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

NCT ID: NCT00511563

Last Updated: 2015-03-02

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-08-31

Brief Summary

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

Conditions

Irritable Bowel Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

GW876008 and GSK561679

GW876008 and GSK561679

Group Type: EXPERIMENTAL

GW876008 and GSK561679

Intervention Type: DRUG

GW876008 and GSK561679

Interventions

GW876008 and GSK561679

GW876008 and GSK561679

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Other Identifiers

CRI109244

Identifier Type: -

Identifier Source: org_study_id