A Phase III Placebo-Controlled Trial Of Celecoxib In Genotype Positive Subjects With Familial Adenomatous Polyposis

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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