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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00511563
Recruitment Status : Withdrawn (Cancelled before active due to the results of emerging scientific data)
First Posted : August 6, 2007
Last Update Posted : March 2, 2015
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Drug: GW876008 and GSK561679 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : August 2007
Actual Primary Completion Date : November 2012

Arm Intervention/treatment
Experimental: GW876008 and GSK561679
GW876008 and GSK561679
Drug: GW876008 and GSK561679
GW876008 and GSK561679

Primary Outcome Measures :
  1. Serum cortisol / ACTH and DHEA levels [ Time Frame: taken at 20 minute intervals over the study period. ]

Secondary Outcome Measures :
  1. Serum cytokine levels [ Time Frame: taken at 20 minute intervals over the study period. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   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).
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00511563

Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline

Responsible Party: GlaxoSmithKline Identifier: NCT00511563     History of Changes
Other Study ID Numbers: CRI109244
First Posted: August 6, 2007    Key Record Dates
Last Update Posted: March 2, 2015
Last Verified: February 2015

Keywords provided by GlaxoSmithKline:
Irritable Bowel Syndrome,

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases