UnknownPhase 3

Effect of EPA-FFA on Polypectomy in Familial Adenomatous Polyposis

Italy204 participantsStarted 2018-12-05

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Must give written informed consent.
✓. Male or female subjects, 18 to 65 years of age.
✓. Known diagnosis of FAP defined as those with a pathogenic APC mutation
✓. Patients have had a previous colectomy with an ileo-rectal anastomosis or an ileal pouch- anal anastomosis with a rectal remnant of ≥ 2cm.
✓. Classified stage 1-3 on InSiGHT Polyposis Staging System (IPSS).
✓. Subjects must show a willingness to abstain from regular use of non-steroidal anti-inflammatory medication for the trial. A cardio protective dose of aspirin (75mg-100mg) will be permitted.

Exclusion criteria

✕. Subjects with ileo-rectal anastomosis who have ≥ 20 polyps which are of \>5mm that are not amendable to removal in the rectum.
✕. Subjects unwilling to have regular sigmoidoscopy examination.
✕. Subjects who are due to undergo gastro-intestinal surgery related to FAP.
✕. History of invasive carcinoma in the past 3 years.
✕. History of pelvic radiation.
✕. Known allergic reaction or intolerant to fish or fish oils.
✕. Known allergic reaction to excipients of IMP and placebo.
✕. Subjects who are pregnant or breast-feeding at screening.

What they're measuring

Total Number of Polypectomies (polyps > 5mm in the rectum) conducted during the 24 months study period

Timeframe: 24 months

Trial details

NCT IDNCT03806426

SponsorS.L.A. Pharma AG

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-06-30

View on ClinicalTrials.gov More Familial Adenomatous Polyposis trials