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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, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower). 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.
Primary Outcome
To assess the withdrawal effects of intact Oxycodone/Naltrexone following multiple dose administration compared to Oxycodone in methadone-maintained, opioid-dependent subjects (all subjects enrolled in the study N=34) over time using Subjective Opioid Withdrawal Scale(SOWS), a set of 16 questions scored on a scale of 0-4 (not at all to extremely) according to how the subject feels at that moment to the questions asked about withdrawal symptoms. The questions are asked during the placebo period 9
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 |
What the finished NCT02391571 record still lists
NCT02391571 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02391571 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02391571's enrollment target sits among peer trials
26 1937th of 2000 higher than 60 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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