Status:
COMPLETED
Randomized Placebo Controlled Efficacy And Safety Study Investigating GW876008 In Patients With Irritable Bowel Syndrome
Lead Sponsor:
GlaxoSmithKline
Conditions:
Irritable Bowel Syndrome (IBS)
Eligibility:
All Genders
18-64 years
Phase:
PHASE2
Brief Summary
This is a double-blind, placebo-controlled, randomised crossover study to investigate the efficacy and safety of GW876008
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
October 14 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 25 2008
Estimated Enrollment :
133 Patients enrolled
Trial Details
Trial ID
NCT00421707
Start Date
October 14 2006
End Date
June 25 2008
Last Update
January 31 2018
Active Locations (23)
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1
GSK Investigational Site
Sherwood, Arkansas, United States, 72120
2
GSK Investigational Site
Concord, California, United States, 94520
3
GSK Investigational Site
Los Angeles, California, United States, 90095
4
GSK Investigational Site
Tampa, Florida, United States, 33614