ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
A Study In Patients With Irritable Bowel Syndrome To Measure Hormone Response After Dosing With GW876008 And Gsk561679

This study has been terminated.

Sponsored by: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00511563
  Purpose

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


Condition Intervention Phase
Irritable Bowel Syndrome
Drug: GW876008 and GSK561679
Phase I
Phase II

ChemIDplus related topics:   Hydrocortisone    Cortisol 21-phosphate    Cortisol succinate    Hydrocortamate    Hydrocortisone 21-sodium succinate    Hydrocortisone acetate    Hydrocortisone cypionate    Hydrocortisone hemisuccinate    Proctofoam-HC   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Pharmacodynamics Study
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.

Further study details as provided by GlaxoSmithKline:

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. ]

Enrollment:   0
Study Start Date:   August 2007

  Eligibility
Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00511563

Locations
Ireland
GSK Clinical Trials Call Center    
      Cork, Ireland

Sponsors and Collaborators
GlaxoSmithKline

Investigators
Study Director:     GSK Clinical Trials, MD     GalxoSmithKline    
  More Information


Study ID Numbers:   CRI109244
First Received:   August 2, 2007
Last Updated:   January 18, 2008
ClinicalTrials.gov Identifier:   NCT00511563
Health Authority:   Ireland: Irish Medicines Board

Keywords provided by GlaxoSmithKline:
Irritable Bowel Syndrome,  
Cortisol,  
stress,  
response,  
cytokine.  

Study placed in the following topic categories:
Hydrocortisone
Digestive System Diseases
Cortisol succinate
Gastrointestinal Diseases
Colonic Diseases
Irritable Bowel Syndrome
Stress
Hydrocortisone acetate
Intestinal Diseases
Colonic Diseases, Functional

Additional relevant MeSH terms:
Pathologic Processes
Disease
Syndrome

ClinicalTrials.gov processed this record on October 17, 2008




Links to all studies - primarily for crawlers