Clinical Trials /

Effect of EPA-FFA on Polypectomy in Familial Adenomatous Polyposis

NCT03806426

Description:

2 Year randomised, double-blind, placebo-controlled, parallel group study to determine the safety and efficacy of EPA-FFA gastro resistant capsules in FAP.

Related Conditions:
  • Familial Adenomatous Polyposis
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: Effect of EPA-FFA on Polypectomy in Familial Adenomatous Polyposis
  • 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)

Clinical Trial IDs

  • ORG STUDY ID: EPA-POL-04
  • NCT ID: NCT03806426

Conditions

  • Familial Adenomatous Polyposis

Interventions

DrugSynonymsArms
Eicosapentaenoic acid free fatty acid (EPA-FFA)ALFATreatment Group A
PlaceboTreatment Group B

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Treatment Group AExperimentalEicosapentaenoic acid free fatty acid (EPA-FFA) 500mg
  • Eicosapentaenoic acid free fatty acid (EPA-FFA)
Treatment Group BPlacebo ComparatorPlacebo 500mg
  • Placebo

Eligibility Criteria

        Inclusion Criteria

          1. Must give written informed consent.

          2. Male or female subjects, 18 to 65 years of age.

          3. Known diagnosis of FAP defined as those with a pathogenic APC mutation and have had a
             previous colectomy with ileo-rectal anastomosis.

          4. Subjects must have a preserved rectum.

          5. Classified stage 1-3 on InSiGHT Polyposis Staging System (IPSS).

          6. Subjects must show a willingness to abstain from regular use of non-steroidal
             anti-inflammatory medication for the trial. A cardioprotective dose of aspirin
             (75mg-100mg) will be permitted.

        Exclusion Criteria:

          1. In subjects with previous ileo-rectal anastomosis ≥ 20 polyps > 5mm in the rectum.

          2. Subjects with an ileo-anal pouch.

          3. Subjects unwilling to have regular endoscopic examination.

          4. Subjects who are due to undergo gastro-intestinal surgery related to FAP.

          5. History of invasive carcinoma in the past 3 years.

          6. History of pelvic radiation.

          7. Known allergic reaction or intolerant to fish or fish oils.

          8. Known allergic reaction to excipients of IMP and placebo.

          9. Subjects who are pregnant or breast-feeding at screening.

         10. Subjects taking aspirin or other non-steroidal anti-inflammatory drugs on a regular
             basis other than low dose (75mg-100mg) cardioprotective dose.

         11. Subjects taking NSAIDs regularly in the 3 months prior to entry (other than low dose
             aspirin).

         12. 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.

         13. Subjects who are taking warfarin or other anticoagulants.

         14. Experimental agents must have been discontinued at least 8 weeks prior to screening
             for a period equivalent to 5 half-lives of the agent (whichever is longer).

         15. Subjects suffering from known disorders of clotting and blood coagulation.

         16. Subjects who have significant abnormalities on their screening blood tests.

         17. Subjects with gastrointestinal malabsorptive disease.

         18. Subjects with uncontrolled hypercholesterolaemia.

         19. Subjects who are deemed mentally incompetent, or have a history of anorexia nervosa or
             bulimia.

         20. Subjects who will be unavailable for the duration of the trial, deemed unable to
             comply with the requirements of the study protocol, likely to be noncompliant with the
             protocol, or who are felt to be unsuitable by the Investigator for any other reason.

         21. Women of childbearing potential, defined as all women physiologically capable of
             becoming pregnant, unless surgically sterile must use effective contraception (either
             combined estrogen and progestogen containing hormonal contraception associated with
             inhibition of ovulation [oral, intravaginal, transdermal], progestogen only hormonal
             contraception associated with inhibition of ovulation [oral, injectable, implantable],
             intrauterine device [IUD], intrauterine hormone-releasing system [IUS], vasectomised
             partner, sexual abstinence (only considered an acceptable method of contraception when
             it is in line with the subjects' usual and preferred lifestyle), combination of male
             condom with either cap, diaphragm or sponge with spermicide [double barrier methods]),
             and willing and able to continue contraception for 1 month after the last
             administration of IMP. Women using oral contraception must have started using it at
             least 2 months prior to screening. Women are not considered to be of childbearing
             potential if they have had 12 months of natural (spontaneous) amenorrhea with an
             appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or
             six months of spontaneous amenorrhea with serum FSH levels that have been confirmed to
             be in the "postmenopausal range". Or have had a surgical bilateral oophorectomy (with
             or without hysterectomy) or bilateral tubal ligation at least six weeks before the
             screening visit. In case of oophorectomy alone, the reproductive status of the woman
             should have been confirmed by follow up hormone level assessment.
      
Maximum Eligible Age:65 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Total Number of Polypectomies (polyps > 5mm in the rectum) conducted during the 24 months study period
Time Frame:24 months
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Change in score on the InSIGHT Polyposis Staging System (IPSS) at 24 months
Time Frame:24 months
Safety Issue:
Description:
Measure:Change in Polyp number at 24 months assessed by blinded review of video records
Time Frame:24 months
Safety Issue:
Description:

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:S.L.A. Pharma AG

Trial Keywords

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

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