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NCT01908842 · ClinicalTrials.gov registry record · Phase 3
Efficacy of BNX Sublingual Tablets Versus BNX Sublingual Film for Treatment of Opioid-Dependent Adults
A Phase 3 study, sponsored by Orexo AB.
- Completed
- Registry status
- Phase 3
- Development phase
- 759
- Enrollment target
NCT01908842 is a Phase 3 study that has completed, run by Orexo AB. The registered enrollment target is 759 participants.
The verdict
NCT01908842, a Phase 3 study, has completed, sponsored by Orexo AB.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 759 participants
- Enrollment target
Study Summary
The purpose of this study was to assess retention in treatment after induction with buprenorphine/naloxone (BNX) sublingual tablets compared with generic buprenorphine and after stabilization with BNX sublingual tablets compared with BNX film. Secondary objectives included assessment of treatment effects on opioid withdrawal symptoms, opioid cravings, and safety.
Interventions
- DRUG Buprenorphine
- DRUG BNX sublingual tablets
- DRUG BNX sublingual film
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 759 participants |
| Start Date | 2013-08 |
| Est. Completion | 2014-04 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01908842
The ClinicalTrials.gov registry entry for NCT01908842 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 759 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 3 interventions - of which Buprenorphine is the first listed.
NCT01908842 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01908842 about?
NCT01908842 is a clinical study titled "Efficacy of BNX Sublingual Tablets Versus BNX Sublingual Film for Treatment of Opioid-Dependent Adults". The purpose of this study was to assess retention in treatment after induction with buprenorphine/naloxone (BNX) sublingual tablets compared with generic buprenorphine and after stabilization with BNX sublingual tablets compared with BNX film. Secondary objectives included assessment of treatment ef...
What is the current status of trial NCT01908842?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 759 participants. The study started on 2013-08. Estimated completion is 2014-04.
What interventions are being tested in trial NCT01908842?
The interventions under investigation include: Buprenorphine (DRUG), BNX sublingual tablets (DRUG), BNX sublingual film (DRUG).
Who is sponsoring clinical trial NCT01908842?
This trial is sponsored by Orexo AB, which has 4 total clinical trials registered on ClinicalTrials.gov.
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