NCT00511563WithdrawnPhase 2
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.
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Withdrawn
- Sponsor
- GlaxoSmithKline
- Primary Endpoint
- Serum cortisol / ACTH and DHEA levels
Study Overview
Brief Summary
To better understand the way that GW876008 and GSK561679 work on hormone responses in patients with Irritable Bowel Syndrome.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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).
- •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.
- •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
- •A current (within six months prior to Screening Visit) diagnosis of anorexia nervosa or bulimia; or
- •A history of Schizophrenia, Schizoaffective Disorder, or a Bipolar Disorder; or
- •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.
Arms & Interventions
GW876008 and GSK561679
Experimental
GW876008 and GSK561679
Intervention: GW876008 and GSK561679 (Drug)
Outcomes
Primary Outcomes
Serum cortisol / ACTH and DHEA levels
Time Frame: taken at 20 minute intervals over the study period.
Secondary Outcomes
- Serum cytokine levels(taken at 20 minute intervals over the study period.)
Investigators
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