Clinical trial NCT00511563: A Study In Patients With Irritable Bowel Syndrome To Measure Hormone Response After Dosing With GW876008 And Gsk561679
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.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Irritable Bowel Syndrome
Keywords: Cortisol,
stress,
response,
Irritable Bowel Syndrome,
cytokine.
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-08-06
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: Serum cortisol / ACTH and DHEA levels
timeFrame: taken at 20 minute intervals over the study period.
Secondary outcomes:
measure: Serum cytokine levels
timeFrame: taken at 20 minute intervals over the study period.
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: