NL-OMON55587已完成3 期
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) - EPA-FFA in FAP
SLA Pharma0 个研究点目标入组 30 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •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.
排除标准
- •1. In subjects with previous ileo-rectal anastomosis * 20 polyps > 5mm in the
- •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
- •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
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