Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2025-12-24 @ 11:56 PM
NCT ID:
NCT04216251
Brief Summary:
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).
Detailed Description:
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 colorectal adenoma.
* 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 any disease.
* 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:
* Lifestyle questionnaire,
* Nutritional survey
* Flexible sigmoidoscopy (24 biopsies of normal colorectal mucosa, one stool sample)
* Blood samples,
* AMR101 administered daily, orally for 8-12 weeks and it is expected 80 participants will take part.
Study:
NCT04216251
Study Brief:
Protocol Section:
NCT04216251