Prevention of Colorectal Sporadic Adenomatous Polyps (PRESAP)

Pfizer1,561 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

1,561

Conditions

Colorectal Adenoma

Interventions

CelecoxibDRUG

Eligibility

Sex: ALLMin age: 30 Years

Medical Language ↔ Plain English

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.

Locations (106)

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

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

Data from ClinicalTrials.gov

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Pfizer Investigational Site

San Diego, California, United States

Pfizer Investigational Site

San Kiego, California, United States

Pfizer Investigational Site

North Chicago, Illinois, United States

Pfizer Investigational Site

Oak Park, Illinois, United States

Pfizer Investigational Site

Baltimore, Maryland, United States

Pfizer Investigational Site

Baltimore, Maryland, United States

Pfizer Investigational Site

Philadelphia, Pennsylvania, United States

Pfizer Investigational Site

Philadelphia, Pennsylvania, United States

Pfizer Investigational Site

Houston, Texas, United States

Pfizer Investigational Site

Richmond, Virginia, United States

...and 96 more locations