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Prevention of Colorectal Sporadic Adenomatous Polyps (PRESAP)

Basic Trial Information
Trial Description
Summary
Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase
Type
Status
Age
Sponsor
Protocol IDs

Phase III

Prevention

Completed

30 and over

Pharmaceutical / Industry

EQ4-00-02-018
A3191107, NCT00141193

Trial Description

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.

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.

Trial Contact Information

Trial Lead Organizations/Sponsors

Pfizer Incorporated

Pfizer CT.gov Call Center

Study Director

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00141193
Information obtained from ClinicalTrials.gov on August 06, 2008

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.