A Study In Patients With Irritable Bowel Syndrome To Measure Hormone Response After Dosing With GW876008 And Gsk561679
Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on December 31, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Irritable Bowel Syndrome
Intervention: GW876008 and GSK561679 (Drug)
Phase: Phase 1/Phase 2
Status: Not yet recruiting
Sponsored by: GlaxoSmithKline
Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Director, Affiliation: GalxoSmithKline
To better understand the way that GW876008 and GSK561679 work on hormone responses in
patients with Irritable Bowel Syndrome.
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 design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Pharmacodynamics Study
Primary outcome: Serum cortisol / ACTH and DHEA levels
Secondary outcome: Serum cytokine levels
Minimum age: 18 Years.
Maximum age: 65 Years.
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
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
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
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
Subjects with a history of PUD <10 years ago.
The subject has a history of, or active eating disorder.
Locations and Contacts
GSK Clinical Trials Call Center, Cork, Ireland; Not yet recruiting
GSK Clinical Trials Call Center, Phone: 1-877-379-3718
Starting date: August 2007
Last updated: August 2, 2007