Trial In Pediatric Patients With Familial Adenomatous Polyposis (FAP)

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Adenomatous Polyposis Coli

In brief

To test whether celecoxib can be used to prevent colon polyp formation in children with familial adenomatous polyposis (FAP).

Key facts

Study ID

NCT00585312

Run by

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

People needed

106

Starts

2006-09-01

Expected to finish

2013-10-01

Last updated by the study team

2021-02-21

Who can join

Age: 10 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 10-17 years
• Confirmed deleterious FAP genotype based on central genetic testing or personal history ot >2 colorectal adenomas and a parent with the diagnosis of FAP and either A, B or C below A: Non-attenuated FAP genotype B: Attenuated FAP genotype and a personal history of colorectal adenomas and a first degree relative with FAP C: No genotype identified with a personal history of > 2 adenomas and have a parent with FAP
• Less than 30 polyps, which need to be removed to render the colon polyp-free before study drug can be given

You may not qualify if…

• Diagnosis of attenuated FAP based on central genetic testing in the absence of a personal history of >2 colorectal adenomas and a first degree relative (parent or sibling) with FAP.
• Sensitivity to COX-2 inhibitors

Where it is running

• Pfizer Investigational Site — Chicago, Illinois, United States
• Pfizer Investigational Site — Ann Arbor, Michigan, United States
• Pfizer Investigational Site — Omaha, Nebraska, United States
• Pfizer Investigational Site — New York, New York, United States
• Pfizer Investigational Site — New York, New York, United States
• Pfizer Investigational Site — New York, New York, United States
• Pfizer Investigational Site — Chagrin Falls, Ohio, United States
• Pfizer Investigational Site — Cincinnati, Ohio, United States
• Pfizer Investigational Site — Cleveland, Ohio, United States
• Pfizer Investigational Site — Cleveland, Ohio, United States
• Pfizer Investigational Site — Elyria, Ohio, United States
• Pfizer Investigational Site — Independence, Ohio, United States
• Pfizer Investigational Site — Lakewood, Ohio, United States
• Pfizer Investigational Site — Lorain, Ohio, United States
• Pfizer Investigational Site — Solon, Ohio, United States
• Pfizer Investigational Site — Strongsville, Ohio, United States
• Pfizer Investigational Site — Westlake, Ohio, United States
• Pfizer Investigational Site — Willoughby Hills, Ohio, United States
• Pfizer Investigational Site — Wooster, Ohio, United States
• Pfizer Investigational Site — Nashville, Tennessee, United States
• Pfizer Investigational Site — Houston, Texas, United States
• Pfizer Investigational Site — Salt Lake City, Utah, United States
• Pfizer Investigational Site — Salt Lake City, Utah, United States
• Pfizer Investigational Site — Brussels, Belgium
• Pfizer Investigational Site — Ghent, Belgium

Full record on ClinicalTrials.gov

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