This research study is evaluating the effect of AMR101 as a possible chemopreventive agent to
reduce risk of colorectal cancer in individuals with a history of colorectal adenoma.
The name of the study drug involved in this study is:
-- AMR101 (VASCEPA).
This prospective, single-arm, research study evaluating the effect of AMR101, as a
chemopreventive agent to reduce risk of colorectal cancer in individuals with a history of
AMR101 is made of marine omega-3 fatty acid, which is a family of natural substances
found in the oil of certain fish, such as salmon and mackerel. Marine omega-3 fatty acid
cannot be produced in sufficient amount by the human body and has to be obtained through
diet or supplemented to maintain normal function in the body.
The U.S. Food and Drug Administration (FDA) has not approved AMR101 as a treatment for
AMR101 is commercially available in the US as VASCEPA (icosapent ethyl)
The research study procedures include screening for eligibility and study treatment
including evaluations and follow up visits, including:
Flexible sigmoidoscopy (24 biopsies of normal colorectal mucosa, one stool sample)
AMR101 administered daily, orally for 8-12 weeks and it is expected 80 participants will
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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