Last updated: 11/04/2018 06:04:46

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

GSK study ID
CRI109244
Clinicaltrials.gov ID
NCT00511563
EudraCT ID
2007-000929-22
EU CT Number
Not applicable
Trial status
Other
Other
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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.
Trial description: To better understand the way that GW876008 and GSK561679 work on hormone responses in patients with Irritable Bowel Syndrome.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

Serum cortisol / ACTH and DHEA levels

Timeframe: taken at 20 minute intervals over the study period.

Secondary outcomes:

Serum cytokine levels

Timeframe: taken at 20 minute intervals over the study period.

Interventions:
  • Drug: GW876008 and GSK561679
    • Enrollment:
    0
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Irritable Bowel Syndrome
    Product
    emicerfont
    Collaborators
    Not applicable
    Study date(s)
    November 2007 to March 2008
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 65 years
    Accepts healthy volunteers
    No
    • 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.
    • 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).
    Inclusion and exclusion 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.

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    No study documents available.

    Results overview

    Study Results yet to be posted

    Recruitment status
    Other
    Actual primary completion date
    Not applicable
    Actual study completion date
    Not applicable

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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