Last updated: 11/04/2018 06:04:30
Study On The Effect Of GW876008 On Cerebral Blood Flow In Irritable Bowel Syndrome (IBS) Patients And Healthy Volunteers
GSK study ID
CRI103147
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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)
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Signal reductions in the amygdala during viewing of emotional faces and during abdominal pain threat as measured by the fMRI.
Timeframe: throughout the study
Secondary outcomes:
Questionnaires to assess IBS symptoms and anxiety
Timeframe: throughout the study
Interventions:
Drug: GW876008 200mcg
Drug: GW876008 20mcg
Other: Placebo
Enrollment:
25
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Irritable Colon
Product
emicerfont
Collaborators
Not applicable
Study date(s)
November 2006 to October 2008
Type
Interventional
Phase
1
Participation criteria
Sex
Female
Age
18 - 65 years
Accepts healthy volunteers
Yes
- 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.
- 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
Inclusion and exclusion 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.
Trial location(s)
Location
GSK Investigational Site
Los Angeles, California, United States, 90095
Status
Study Complete
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2008-13-10
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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