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Effect of EPA-FFA on Polypectomy in Familial Adenomatous Polyposis

NCT03806426 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 204

Last updated 2024-04-25

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • S.L.A. Pharma AG

    lead INDUSTRY

Principal Investigators

  • Luigi Ricciardiello, MD · Associate Professor of Gastroenterology, University of Bologna

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-05
Primary Completion
2024-06-30
Completion
2024-07-31

Countries

  • Italy

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03806426 on ClinicalTrials.gov