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PRevention Using EPA Against coloREctal Cancer

NCT04216251 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2024-05-03

Study results available
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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).

Conditions

  • Colorectal Adenoma
  • Colorectal Cancer
  • Endoscopic Surgery
  • Eicosapentaenoic Acid
  • Gastrointestinal Microbiome

Interventions

DRUG

AMR101

AMR101-oral predetermined protocol dosage, daily for a minimum of 8 weeks and maximum of 12 weeks

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Mingyang Song, MD · Massachusetts General Hospital

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-09
Primary Completion
2022-09-30
Completion
2022-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04216251 on ClinicalTrials.gov