2 Year randomised, double-blind, placebo-controlled, parallel group study to determine the safety and efficacy of EPA-FFA gastro resistant capsules in FAP.
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
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
204
500mg capsule, two 500mg capsules to be taken twice daily for 24 months
500mg capsule, two 500mg capsules to be taken twice daily for 24 months
University of Bologna and St.Orsola-Malpighi Hospital
Bologna, Italy
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.
Time frame: 24 months
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.
Time frame: 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
Time frame: 24 months
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