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)
- Conditions
- 10017991FAPhereditary development of polyps in colon10018018
- Registration Number
- NL-OMON55587
- Lead Sponsor
- SLA Pharma
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
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
anastomosis.
4. Patients have had a previous colectomy with an ileo-rectal anastomosis or an
ileal pouch- anal anastomosis with a rectal remnant of * 2cm
5. Classified stage 1-3 on InSiGHT Polyposis Staging System (IPSS).
6. Subjects must show a willingness to abstain from regular use of nonsteroidal
anti-inflammatory medication for the trial. A cardioprotective dose of aspirin
(75mg-100mg) will be permitted.
1. In subjects with previous ileo-rectal anastomosis * 20 polyps > 5mm in the
rectum.
2. Subjects unwilling to have regular endoscopic examination.
3. Subjects who are due to undergo gastro-intestinal surgery related to FAP.
4. History of invasive carcinoma in the past 3 years.
5. History of pelvic radiation.
6. Known allergic reaction or intolerant to fish or fish oils.
7. Known allergic reaction to excipients of IMP and placebo.
8. Subjects who are pregnant or breast-feeding at screening.
9. Subjects taking aspirin or other non-steroidal anti-inflammatory drugs on a
regular basis other than low dose (75mg-100mg) cardioprotective dose.
10. Subjects taking NSAIDs regularly in the 3 months prior to entry (other than
low dose aspirin).
11. Subjects taking NSAID, 5-aminosalicylic acid (5-ASA or mesalamine).
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 beenconfirmed to be in the *postmenopausal range*. Or have had
a surgical bilateral oophorectomy (with or without hysterectomy) or bilateral
tubal ligation at leas
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary Endpoint<br /><br>* Total number of polypectomies (polyps >5 mm in the rectum) conducted during<br /><br>the 24 months study period.<br /><br><br /><br>Safety Endpoints<br /><br>The safety analysis will be conducted in all randomised subjects receiving at<br /><br>least one dose.<br /><br>* The number and proportion of subjects with AEs.<br /><br>* The number of subjects requiring hospitalisation.<br /><br>* Assessment of clinical laboratory parameters.<br /><br>* Assessment of vital signs.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary Endpoints<br /><br>* Change in polyp number at 24 months assessed by blinded review of video<br /><br>records.<br /><br>* Change in score on the InSiGHT Polyposis Staging System (IPSS) at 24 months.<br /><br>* Number of subjects requiring surgical intervention (not including<br /><br>polypectomies).<br /><br>* Total number of polypectomies (polyps >5mm in the rectum) conducted at 6<br /><br>months, 12 months, 18 months.<br /><br>* Change in polyp number at 6 months, 12 months, 18 months assessed by blinded<br /><br>review of video records.<br /><br>* Change in score on the InSiGHT Polyposis Staging System (IPSS) at 6 months,<br /><br>12 months, 18 months.<br /><br>* Time to surgical intervention (not including polypectomies).<br /><br>* Change in score on the Spigelman Classification of Duodenal Polyposis at 24<br /><br>months.<br /><br>* Patient*s Global Impression of Improvement (PGI-I) at Months 6, 12, 18 and<br /><br>24.</p><br>