Clinical Protocol For a Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Celecoxib (SC-58635) In The Prevention of Colorectal Sporadic Adenomatous Polyps (PRESAP)

Pfizer1 site in 1 country1,561 target enrollmentFebruary 2001

ConditionsColorectal Adenoma

InterventionsCelecoxib

DrugsCelecoxib

Overview

Phase: Phase 3
Intervention: Celecoxib
Conditions: Colorectal Adenoma
Sponsor: Pfizer
Enrollment: 1561
Locations: 1
Primary Endpoint: 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.
Status: Completed
Last Updated: 17 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 2001

End Date

May 2007

Last Updated

17 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Pfizer

Eligibility Criteria

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.

Arms & Interventions

A

Intervention: Celecoxib

Outcomes

Primary Outcomes

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 Outcomes

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)