At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 81 enrolled
Drug / intervention
AMR101drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
PREPARE: PRevention Using EPA Against coloREctal Cancer
In Brief
A Phase 2 clinical trial evaluating AMR101 for Colorectal Adenoma and 4 related conditions. Completed, enrolled 81 participants across 1 site.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsColorectal Adenoma, Colorectal Cancer, Endoscopic Surgery, Eicosapentaenoic Acid, Gastrointestinal Microbiome
CountriesUnited States
CollaboratorsNational Institutes of Health (NIH)
Timeline
Phase 2CompletedFinished
2020202120222023202420252026
First PostedJan 2020
Enrollment StartDec 2020
Primary CompletionSep 2022
TodayJul 2026
First PostedJan 2, 2020
Enrollment StartDec 9, 2020
Primary CompletionSep 30, 2022
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 6.5 years ago
Interventions
AMR101drug
AMR101-oral predetermined protocol dosage, daily for a minimum of 8 weeks and maximum of 12 weeks