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2006
First Posted
September 15, 2006
Study Start
November 1, 2006
Primary Completion
October 1, 2008
Study Completion
October 1, 2008
Last Updated
May 16, 2017
Record last verified: 2017-05