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Completed

NCT Number: NCT00376896

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

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.

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Key information

Conditions

Irritable Colon Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Irritable Bowel Syndrome Irritable Bowel Syndrome (IBS)

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site

Los Angeles, California, 90095, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GW876008 200mcg

Drug

GW876008

GW876008 20mcg

Drug

GW876008 20mcg

Placebo

Other

placebo

Primary outcomes

  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 outcomes

  1. Questionnaires to assess IBS symptoms and anxiety

    Time frame: throughout the study

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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)

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Sep 15, 2006
Registry last updated
May 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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