Familial adenomatous polyposis (FAP) MedDRA version: 8.1 Level: LLT Classification code 10059327 Term: Familial adenomatous polyposis
Conditions
Interventions
Product Name: Eicosapentaenoic acid, free fatty acid
Product Code: EPA 99%
Pharmaceutical Form: Capsule, soft
CAS Number: 25378272
Other
Sponsors
S.L.A. Pharma (UK) Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients must have a known diagnosis of FAP and have had a previous colectomy with ileo-rectal anastomosis. • Males or females aged 18 and over • Patients of child-bearing potential must demonstrate a negative pregnancy test at screening, and should use a reliable form of contraception during the trial and for 1 month afterwards, e.g.: - Oral contraceptive + condom - Intra-uterine device (IUD)+ condom - Diaphragm with spermicide + condom • Male partners of women of child bearing potential should use a reliable form of contraception during the trial and for 1 month afterwards, e.g.: - Oral contraceptive + condom - Intra-uterine device (IUD)+ condom - Diaphragm with spermicide + condom • Rectal polyp status: the patient has an endoscopically assessable rectal segment. • Patients must show a willingness to abstain from regular use of non-steroidal anti-inflammatory medication for the duration of the study. A cardioprotective dose of aspirin (75mg) may be permitted. • Patients must have provided written informed consent to participate 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • History of invasive carcinoma in the past 5 years other than resected Duke’s A/B1 colon cancer or resected non-melanomatous skin cancer • Partial or complete colectomy within 12 months prior to enrolment. • History of pelvic radiation • Patients who are allergic to fish • Patients who have diabetes mellitus • Patients who are pregnant or breast-feeding • Patients taking aspirin or other non-steroidal anti-inflammatory drugs on a regular basis other than low dose cardioprotective dose. • Patients who have aspirin-sensitive asthma • Patients suffering from haemorrhagic disorders • Patients who are taking warfarin or other anticoagulants • Patients who have significant abnormalities on their screening blood tests • Patients taking lipid lowering medication • Patients with gastrointestinal malabsorptive disease • Patients who are taking other fish-oil supplements (e.g. cod liver oil) who are unwilling to stop them for the duration of the study. Patients previously taking fish oil must have a washout period of 1 month prior to study enrolment. • Patients who are deemed mentally incompetent, or have a history of anorexia nervosa or bulimia • Patients with a history of alcohol or drug abuse, including laxative abuse • Patients considered by their physician unlikely to be able to comply with the protocol. • Patients who have taken part in an experimental drug study in the preceding 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether the polyp burden of patients with genetically determined colorectal polyp syndrome (namely Familial Polyposis Coli) be reduced by regular treatment with high concentration eicosapentaenoic acid (EPA) as the free fatty acid.;Primary end point(s): The percentage change from baseline in the number of polyps measured within a defined focal area of the rectum in FAP patients with a history of colectomy and ileo-rectal anastomosis.; Secondary Objective: To analyse the uptake of EPA into the lining of the large bowel. To compare the changes in cell turnover in the rectal mucosa, using cellular markers, before and after treatment. To determine the safety and tolerability of EPA. | — |
Countries
United Kingdom
Outcome results
None listed