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

May 15, 2017 updated by: GlaxoSmithKline

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Other: Placebo
placebo
Experimental: GW876008 20mcg
Drug: GW876008 20mcg
GW876008 20mcg
Experimental: GW876008 200mcg
Drug: GW876008 200mcg
GW876008

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
throughout the study

Secondary Outcome Measures

Outcome Measure
Time Frame
Questionnaires to assess IBS symptoms and anxiety
Time Frame: throughout the study
throughout the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Investigators

  • Study Director: GSK Clinical Trials, Dr, GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

September 13, 2006

First Submitted That Met QC Criteria

September 13, 2006

First Posted (Estimate)

September 15, 2006

Study Record Updates

Last Update Posted (Actual)

May 16, 2017

Last Update Submitted That Met QC Criteria

May 15, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRI103147

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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