Back to resultsStudy On The Effect Of GW876008 On Cerebral Blood Flow In Irritable Bowel Syndrome (IBS) Patients And Healthy Volunteers
Primary Purpose
Irritable Colon, Irritable Bowel Syndrome (IBS)
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
GW876008 200mcg
GW876008 20mcg
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Irritable Colon focused on measuring IBS fMRI
Eligibility Criteria
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.
Sites / Locations
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
GW876008 20mcg
GW876008 200mcg
Placebo
Arm Description
GW876008 20mcg
GW876008 200mcg
Placebo
Outcomes
Primary Outcome Measures
Signal reductions in the amygdala during viewing of emotional faces and during abdominal pain threat as measured by the fMRI.
Secondary Outcome Measures
Questionnaires to assess IBS symptoms and anxiety
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00376896
Brief Title
Study On The Effect Of GW876008 On Cerebral Blood Flow In Irritable Bowel Syndrome (IBS) Patients And Healthy Volunteers
Official Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Colon, Irritable Bowel Syndrome (IBS)
Keywords
IBS fMRI
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GW876008 20mcg
Arm Type
Experimental
Arm Description
GW876008 20mcg
Arm Title
GW876008 200mcg
Arm Type
Experimental
Arm Description
GW876008 200mcg
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
GW876008 200mcg
Intervention Description
GW876008
Intervention Type
Drug
Intervention Name(s)
GW876008 20mcg
Intervention Description
GW876008 20mcg
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
Signal reductions in the amygdala during viewing of emotional faces and during abdominal pain threat as measured by the fMRI.
Time Frame
throughout the study
Secondary Outcome Measure Information:
Title
Questionnaires to assess IBS symptoms and anxiety
Time Frame
throughout the study
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials, Dr
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study On The Effect Of GW876008 On Cerebral Blood Flow In Irritable Bowel Syndrome (IBS) Patients And Healthy Volunteers
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