Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 3 study, sponsored by Orexo AB.
NCT01908842 is a Phase 3 study that has completed, run by Orexo AB. The registered enrollment target is 759 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Retention rates (number of patients retained) for the primary efficacy endpoints of retention in treatment at Days 3 and 15, which was defined as the number of patients who received treatment on Days 3 and 15.
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 |
What the finished NCT01908842 record still lists
NCT01908842 is an interventional study that assigns participants to a tested intervention. The registered 759 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which Buprenorphine is the first listed.
NCT01908842 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01908842's enrollment target sits among peer trials
759 455th of 2000 higher than 1,545 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02089607 · 760 participants · NA
CAAAs, TAAAs, Aortic Arch Aneurysms or Dissections With Fenestrated/Branched Stent Graft
- NCT04073706 · 760 participants · Phase 3
Sentinel Node Biopsy in Endometrial Cancer
- NCT05129228 · 760 participants · NA
Optical Coherence Tomography of the Saphenous Vein Graft
- NCT05787821 · 760 participants
Persona OsseoTi Keel Compatibility Study (Total Knee Arthroplasty)
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia