Prevention of Colorectal Sporadic Adenomatous Polyps (PRESAP)
- Registration Number
- NCT00141193
- Lead Sponsor
- Pfizer
- Brief Summary
This study is a prospective, randomized, double-blind, placebo-controlled, multi-center trial to compare the efficacy and safety of celecoxib 400mg QD versus placebo in reducing the occurrence of new colorectal adenomas post-polypectomy at Month 13 (Year 1) and Month 37 (Year 3) of study drug administration.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1561
Inclusion Criteria
- The subject has had a documented colonoscopy to the cecum performed by a study-related physician with adequate preparation resulting in diagnosis and clearance of an adenomatous polyp(s) within 4 months prior to randomization.
- The subject is willing to abstain from chronic use of all NSAIDs or COX-2 inhibitors excluding aspirin at cardioprotective doses for the duration of the study.
Exclusion Criteria
- The subject has a history of Familial Adenomatous Polyposis or Hereditary Non-Polyposis Colorectal Cancer.
- The subject has a history of inflammatory bowel disease.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A Celecoxib -
- Primary Outcome Measures
Name Time Method To evaluate the effects of celecoxib in reducing the proportion of subjects with new colorectal adenomas post baseline polypectomy after Month 13 (Year 1) and Month 37 (Year 3) of study drug administration. 3 years
- Secondary Outcome Measures
Name Time Method The number of colorectal adenomas in study subjects 3 years the histopathologic grade of colorectal adenomas 3 years the size of colorectal adenomas measured after one year and three years of study drug use. 3 years
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇺🇾Montevideo, Uruguay