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
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: 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
Syndrome
Colonic Diseases
Colonic Diseases, Functional
Digestive System Diseases
Disease
Gastrointestinal Diseases
Intestinal Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 21, 2014