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:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00376896
First received: September 13, 2006
Last updated: April 6, 2011
Last verified: April 2011
  Purpose

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 Intervention Phase
Irritable Colon
Irritable Bowel Syndrome (IBS)
Drug: GW876008 200mcg
Drug: GW876008 20mcg
Other: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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)

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Questionnaires to assess IBS symptoms and anxiety [ Time Frame: throughout the study ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: November 2006
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GW876008 20mcg
GW876008 20mcg
Drug: GW876008 20mcg
GW876008 20mcg
Experimental: GW876008 200mcg
GW876008 200mcg
Drug: GW876008 200mcg
GW876008
Placebo Comparator: Placebo
Placebo
Other: Placebo
placebo

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00376896

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

No publications provided

Responsible Party: Cheri Hudson;Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00376896     History of Changes
Other Study ID Numbers: CRI103147
Study First Received: September 13, 2006
Last Updated: April 6, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
IBS fMRI

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

ClinicalTrials.gov processed this record on July 20, 2014