Clinical Trial: Effect of EPA-FFA on Polypectomy in Familial Adenomatous Polyposis

Study Status: RECRUITING
Recruit Status: RECRUITING
Study Type: INTERVENTIONAL

Official Title: Randomised, Double-blind, Placebo-controlled Study of the Efficacy, Safety and Tolerability of EPA-FFA Gastro-resistant Capsules, in Patients With Familial Adenomatous Polyposis (FAP)

Brief 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.

Detailed Summary:

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.

Sponsor: S.L.A. Pharma AG

Current Primary Outcome: Proctectomy is indicated when polyp burden is frequently high in the remaining rectum, if large highly dysplastic polyps occur, or if frank malignancy develops.
Proctocolectomy also significantly reduces the cancer risk with the removal of the colon and rectum.

Original Primary Outcome: Proctectomy is indicated when polyp burden is frequently high in the remaining rectum, if large highly dysplastic polyps occur, or if frank malignancy develops.
Proctocolectomy also significantly reduces the cancer risk with the removal of the colon and rectum.

Current Secondary Outcome:

Original Secondary Outcome:

Information By: S.L.A. Pharma AG

Dates:
Date Received: January 09, 2019
Date Started: December 05, 2018
Date Completion: January 01, 2024
Last Updated: October 26, 2022
Last Verified: October 01, 2022