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

NCT00511563 | Withdrawn Phase 2

• 1 other identifier: CRI109244
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Keywords

Cortisol,; stress,; response,; Irritable Bowel Syndrome,; cytokine.

Outcome Measures

Primary Outcomes (1)

• Serum cortisol / ACTH and DHEA levels

  taken at 20 minute intervals over the study period.

Secondary Outcomes (1)

• Serum cytokine levels

  taken at 20 minute intervals over the study period.

Study Arms (1)

GW876008 and GSK561679

EXPERIMENTAL

GW876008 and GSK561679

Drug: GW876008 and GSK561679

Interventions

GW876008 and GSK561679 DRUG

GW876008 and GSK561679

GW876008 and GSK561679

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.
• \. 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.
• \. 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
• \. A current (within six months prior to Screening Visit) diagnosis of anorexia nervosa or bulimia; or
• \. A history of Schizophrenia, Schizoaffective Disorder, or a Bipolar Disorder; or
• \. 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

GW 876008; NBI 77860

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2007
• First Posted: August 6, 2007
• Study Start: August 1, 2007
• Primary Completion: November 1, 2012
• Last Updated: March 2, 2015

Record last verified: 2015-02