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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00376896
First received: September 13, 2006
Last updated: May 15, 2017
Last verified: May 2017

September 13, 2006
May 15, 2017
November 2006
October 2008   (Final data collection date for primary outcome measure)
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 ]
Signal reductions in the amygdala during viewing of emotional faces and during abdominal pain threat as measured by the fMRI.
Complete list of historical versions of study NCT00376896 on ClinicalTrials.gov Archive Site
Questionnaires to assess IBS symptoms and anxiety [ Time Frame: throughout the study ]
Questionnaires to assess IBS symptoms and anxiety
Not Provided
Not Provided
 
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)
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
  • Irritable Colon
  • Irritable Bowel Syndrome (IBS)
  • Drug: GW876008 200mcg
    GW876008
  • Drug: GW876008 20mcg
    GW876008 20mcg
  • Other: Placebo
    placebo
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
October 2008
October 2008   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
18 Years to 65 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00376896
CRI103147
Not Provided
Not Provided
Not Provided
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials, Dr GlaxoSmithKline
GlaxoSmithKline
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP