Conditions: Adenomatous Polyposis Coli
Keywords: FAP
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 106
Healthy volunteers: no

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

Detailed description:
Per DMC recommendation, the study was terminated early (31Oct2013) due to low enrollment and low endpoint accumulation rate. No safety concerns were involved in the decision to terminate the study.

Arms:
arm 1: celecoxib, 16 mg/kg/day, for 5 years arm 2: Masked, placebo comparator

Interventions: intervention 1: Celecoxib intervention 2: Placebo
Intervention descriptions: intervention 1: celecoxib, 16 mg/kg/day, for 5 years intervention 2: Masked, placebo comparator

Protocol document: