A Study In Patients With Irritable Bowel Syndrome To Measure Hormone Response After Dosing With G… (NCT00511563) | Clinical Trial Compass
WithdrawnPhase 2
A Study In Patients With Irritable Bowel Syndrome To Measure Hormone Response After Dosing With GW876008 And Gsk561679
Stopped: Cancelled before active due to the results of emerging scientific data
0Started 2007-08
Plain-language summary
To better understand the way that GW876008 and GSK561679 work on hormone responses in patients with Irritable Bowel Syndrome.
Who can participate
Age range18 Years – 65 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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, …
What they're measuring
1
Serum cortisol / ACTH and DHEA levels
Timeframe: taken at 20 minute intervals over the study period.