A Study In Patients With Irritable Bowel Syndrome To Measure Hormone Response After Dosing With GW876008 And Gsk561679

Irritable Bowel Syndrome Clinical Trial

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.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00511563
• Other study ID #: CRI109244
• Status: Withdrawn
• Phase: Phase 2
• First received: August 2, 2007
• Last updated: February 26, 2015
• Start date: August 2007

Study information

• Verified date: February 2015
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ireland: Irish Medicines Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Irritable Bowel Syndrome

Intervention

Drug:
• GW876008 and GSK561679
GW876008 and GSK561679

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum cortisol / ACTH and DHEA levels		taken at 20 minute intervals over the study period.
Secondary	Serum cytokine levels		taken at 20 minute intervals over the study period.