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NCT01903005 · ClinicalTrials.gov registry record · Phase 4
Multi-Center, Open-Label, 24-Week Study of OX219 Safety and Efficacy for Maintenance Treatment of Opioid Dependence
A Phase 4 study, sponsored by Orexo AB.
- Completed
- Registry status
- Phase 4
- Development phase
- 668
- Enrollment target
NCT01903005: Completed Phase 4 study, sponsored by Orexo AB.
NCT01903005 is a Phase 4 study that has completed, run by Orexo AB. The registered enrollment target is 668 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (29% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01903005, a Phase 4 study, has completed, sponsored by Orexo AB.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 668 participants
- Enrollment target
Study Summary
The purpose of this study was to assess safety, efficacy, and treatment retention following extended treatment with OX219, a higher-bioavailability buprenorphine/naloxone (BNX) sublingual tablet formulation in opioid-dependent patients who completed 1 of 2 primary efficacy and safety studies of OX219.
Primary Outcome
Number of patients reporting treatment-emergent adverse events during open-label, extension treatment with higher bioavailability BNX sublingual tablets
Interventions
- DRUG Higher bioavailability BNX sublingual tablets
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 668 participants |
| Start Date | 2013-07 |
| Est. Completion | 2014-09 |
| Phase | Phase 4 |
What the finished NCT01903005 record still lists
NCT01903005 is an interventional study that assigns participants to a tested intervention. The registered 668 participants enrollment target is mid-sized for trials with a published cap, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (29% higher).
The record links to 0 conditions, and to 1 intervention - of which Higher bioavailability BNX sublingual tablets is the first listed.
NCT01903005 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01903005 about?
NCT01903005 is a clinical study titled "Multi-Center, Open-Label, 24-Week Study of OX219 Safety and Efficacy for Maintenance Treatment of Opioid Dependence". The purpose of this study was to assess safety, efficacy, and treatment retention following extended treatment with OX219, a higher-bioavailability buprenorphine/naloxone (BNX) sublingual tablet formulation in opioid-dependent patients who completed 1 of 2 primary efficacy and safety studies of OX21...
What is the current status of trial NCT01903005?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 668 participants. The study started on 2013-07. Estimated completion is 2014-09.
What interventions are being tested in trial NCT01903005?
The interventions under investigation include: Higher bioavailability BNX sublingual tablets (DRUG).
Who is sponsoring clinical trial NCT01903005?
This trial is sponsored by Orexo AB, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01903005's enrollment target sits among peer trials
668 120th of 2000 higher than 1,881 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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