NCT03806426

Effect of EPA-FFA on Polypectomy in Familial Adenomatous Polyposis

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)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 204 (estimated)
• Sponsor: S.L.A. Pharma AG · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Familial Adenomatous Polyposis

Interventions

Type	Name	Description
DRUG	Eicosapentaenoic acid free fatty acid (EPA-FFA)	500mg capsule, two 500mg capsules to be taken twice daily for 24 months
DRUG	Placebo	500mg capsule, two 500mg capsules to be taken twice daily for 24 months

Timeline

• Start date: 2018-12-05
• Primary completion: 2024-06-30
• Completion: 2024-07-31
• First posted: 2019-01-16
• Last updated: 2024-04-25

Locations

1 site across 1 country: Italy