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Effect of EPA-FFA on Polypectomy in Familial Adenomatous Polyposis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03806426
Recruitment Status : Recruiting
First Posted : January 16, 2019
Last Update Posted : June 18, 2019
Sponsor:
Information provided by (Responsible Party):
S.L.A. Pharma AG

Tracking Information
First Submitted Date  ICMJE January 9, 2019
First Posted Date  ICMJE January 16, 2019
Last Update Posted Date June 18, 2019
Actual Study Start Date  ICMJE December 5, 2018
Estimated Primary Completion Date March 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 14, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 15, 2019)
Total Number of Polypectomies (polyps > 5mm in the rectum) conducted during the 24 months study period [ Time Frame: 24 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 14, 2019)
  • Change in Polyp number at 24 months assessed by blinded review of video records [ Time Frame: 24 months ]
    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.
  • Change in score on the InSIGHT Polyposis Staging System (IPSS) at 24 months [ Time Frame: 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
Original Secondary Outcome Measures  ICMJE
 (submitted: January 15, 2019)
  • Change in score on the InSIGHT Polyposis Staging System (IPSS) at 24 months [ Time Frame: 24 months ]
  • Change in Polyp number at 24 months assessed by blinded review of video records [ Time Frame: 24 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of EPA-FFA on Polypectomy in Familial Adenomatous Polyposis
Official Title  ICMJE 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)
Brief 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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Familial Adenomatous Polyposis
Intervention  ICMJE
  • Drug: Eicosapentaenoic acid free fatty acid (EPA-FFA)
    500mg capsule, two 500mg capsules to be taken twice daily for 24 months
    Other Name: ALFA
  • Drug: Placebo
    500mg capsule, two 500mg capsules to be taken twice daily for 24 months
Study Arms  ICMJE
  • Experimental: Treatment Group A
    Eicosapentaenoic acid free fatty acid (EPA-FFA) 500mg
    Intervention: Drug: Eicosapentaenoic acid free fatty acid (EPA-FFA)
  • Placebo Comparator: Treatment Group B
    Placebo 500mg
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 15, 2019)
204
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 1, 2021
Estimated Primary Completion Date March 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Justin Slagel, CEO +44 1923 681001 info@slapharma.com
Listed Location Countries  ICMJE Czechia,   France,   Israel,   Italy,   Netherlands,   Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03806426
Other Study ID Numbers  ICMJE EPA-POL-04
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party S.L.A. Pharma AG
Study Sponsor  ICMJE S.L.A. Pharma AG
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Luigi Ricciardiello, MD Associate Professor of Gastroenterology, University of Bologna
PRS Account S.L.A. Pharma AG
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP