Prevention of Colorectal Sporadic Adenomatous Polyps (PRESAP) (PRESAP)
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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.
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. [ Time Frame: 3 years ]
Secondary Outcome Measures :
The number of colorectal adenomas in study subjects [ Time Frame: 3 years ]
the histopathologic grade of colorectal adenomas [ Time Frame: 3 years ]
the size of colorectal adenomas measured after one year and three years of study drug use. [ Time Frame: 3 years ]
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Layout table for eligibility information
Ages Eligible for Study:
30 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
The subject has a history of Familial Adenomatous Polyposis or Hereditary Non-Polyposis Colorectal Cancer.
The subject has a history of inflammatory bowel disease.