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NCT03818399 · ClinicalTrials.gov registry record · Phase 3
Virginia Opioid Overdose Treatment InitiatVE
A Phase 3 study, sponsored by Virginia Commonwealth University.
- Terminated
- Registry status
- Phase 3
- Development phase
- 19
- Enrollment target
NCT03818399 is a Phase 3 study that was terminated before completion, run by Virginia Commonwealth University. The registered enrollment target is 19 participants.
The verdict
NCT03818399, a Phase 3 study, was terminated before completion, sponsored by Virginia Commonwealth University.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 19 participants
- Enrollment target
Study Summary
This is a Phase 3b, open-label study in patients that present to the ED for an opioid OD and receive treatment with an opioid antagonist. The study is designed to determine effect of SUBLOCADE on repeat overdose and death compared to historical control data. The study will assess subjects that receive acute administration of SUBOXONE sublingual film in the Emergency Department (ED) followed by SUBLOCADE administration in the ED and referral to an affiliated outpatient treatment clinic, compared to historical control data from electronic health records.
Interventions
- DRUG SUBLOCADE
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2019-01-04 |
| Est. Completion | 2021-02-24 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03818399
The ClinicalTrials.gov registry entry for NCT03818399 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Virginia Commonwealth University, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which SUBLOCADE is the first listed.
NCT03818399 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03818399 about?
NCT03818399 is a clinical study titled "Virginia Opioid Overdose Treatment InitiatVE". This is a Phase 3b, open-label study in patients that present to the ED for an opioid OD and receive treatment with an opioid antagonist. The study is designed to determine effect of SUBLOCADE on repeat overdose and death compared to historical control data. The study will assess subjects that rece...
What is the current status of trial NCT03818399?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 19 participants. The study started on 2019-01-04. Estimated completion is 2021-02-24.
What interventions are being tested in trial NCT03818399?
The interventions under investigation include: SUBLOCADE (DRUG).
Who is sponsoring clinical trial NCT03818399?
This trial is sponsored by Virginia Commonwealth University, which has 558 total clinical trials registered on ClinicalTrials.gov.
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