A Study In Patients With Irritable Bowel Syndrome To Measure Hormone Response After Dosing With GW876008 And Gsk561679

This study has been terminated.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00511563
First received: August 2, 2007
Last updated: January 18, 2008
Last verified: January 2008
  Purpose

To better understand the way that GW876008 and GSK561679 work on hormone responses in patients with Irritable Bowel Syndrome.


Condition Intervention Phase
Irritable Bowel Syndrome
Drug: GW876008 and GSK561679
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Double-Blind, Randomised, Placebo-Controlled, Three-Period Crossover Study to Investigate the Pharmacodynamic Effect of Two CRF-1 Antagonists GSK561679 and GW876008 on Meal Induced Cortisol Responses in Patients With IBS.

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Serum cortisol / ACTH and DHEA levels [ Time Frame: taken at 20 minute intervals over the study period. ]

Secondary Outcome Measures:
  • Serum cytokine levels [ Time Frame: taken at 20 minute intervals over the study period. ]

Enrollment: 0
Study Start Date: August 2007
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Has IBS as defined by the Rome II criteria.
  • Clinical laboratory tests at screening showing no clinically significant abnormalities in the opinion of the Principal Investigator.
  • Non-tobacco user (abstinence from tobacco use for at least 1 month before the start of the study).

Exclusion Criteria:

  • As a result of any of the medical interview, physical examination, evaluation of mental state and psychiatric history or screening investigations the physician responsible considers the subject unfit for the study.
  • Subject has any of the following exclusionary psychiatric conditions (Note: current diagnoses are to be based on the M.I.N.I administered at screening).
  • 1. A current DSM-IV Axis I disorder such as Dysthymia, Phobia, Major Depression, Obsessive Compulsive Disorder, Body Dysmorphic disorder, or Panic Disorder as a primary diagnosis currently or within 6 months prior to the screening visit.
  • 2. A current DSM-IV-TR diagnosis of Antisocial or Borderline Personality Disorder, Dementia, or another current DSM-IV-TR Axis II diagnosis that would suggest non-responsiveness to pharmacotherapy or non-compliance with the protocol; or
  • 3. A current (within six months prior to Screening Visit) diagnosis of anorexia nervosa or bulimia; or
  • 4. A history of Schizophrenia, Schizoaffective Disorder, or a Bipolar Disorder; or
  • 5. Is currently being treated by medication for any of the above psychiatric disorders. Psychiatric medications would include, but not limited to, antidepressants (e.g. SSRIs, SNRIs, TCAs) anxiolytics, antipsychotics
  • Subjects who, in the investigator's judgement, pose a current, serious or suicidal or homicidal risk or have made a suicide attempt within the past 6 months or have ever been homicidal.
  • subjects who have taken any medication for the treatment of IBS within 1 month prior to screening except for anti-diarrhoeal medications or laxatives for control of bowel habit which is allowed if at a stable dose for 2 weeks prior to randomisation.
  • Subjects who are taking NSAIDs including aspirin on a regular basis or within 48 hours of a study day.
  • Subjects with a history of PUD <10 years ago.
  • The subject has a history of, or active eating disorder.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00511563

Locations
Ireland
GSK Clinical Trials Call Center
Cork, Ireland
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GalxoSmithKline
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00511563     History of Changes
Other Study ID Numbers: CRI109244
Study First Received: August 2, 2007
Last Updated: January 18, 2008
Health Authority: Ireland: Irish Medicines Board

Keywords provided by GlaxoSmithKline:
Irritable Bowel Syndrome,
Cortisol,
stress,
response,
cytokine.

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on April 21, 2014