Effects of EPA-FFA on polypectomy in familial adenomatous polyposis.

Phase 1

Conditions: Familial Adenomatous Polyposis (FAP)
MedDRA version: 20.1Level: LLTClassification code 10059327Term: Familial adenomatous polyposisSystem Organ Class: 100000004850
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Registration Number: EUCTR2017-002809-34-PL

Lead Sponsor: SLA Pharma (UK) Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 204

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 antiinflammatory medication for the trial. A cardio protective dose of aspirin (75mg- 100mg) will be permitted.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 204
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Subjects with ileo-rectal anastomosis who have = 20 polyps which are of >5mm that are not amendable to removal in the rectum.
2. Subjects with an ileo-anal pouch.
3. Subjects unwilling to have regular sigmoidoscopy 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) cardio protective dose. Regular use of other
non-steroidal anti-inflammatory drugs (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.
11. Subjects taking NSAIDs regularly in the 3 months prior to entry (other than low dose aspirin).
12. Subjects taking NSAID, 5-aminosalicylic acid (5-ASA or mesalamine).
13. 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.
14. Subjects who are taking warfarin or other anticoagulants.
15. 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).
16. Subjects suffering from known disorders of clotting and blood coagulation
17. Subjects who have significant abnormalities on their screening blood tests.
18. Subjects with gastrointestinal malabsorptive disease.
19. Subjects with uncontrolled hypercholesterolaemia.
20. Subjects who are deemed mentally incompetent or have a history of anorexia nervosa or bulimia.
21. 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.
22. 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 subject’s usual and preferred lifestyle), combination of male
condom with either cap, diaphragm or sponge with spermicide [double barrier methods]), and be willing to continue contraception for 1 month after the last
administration of IMP.
23. 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”.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine the efficacy of EPA-FFA gastro-resistant capsules in patients with FAP in reducing polypectomy.;Secondary Objective: Evaluate the clinical disease progression.<br>Evaluate the long-term safety and tolerability of EPA-FFA.;Primary end point(s): Total number of polypectomies (polyps >5mm in the rectum) conducted during the 24 months study period.;Timepoint(s) of evaluation of this end point: Study End (24 months after subject enrolment)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Change in polyp number at 24 months assessed by blinded review of video records.<br>Change in score on the InSiGHT Polyposis Staging System (IPSS) at 24 months.<br>Number of subjects requiring surgical intervention (not including polypectomies).<br>Total number of polypectomies (polyps >5mm in the rectum) conducted at 6 months, 12 months, 18 months.<br>Change in polyp number at 6 months, 12 months, 18 months assessed by blinded review of video records.<br>Change in score on the InSiGHT Polyposis Staging System (IPSS) at 6 months, 12 months, and 18 months.<br>Time to surgical intervention (not including polypectomies).<br>Change in score on the Spigelman Classification of Duodenal Polyposis at 24 months.<br>Patient’s Global Impression of Improvement (PGI-I) at Months 6, 12, 18 and 24.;Timepoint(s) of evaluation of this end point: Study End (24 months after subject enrolment)

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