Prevention of Colorectal Sporadic Adenomatous Polyps (PRESAP)

Completed · Phase 3

Conditions studied: Colorectal Adenoma

In brief

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.

Key facts

Study ID

NCT00141193

Run by

Pfizer

People needed

1561

Starts

2001-02-01

Expected to finish

2007-05-01

Last updated by the study team

2008-08-06

Who can join

Age: 30 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• The subject has a history of Familial Adenomatous Polyposis or Hereditary Non-Polyposis Colorectal Cancer.
• The subject has a history of inflammatory bowel disease.

Where it is running

• 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
• Pfizer Investigational Site — Townsville, Queensland, Australia
• Pfizer Investigational Site — Geelong, Victoria, Australia
• Pfizer Investigational Site — Brussels, Belgium
• Pfizer Investigational Site — Brussels, Belgium
• Pfizer Investigational Site — Brussels, Belgium
• Pfizer Investigational Site — Ghent, Belgium
• Pfizer Investigational Site — Porto Alegre, Rio Grande do Sul, Brazil
• Pfizer Investigational Site — São Paulo, São Paulo, Brazil
• Pfizer Investigational Site — Edmonton, Alberta, Canada
• Pfizer Investigational Site — Abbotsford British Columbia, British Columbia, Canada
• Pfizer Investigational Site — Vancouver, British Columbia, Canada
• Pfizer Investigational Site — Vancouver, British Columbia, Canada
• Pfizer Investigational Site — Kingston, Ontario, Canada
• Pfizer Investigational Site — London, Ontario, Canada
• Pfizer Investigational Site — St. John's, Canada
• Pfizer Investigational Site — San Diego, California, United States

Full record on ClinicalTrials.gov

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