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NCT02391571 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate Withdrawal Effects Following Dosing of Oxycodone/Naltrexone in Methadone-Maintained Subjects
A Phase 3 study, sponsored by Elite Laboratories.
- Completed
- Registry status
- Phase 3
- Development phase
- 26
- Enrollment target
NCT02391571: Completed Phase 3 study, sponsored by Elite Laboratories.
NCT02391571 is a Phase 3 study that has completed, run by Elite Laboratories. The registered enrollment target is 26 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02391571, a Phase 3 study, has completed, sponsored by Elite Laboratories.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 26 participants
- Enrollment target
Study Summary
This single-center study is a randomized, double-blind, active-controlled, multiple-dose, parallel group study to evaluate the potential withdrawal effects, safety and tolerability, and pharmacokinetic and pharmacodynamic effects of multiple doses of oral intact Oxycodone/Naltrexone capsules compared to oxycodone in methadone-maintained opioid-dependent subjects. The study will consist of a Screening Phase, an inpatient Treatment Phase (including a methadone stabilization period, a placebo administration period, a treatment administration period and a safety/washout period), and a Follow-up Phase.
Interventions
- DRUG Placebo
- DRUG Oxycodone
- DRUG Oxycodone/Naltrexone Capsules
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2015-02 |
| Est. Completion | 2015-03 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02391571
The ClinicalTrials.gov registry entry for NCT02391571 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Elite Laboratories, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02391571 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02391571 about?
NCT02391571 is a clinical study titled "A Study to Evaluate Withdrawal Effects Following Dosing of Oxycodone/Naltrexone in Methadone-Maintained Subjects". This single-center study is a randomized, double-blind, active-controlled, multiple-dose, parallel group study to evaluate the potential withdrawal effects, safety and tolerability, and pharmacokinetic and pharmacodynamic effects of multiple doses of oral intact Oxycodone/Naltrexone capsules compare...
What is the current status of trial NCT02391571?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 26 participants. The study started on 2015-02. Estimated completion is 2015-03.
What interventions are being tested in trial NCT02391571?
The interventions under investigation include: Placebo (DRUG), Oxycodone (DRUG), Oxycodone/Naltrexone Capsules (DRUG).
Who is sponsoring clinical trial NCT02391571?
This trial is sponsored by Elite Laboratories, which has 2 total clinical trials registered on ClinicalTrials.gov.
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