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-NL
• Lead Sponsor: SLA Pharma UK Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-13
• Last Update Posted: 1 October 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• 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 anti-inflammatory medication for the trial. A cardioprotective 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.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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified