Status:
COMPLETED
Prevention of Colorectal Sporadic Adenomatous Polyps (PRESAP)
Lead Sponsor:
Pfizer
Conditions:
Colorectal Adenoma
Eligibility:
All Genders
30+ years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
- The subject has a history of Familial Adenomatous Polyposis or Hereditary Non-Polyposis Colorectal Cancer.
- The subject has a history of inflammatory bowel disease.
Key Trial Info
Start Date :
February 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2007
Estimated Enrollment :
1561 Patients enrolled
Trial Details
Trial ID
NCT00141193
Start Date
February 1 2001
End Date
May 1 2007
Last Update
August 6 2008
Active Locations (106)
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1
Pfizer Investigational Site
San Diego, California, United States, 92123
2
Pfizer Investigational Site
San Kiego, California, United States, 92123
3
Pfizer Investigational Site
North Chicago, Illinois, United States, 60064
4
Pfizer Investigational Site
Oak Park, Illinois, United States, 60304