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

Tracking Information
First Submitted Date ICMJE	September 13, 2006
First Posted Date ICMJE	September 15, 2006
Last Update Posted Date	May 16, 2017
Study Start Date ICMJE	November 2006
Actual Primary Completion Date	October 2008 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: August 16, 2007)	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 ]
Original Primary Outcome Measures ICMJE; (submitted: September 13, 2006)	Signal reductions in the amygdala during viewing of emotional faces and during abdominal pain threat as measured by the fMRI.
Change History	Complete list of historical versions of study NCT00376896 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: August 16, 2007)	Questionnaires to assess IBS symptoms and anxiety [ Time Frame: throughout the study ]
Original Secondary Outcome Measures ICMJE; (submitted: September 13, 2006)	Questionnaires to assess IBS symptoms and anxiety
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Study On The Effect Of GW876008 On Cerebral Blood Flow In Irritable Bowel Syndrome (IBS) Patients And Healthy Volunteers
Official Title ICMJE	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)
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.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Phase 1
Study Design ICMJE	Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition ICMJE	Irritable Colon; Irritable Bowel Syndrome (IBS)
Intervention ICMJE	Drug: GW876008 200mcg GW876008; Drug: GW876008 20mcg GW876008 20mcg; Other: Placebo placebo
Study Arms	Experimental: GW876008 20mcg GW876008 20mcg Intervention: Drug: GW876008 20mcg; Experimental: GW876008 200mcg GW876008 200mcg Intervention: Drug: GW876008 200mcg; Placebo Comparator: Placebo Placebo Intervention: Other: Placebo
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: May 15, 2017)	25
Original Enrollment ICMJE; (submitted: September 13, 2006)	40
Actual Study Completion Date	October 2008
Actual Primary Completion Date	October 2008 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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.
Sex/Gender	Sexes Eligible for Study: Female
Ages	18 Years to 65 Years (Adult)
Accepts Healthy Volunteers	Yes
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00376896
Other Study ID Numbers ICMJE	CRI103147
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	GlaxoSmithKline
Study Sponsor ICMJE	GlaxoSmithKline
Collaborators ICMJE	Not Provided
Investigators ICMJE	Study Director: GSK Clinical Trials, Dr GlaxoSmithKline
PRS Account	GlaxoSmithKline
Verification Date	May 2017
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP