| Inclusion Criteria: | 1) Confirmed diagnosis of non-attenuated FAP based on central genetic testing
2) Male or female subjects aged 10 to 17 years inclusive at the time of enrollment
3) Subject's parent or legal guardian has provided written informed consent prior to enrollment in this study
4) Subject has assented to participate prior to enrollment in this study
5) Subject and parent/legal guardian, agree to comply with study requirements and are able to be at the clinic for all required study visits
6) Willingness to abstain from the chronic use of NSAIDs (including aspirin, selective COX-2 inhibitors), oral adrenocorticosteroids, and other nonsteroidal OTC products for the duration of the study. Chronic use of NSAIDs is defined as a frequency of 1 week (7 consecutive days) for more than 3 weeks per year
7) If subject is female and of childbearing potential, she must meet all of the following conditions: · Have been using adequate contraception (e.g. abstinence, condom, IUD, birth control pill, diaphragm and spermicide foam/gel/cream/suppository combination) since her last menses AND · Be willing to use adequate contraception (as above) during the study AND · Not be breastfeeding AND · (continue # 8)
8) (Continue # 7) Have a negative urine or serum pregnancy test within 14 days prior to study drug administration. If the central serum pregnancy test results are >14 days prior to study drug administration the test must be repeated. This will be done locally by either serum or urine testing.
9) If subject is male and sexually active he must be willing to use a condom and be instructed that his female partner should be using adequate contraception (e.g. female condom, IUD, sub dermal implant, birth control pill, diaphragm and spermicidal foam/gel/cream/suppository combination)
10) The subject will be allowed to proceed to baseline colonoscopy so long as all of the following laboratory criteria (limits of normal for age as appropriate) are met on Baseline evaluation: · Hemoglobin > 10.0 gm/dl · Platelet count > 100,000/microliter · WBC > 3,000/microliter · ALT < 1.5 x UNL; AST < 1.5 x UNL; Alkaline Phosphatase < 1.5 x UNL; Total Bilirubin < 1.5 x UNL unless the subject has Gilbert's disease for which Total Bilirubin must be less or equal than 2.0xULN (Continue #11)·
11) (Continue #10) • Calculated Creatinine Clearance > 90 mL/min/1.73 • No evidence of proteinuria or hematuria • Cholesterol < 1.5x upper limit of normal • Microalbuminuria </= 23 mg/L • For tests not mentioned specifically, there must be no clinically significan abnormalities that in the opinion of the PI would preclude a subject's safe participation
12) Intact colon
13) Colonoscopy will be performed at baseline according to the description provided in Section 8 Colonoscopy Procedures. To proceed to randomization, the subject must have all of the following: · An assessable colon endoscopically evaluated following an adequate bowel preparation AND · If < 20 polyps (> 2mm in size), all must be removed so as to render the colon polyp-free and thus amenable to serial endoscopic surveillance
14) Systolic and Diastolic Blood Pressure < 95th percentile. All Blood Pressure measurements will be taken according to the description provided in Section 7.4. (Blood Pressure Evaluation). Those subjects with blood pressure measurements within the >/= 90 to < 95th percentile group are eligible for enrollment. These subjects must be managed according to the description in Section 8.14 (Blood Pressure Management) |