Prevention of Colorectal Sporadic Adenomatous Polyps (PRESAP)
Status and phase
Completed
Phase 3
Conditions
Colorectal Adenoma
Treatments
Drug: Celecoxib
Details and patient eligibility
About
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.
Enrollment
1,561 patients
Sex
All
Ages
30+ years old
Volunteers
No Healthy Volunteers
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.
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Double Blind
1,561 participants in 1 patient group, including a placebo group
A
Placebo Comparator group
Treatment:
Drug: Celecoxib
Trial contacts and locations
106
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Data sourced from clinicaltrials.gov
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