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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 is a Phase 4 study that has completed, run by Orexo AB. The registered enrollment target is 668 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01903005
The ClinicalTrials.gov registry entry for NCT01903005 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 668 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Orexo AB, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Higher bioavailability BNX sublingual tablets is the first listed.
NCT01903005 reports 0 study locations.
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.
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