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Trial In Pediatric Patients With Familial Adenomatous Polyposis (FAP)

Last updated on March 14, 2019

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Study Location
Pfizer Investigational Site
Chicago, Illinois, 60612 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Adenomatous Polyposis Coli
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
10-17 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
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- 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

NCT00585312
Pfizer
Terminated
Trial In Pediatric Patients With Familial Adenomatous Polyposis (FAP)

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