Randomized Placebo Controlled Efficacy And Safety Study Investigating GW876008 In Patients With Irritable Bowel Syndrome
NCT ID: NCT00421707
Last Updated: 2018-01-31
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
133 participants
INTERVENTIONAL
2006-10-14
2008-06-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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GW876008
GW876008
GW876008
Placebo
Placebo
GW876008
Placebo
Interventions
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GW876008
Placebo
Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
18 Years
64 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Sherwood, Arkansas, United States
GSK Investigational Site
Concord, California, United States
GSK Investigational Site
Los Angeles, California, United States
GSK Investigational Site
Tampa, Florida, United States
GSK Investigational Site
Stockbridge, Georgia, United States
GSK Investigational Site
Louisville, Kentucky, United States
GSK Investigational Site
Monroe, Louisiana, United States
GSK Investigational Site
Boston, Massachusetts, United States
GSK Investigational Site
St Louis, Missouri, United States
GSK Investigational Site
Greensboro, North Carolina, United States
GSK Investigational Site
Anderson, South Carolina, United States
GSK Investigational Site
Greer, South Carolina, United States
GSK Investigational Site
Chattanooga, Tennessee, United States
GSK Investigational Site
Germantown, Tennessee, United States
GSK Investigational Site
Austin, Texas, United States
GSK Investigational Site
San Antonio, Texas, United States
GSK Investigational Site
Lynchburg, Virginia, United States
GSK Investigational Site
Truro, Nova Scotia, Canada
GSK Investigational Site
Toronto, Ontario, Canada
GSK Investigational Site
Toronto, Ontario, Canada
GSK Investigational Site
Toronto, Ontario, Canada
GSK Investigational Site
Toronto, Ontario, Canada
GSK Investigational Site
Saskatoon, Saskatchewan, Canada
Countries
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Other Identifiers
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CRI105626
Identifier Type: -
Identifier Source: org_study_id
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