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

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ClinicalTrials.gov Identifier: NCT00376896
Recruitment Status : Completed
First Posted : September 15, 2006
Last Update Posted : May 16, 2017
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Irritable Colon Irritable Bowel Syndrome (IBS) Drug: GW876008 200mcg Drug: GW876008 20mcg Other: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : November 2006
Primary Completion Date : October 2008
Study Completion Date : October 2008

Arm Intervention/treatment
Experimental: GW876008 20mcg
GW876008 20mcg
Drug: GW876008 20mcg
GW876008 20mcg
Experimental: GW876008 200mcg
GW876008 200mcg
Drug: GW876008 200mcg
Placebo Comparator: Placebo
Other: Placebo

Primary Outcome Measures :
  1. 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 Measures :
  1. Questionnaires to assess IBS symptoms and anxiety [ Time Frame: throughout the study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00376896

United States, California
GSK Investigational Site
Los Angeles, California, United States, 90095
Sponsors and Collaborators
Study Director: GSK Clinical Trials, Dr GlaxoSmithKline

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00376896     History of Changes
Other Study ID Numbers: CRI103147
First Posted: September 15, 2006    Key Record Dates
Last Update Posted: May 16, 2017
Last Verified: May 2017

Keywords provided by GlaxoSmithKline:

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Corticotropin-Releasing Hormone
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs