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.
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
Drug | Synonyms | Arms |
---|
Eicosapentaenoic acid free fatty acid (EPA-FFA) | ALFA | Treatment Group A |
Placebo | | Treatment Group B |
Purpose
2 Year randomised, double-blind, placebo-controlled, parallel group study to determine the
safety and efficacy of EPA-FFA gastro resistant capsules in FAP.
Detailed Description
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. Planned Sample Size This study will
enrol 204 subjects (102 subjects per treatment group). Primary Objective is to determine the
efficacy of EPA-FFA gastro-resistant capsules in patients with FAP in reducing polypectomy.
Secondary objectives is to evaluate the clinical disease progression and the long-term safety
and tolerability of EPA-FFA.
Trial Arms
Name | Type | Description | Interventions |
---|
Treatment Group A | Experimental | Eicosapentaenoic acid free fatty acid (EPA-FFA) 500mg | - Eicosapentaenoic acid free fatty acid (EPA-FFA)
|
Treatment Group B | Placebo Comparator | Placebo 500mg | |
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: | 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. |
Secondary Outcome Measures
Measure: | Change in Polyp number at 24 months assessed by blinded review of video records |
Time Frame: | 24 months |
Safety Issue: | |
Description: | Subsequent 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. |
Measure: | Change in score on the InSIGHT Polyposis Staging System (IPSS) at 24 months |
Time Frame: | 24 months |
Safety Issue: | |
Description: | Classified stage on InSiGHT Polyposis Staging System (IPSS). The subjects FAP will be classified in accordance with the IPSS.
The IPSS classification will be verified by the Polyp Video Scoring committee |
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
Last Updated
July 14, 2021