drugset / Trial / NCT00510692

Chemoprevention Trial in Familial Adenomatous Polyposis (FAP) Coli Using EPA

NCT00510692 ↗

Phase 2/3 Completed 58 enrolled S.L.A. Pharma AG
RandomizedParallel-groupQuadruple-blindPrevention

Summary

This purpose of this study is to investigate whether the number and size of rectal polyps can be reduced in patients with Familial Adenomatous Polyposis (FAP) by using a highly-purified form of a naturally occurring substance, the omega-3 fatty acid, eicosapentaenoic acid (EPA).

Timeline

Start
2006-11
Primary completion
2008-04
Completion
2008-04

Outcome

Met primary endpoint

registry 2g/Day Eicosapentaenoic Acid (EPA) vs Placebo; p = 0.005; Mean Difference (Net) -1.06 (95% CI -1.78 to -0.35); ANCOVA NCT00510692 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Eicosapentaenoic acid Small molecule 1000 mg —