A Study In Patients With Irritable Bowel Syndrome To Measure Hormone Response After Dosing With GW876008 And Gsk561679
This study has been terminated.
Information provided by:
First received: August 2, 2007
Last updated: January 18, 2008
Last verified: January 2008
To better understand the way that GW876008 and GSK561679 work on hormone responses in patients with Irritable Bowel Syndrome.
Irritable Bowel Syndrome
Drug: GW876008 and GSK561679
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Primary Purpose: Treatment
||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.
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. ]
| Study Start Date:
|Ages Eligible for Study:
||18 Years to 65 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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).
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00511563
|GSK Clinical Trials Call Center
|Cork, Ireland |
||GSK Clinical Trials, MD
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||August 2, 2007
||January 18, 2008
||Ireland: Irish Medicines Board
Keywords provided by GlaxoSmithKline:
Irritable Bowel Syndrome,
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 03, 2013
Irritable Bowel Syndrome
Colonic Diseases, Functional
Digestive System Diseases