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

This study has been completed.
Information provided by (Responsible Party):
ClinicalTrials.gov Identifier:
First received: January 10, 2007
Last updated: September 17, 2015
Last verified: September 2015
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
Other: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • IBS GIS: [ Time Frame: weekly ] [ Designated as safety issue: No ]
  • IBSQoL: [ Time Frame: day 1,wks 6, 9, 15, 19 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • IBS composite symptom score: [ Time Frame: weekly ] [ Designated as safety issue: No ]
  • Changes in somatizer score (PHQ-15): [ Time Frame: day 1 and weeks 3, 6, 9, 12, 15 and 19 ] [ Designated as safety issue: No ]
  • Changes in anxiety and/or depression: [ Time Frame: day 1 and weeks 3, 6, 9, 12, 15 and 19. ] [ Designated as safety issue: No ]

Enrollment: 133
Study Start Date: November 2006
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GW876008
Drug: GW876008
Placebo Comparator: Placebo
Drug: GW876008 Other: Placebo


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00421707

  Show 23 Study Locations
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00421707     History of Changes
Other Study ID Numbers: CRI105626
Study First Received: January 10, 2007
Last Updated: September 17, 2015
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
Colonic Diseases, Functional
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 27, 2015