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NCT04216251 · ClinicalTrials.gov registry record · Phase 1
PRevention Using EPA Against coloREctal Cancer
A Phase 1 study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 1
- Development phase
- 81
- Enrollment target
NCT04216251: Completed Phase 1 study, sponsored by Massachusetts General Hospital.
NCT04216251 is a Phase 1 study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 81 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (35% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04216251, a Phase 1 study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 81 participants
- Enrollment target
Study 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).
Primary Outcome
Measured using the extraction of fatty acid with gas chromatography-mass spectrometry from the biopsy tissue.
Interventions
- DRUG AMR101
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 81 participants |
| Start Date | 2020-12-09 |
| Est. Completion | 2022-09-30 |
| Phase | Phase 1 |
What the finished NCT04216251 record still lists
NCT04216251 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 81 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (35% higher).
The record links to 0 conditions, and to 1 intervention - of which AMR101 is the first listed.
NCT04216251 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04216251 about?
NCT04216251 is a clinical study titled "PRevention Using EPA Against coloREctal Cancer". 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).
What is the current status of trial NCT04216251?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 81 participants. The study started on 2020-12-09. Estimated completion is 2022-09-30.
What interventions are being tested in trial NCT04216251?
The interventions under investigation include: AMR101 (DRUG).
Who is sponsoring clinical trial NCT04216251?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04216251's enrollment target sits among peer trials
81 671st of 2000 higher than 1,329 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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