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NCT00834080 · ClinicalTrials.gov registry record · Phase 3
ALK21-021: A Safety Study of Medisorb® Naltrexone (VIVITROL®) Administered to Health Care Professionals
A Phase 3 study, sponsored by Alkermes.
- Completed
- Registry status
- Phase 3
- Development phase
- 38
- Enrollment target
NCT00834080: Completed Phase 3 study, sponsored by Alkermes.
NCT00834080 is a Phase 3 study that has completed, run by Alkermes. The registered enrollment target is 38 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00834080, a Phase 3 study, has completed, sponsored by Alkermes.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 38 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the safety and tolerability of Medisorb® naltrexone (VIVITROL®) when administered over a period of 24 months to health care professionals who have a history of opioid dependence.
Primary Outcome
A TEAE is any adverse event (AE), whether or not considered drug-related, that develops or worsens in severity after study drug administration begins (ie, from the first administration through the end of the follow-up period).
Interventions
- DRUG Medisorb naltrexone 380 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2009-03 |
| Est. Completion | 2012-05 |
| Phase | Phase 3 |
What the finished NCT00834080 record still lists
NCT00834080 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 1 intervention - of which Medisorb naltrexone 380 mg is the first listed.
NCT00834080 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00834080 about?
NCT00834080 is a clinical study titled "ALK21-021: A Safety Study of Medisorb® Naltrexone (VIVITROL®) Administered to Health Care Professionals". The purpose of this study is to determine the safety and tolerability of Medisorb® naltrexone (VIVITROL®) when administered over a period of 24 months to health care professionals who have a history of opioid dependence.
What is the current status of trial NCT00834080?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 38 participants. The study started on 2009-03. Estimated completion is 2012-05.
What interventions are being tested in trial NCT00834080?
The interventions under investigation include: Medisorb naltrexone 380 mg (DRUG).
Who is sponsoring clinical trial NCT00834080?
This trial is sponsored by Alkermes, which has 66 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00834080's enrollment target sits among peer trials
38 1900th of 2000 higher than 100 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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