Randomized Placebo Controlled Efficacy And Safety Study Investigating GW876008 In Patients With Irritable Bowel Syndrome

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00421707
First received: January 10, 2007
Last updated: July 22, 2009
Last verified: July 2009
  Purpose

This is a double-blind, placebo-controlled, randomised crossover study to investigate the efficacy and safety of GW876008


Condition Intervention Phase
Irritable Bowel Syndrome (IBS)
Drug: GW876008
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomised, Double-blind, Placebo-controlled, Crossover Study to Evaluate Efficacy and Safety of the CRF1 Receptor Antagonist GW876008 in Patients With Irritable Bowel Syndrome

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Changes in wkly adequate relief [ Time Frame: wks 1-6, period 1 & wks 9-15, period 2 ]
  • Proportion of subjects with adequate relief of IBS pain & discomfort [ Time Frame: on all 4 of the last 4 wks of the treatment phase in period 1 & 2 ]
  • IBS GIS: [ Time Frame: weekly ]
  • IBSQoL: [ Time Frame: day 1,wks 6, 9, 15, 19 ]

Secondary Outcome Measures:
  • IBS composite symptom score: [ Time Frame: weekly ]
  • Changes in somatizer score (PHQ-15): [ Time Frame: day 1 and weeks 3, 6, 9, 12, 15 and 19 ]
  • Changes in anxiety and/or depression: [ Time Frame: day 1 and weeks 3, 6, 9, 12, 15 and 19. ]

Estimated Enrollment: 100
Study Start Date: November 2006
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: GW876008
    Other Name: GW876008
  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The subject has been diagnosed with IBS consistent with the Rome II Criteria as adapted in Appendix 3 of the protocol
  • The subject has normal results from a flexible sigmoidoscopy, colonoscopy, or a flexible sigmoidoscopy plus barium enema, according to subject's age, within 5 years of randomization. Otherwise, the appropriate procedure(s) must be performed and normal results obtained during the 7-day procedure window (prior to randomization):

If the subject is < 50 years of age and has not had a colonic examination within 5 years of the Screening Visit, flexible sigmoidoscopy, or colonoscopy must be performed.

If the subject is = 50 years of age and has not had a colonic examination within 5 years of the Screening Visit, a colonoscopy or flexible sigmoidoscopy plus barium enema must be performed.

  • Colonic procedure results must be known prior to randomization into the study and dispensing study medication
  • During the two-week screening phase, the subject must have conducted self assessments on = 10 days of 14 day (with 80% compliance on daily IVRS calls) compliance assessment using the telephone data entry system

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
  • Subject reported no stool for 7 consecutive days during the two-week screening phase responsible considers the subject unfit for the study
  • The subject has a concurrent illness or disability that may affect the interpretation of clinical data, or otherwise contraindicates participation in this clinical study (e.g., an unstable cardiovascular, autoimmune, renal, hepatic, pulmonary, endocrine, metabolic, gastrointestinal, haematological, or neurological condition).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00421707

Locations
United States, Arkansas
GSK Investigational Site
Sherwood, Arkansas, United States, 72120
United States, California
GSK Investigational Site
Concord, California, United States, 94520
GSK Investigational Site
Los Angeles, California, United States, 90095
United States, Florida
GSK Investigational Site
Tampa, Florida, United States, 33614
United States, Georgia
GSK Investigational Site
Stockbridge, Georgia, United States, 30281
United States, Massachusetts
GSK Investigational Site
Boston, Massachusetts, United States, 02215
United States, Missouri
GSK Investigational Site
St. Louis, Missouri, United States, 63110
United States, North Carolina
GSK Investigational Site
Greensboro, North Carolina, United States, 27408
United States, South Carolina
GSK Investigational Site
Greer, South Carolina, United States, 29651
United States, Tennessee
GSK Investigational Site
Germantown, Tennessee, United States, 38138
United States, Texas
GSK Investigational Site
Austin, Texas, United States, 78705
GSK Investigational Site
San Antonio, Texas, United States, 78209
United States, Virginia
GSK Investigational Site
Lynchburg, Virginia, United States, 24502
Canada, Nova Scotia
GSK Investigational Site
Truro, Nova Scotia, Canada, B2N 1L2
Canada, Ontario
GSK Investigational Site
Toronto, Ontario, Canada, M3N 2V7
GSK Investigational Site
Toronto, Ontario, Canada, M9W 4L6
GSK Investigational Site
Toronto, Ontario, Canada, M3H 5S4
GSK Investigational Site
Toronto, Ontario, Canada, M3J 1N2
Canada, Saskatchewan
GSK Investigational Site
Saskatoon, Saskatchewan, Canada, S7K 1J5
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, Dr GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00421707     History of Changes
Other Study ID Numbers: CRI105626
Study First Received: January 10, 2007
Last Updated: July 22, 2009
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by GlaxoSmithKline:
Irritable Bowel Syndrome safety

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

ClinicalTrials.gov processed this record on April 17, 2014