Trial In Pediatric Patients With Familial Adenomatous Polyposis (FAP)

• Drug: Celecoxib
  
  celecoxib, 16 mg/kg/day, for 5 years
  Other Name: celebrex, SC-58635
• Drug: Placebo
  
  Masked, placebo comparator

• Experimental: Celecoxib
  
  celecoxib, 16 mg/kg/day, for 5 years
  Intervention: Drug: Celecoxib
• Placebo Comparator: Placebo
  
  Masked, placebo comparator
  Intervention: Drug: Placebo

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