Effect of EPA-FFA on Polypectomy in Familial Adenomatous Polyposis

Status Active, not recruiting

Clinical Trial Summary

2 Year randomised, double-blind, placebo-controlled, parallel group study to determine the safety and efficacy of EPA-FFA gastro resistant capsules in FAP.

Clinical Trial Description

The purpose of this Phase III study is to determine whether Eicosapentaenoic acid-free fatty acid is a safe and well tolerated treatment in reducing the number of polypectomies FAP patients with an APC gene mutation have over a 2 year treatment period and to assess the effect that this has on clinical disease progression. Planned Sample Size This study will enrol 204 subjects (102 subjects per treatment group). Primary Objective is to determine the efficacy of EPA-FFA gastro-resistant capsules in patients with FAP in reducing polypectomy. Secondary objectives is to evaluate the clinical disease progression and the long-term safety and tolerability of EPA-FFA. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03806426
Study type	Interventional
Source	S.L.A. Pharma AG
Contact
Status	Active, not recruiting
Phase	Phase 3
Start date	December 5, 2018
Completion date	July 31, 2024

View Details

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