Familial Adenomatous PolyposisPhase 3NCT03806426
Effect of EPA-FFA on Polypectomy in Familial Adenomatous Polyposis
A Phase 3 study testing Eicosapentaenoic acid free fatty acid (EPA-FFA) in people with Familial Adenomatous Polyposis, run by S.L.A. Pharma AG at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Familial Adenomatous Polyposis
- What is being tested?
- Eicosapentaenoic acid free fatty acid (EPA-FFA)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 204 participants
- Where
- 1 siteItaly
- Study dates
- 5 Dec 2018to 31 Jul 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- Subjects who have significant abnormalities on their screening blood tests.
- Subjects with gastrointestinal malabsorptive disease.
- Subjects with uncontrolled hypercholesterolaemia.
- Subjects who are deemed mentally incompetent or have a history of anorexia nervosa or bulimia.
- 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.
- Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless surgically sterile, must use effective contraception (either combined oestrogen 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site
University of Bologna and St.Orsola-Malpighi Hospital
Bologna, 40138
About this study
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)
2 Year randomised, double-blind, placebo-controlled, parallel group study to determine the safety and efficacy of EPA-FFA gastro resistant capsules in FAP.
Read the 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.
- Conditions
- Familial Adenomatous Polyposis
- Being tested
- Eicosapentaenoic acid free fatty acid (EPA-FFA), Placebo
- Keywords
- Eicosapentaenoic Acid, EPA, EPA 99%, Fatty Acid, omega-3, polyp, Familial Adenomatous Polyposis, FAP, IRA (Ileo-rectal anastomosis), PUFA (polyunsaturated fatty acid), Endoscopy
- Medical subject headings
- Adenomatous Polyposis Coli, Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eicosapentaenoic acid free fatty acid (EPA-FFA)Drug
Also called ALFA
500mg capsule, two 500mg capsules to be taken twice daily for 24 months
PlaceboDrug
500mg capsule, two 500mg capsules to be taken twice daily for 24 months
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group A | Experimental | Eicosapentaenoic acid free fatty acid (EPA-FFA) 500mg Receives: Drug: Eicosapentaenoic acid free fatty acid (EPA-FFA) |
| Treatment Group B | Placebo comparator | Placebo 500mg Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
Secondary outcomes (2)
Change in Polyp number at 24 months assessed by blinded review of video records
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.
Measured: 24 months
Change in score on the InSIGHT Polyposis Staging System (IPSS) at 24 months
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
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2019
- Study start5 Dec 2018
- Primary completion30 Jun 2024 (estimated)
- Study completion31 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Familial Adenomatous PolyposisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- S.L.A. Pharma AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Luigi Ricciardiello, MD, Principal investigator, Associate Professor of Gastroenterology, University of Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03806426
- Sponsor's protocol ID
- EPA-POL-04
- Status last verified
- Apr 2024
- First submitted
- 9 Jan 2019
- Last updated
- 25 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03806426
- Acronym / sponsor ID
- EPA-POL-04
- Conditions
- Familial Adenomatous Polyposis
- Keywords
- Eicosapentaenoic Acid, EPA, EPA 99%, Fatty Acid, omega-3, polyp, Familial Adenomatous Polyposis, FAP
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- S.L.A. Pharma AGIndustry (pharma, biotech, devices)
- Study start
- 5 Dec 2018 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 16 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group A | Experimental | Drug: Eicosapentaenoic acid free fatty acid (EPA-FFA)Eicosapentaenoic acid free fatty acid (EPA-FFA) 500mg |
| Treatment Group B | Placebo comparator | Drug: PlaceboPlacebo 500mg |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eicosapentaenoic acid free fatty acid (EPA-FFA)Also: ALFA500mg capsule, two 500mg capsules to be taken twice daily for 24 months | Drug | Treatment Group A |
| Placebo500mg capsule, two 500mg capsules to be taken twice daily for 24 months | Drug | Treatment Group B |
Primary outcome
Total Number of Polypectomies (polyps > 5mm in the rectum) conducted during the 24 months study period
Time frame: 24 months
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.
2 secondary outcomes
Change in Polyp number at 24 months assessed by blinded review of video records
Time frame: 24 months
Change in score on the InSIGHT Polyposis Staging System (IPSS) at 24 months
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luigi Ricciardiello, MD principal investigator
Associate Professor of Gastroenterology, University of Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Eicosapentaenoic acid free fatty acid (EPA-FFA) in people with Familial Adenomatous Polyposis, run by S.L.A. Pharma AG at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Number of Polypectomies (polyps > 5mm in the rectum) conducted during the 24 months study period (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2024.