Effect of EPA-FFA on Polypectomy in Familial Adenomatous Polyposis

NCT03806426 | Active Not Recruiting Phase 3 DMC

• 1 other identifier: EPA-POL-04
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

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.

Conditions

Familial Adenomatous Polyposis

Keywords

Eicosapentaenoic Acid; EPA; EPA 99%; Fatty Acid; omega-3; polyp; Familial Adenomatous Polyposis; FAP; IRA (Ileo-rectal anastomosis); PUFA (polyunsaturated fatty acid); Endoscopy

Outcome Measures

Primary Outcomes (1)

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

  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.

  24 months

Secondary Outcomes (2)

• Change in Polyp number at 24 months assessed by blinded review of video records

  24 months

• Change in score on the InSIGHT Polyposis Staging System (IPSS) at 24 months

  24 months

Study Arms (2)

Treatment Group A

EXPERIMENTAL

Eicosapentaenoic acid free fatty acid (EPA-FFA) 500mg

Drug: Eicosapentaenoic acid free fatty acid (EPA-FFA)

Treatment Group B

PLACEBO COMPARATOR

Placebo 500mg

Drug: Placebo

Interventions

Eicosapentaenoic acid free fatty acid (EPA-FFA) DRUG

500mg capsule, two 500mg capsules to be taken twice daily for 24 months

Also known as: ALFA

Treatment Group A

Placebo DRUG

500mg capsule, two 500mg capsules to be taken twice daily for 24 months

Treatment Group B

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Subjects taking aspirin, other than a low (75mg-100mg) cardioprotective dose on a regular basis, or other nonsteroidal anti-inflammatory drugs (NSAIDs) on a regular basis. Regular use of other NSAIDS is defined in this protocol as use greater than 14-day treatment period, and one treatment per six months for the duration of the study.
• Subjects taking NSAIDs regularly in the 3 months prior to entry (other than low dose aspirin).
• Subjects taking NSAID, 5-aminosalicylic acid (5-ASA or mesalamine).
• Subjects who are taking other fish-oil supplements (e.g. cod liver oil) who are unwilling to stop them for the duration of the study. Subjects previously taking fish oil must have a washout period of 2 months prior to study enrolment.
• Subjects who are taking warfarin or other anticoagulants.
• Experimental agents must have been discontinued at least 8 weeks prior to screening or for a period equivalent to 5 half-lives of the agent (whichever is longer).
• Subjects suffering from known disorders of clotting and blood coagulation.

Sponsors & Collaborators

• S.L.A. Pharma AG: lead

Study Sites (1)

University of Bologna and St.Orsola-Malpighi Hospital

Bologna, 40138, Italy

Location

MeSH Terms

Conditions

Adenomatous Polyposis Coli; Polyps

Interventions

Docosahexaenoic Acids

Condition Hierarchy (Ancestors)

Adenomatous Polyps; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplastic Syndromes, Hereditary; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Polyposis; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Officials

• Luigi Ricciardiello, MD

  Associate Professor of Gastroenterology, University of Bologna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2019
• First Posted: January 16, 2019
• Study Start: December 5, 2018
• Primary Completion: June 30, 2024
• Study Completion: July 31, 2024
• Last Updated: April 25, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)