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NCT01666119 · ClinicalTrials.gov registry record · Phase 2
An Open Label Study To Assess The Safety And Tolerability Of BEMA® Buprenorphine NX In Opioid Dependent Subjects
A Phase 2 study, sponsored by BioDelivery Sciences International.
- Completed
- Registry status
- Phase 2
- Development phase
- 249
- Enrollment target
NCT01666119: Completed Phase 2 study, sponsored by BioDelivery Sciences International.
NCT01666119 is a Phase 2 study that has completed, run by BioDelivery Sciences International. The registered enrollment target is 249 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (87% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01666119, a Phase 2 study, has completed, sponsored by BioDelivery Sciences International.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 249 participants
- Enrollment target
Study Summary
This is an open label study in opioid dependent subjects maintained on a stabilized dose of Suboxone tablets or films. The purpose is to assess the safety and tolerability of BEMA Buprenorphine NX administered once daily for 12 weeks to opioid dependent subjects stabilized on Suboxone (buprenorphine/naloxone) tablets or films. Eligible subjects will be converted to an approximately equal dose of BEMA Buprenorphine NX. This dose will be taken throughout the 12-week treatment period with dose adjustments as clinically indicated for either the control of opioid dependence or adverse events (AEs).
Primary Outcome
Adverse events that occur in more than 2 subjects. Among the adverse events that occurred in \> 2 subjects, the total number of unique events that were experienced are reported.
Interventions
- DRUG BEMA Buprenorphine NX films
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 249 participants |
| Start Date | 2012-08 |
| Est. Completion | 2013-01 |
| Phase | Phase 2 |
What the finished NCT01666119 record still lists
NCT01666119 is an interventional study that assigns participants to a tested intervention. The registered 249 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (87% higher).
The record links to 0 conditions, and to 1 intervention - of which BEMA Buprenorphine NX films is the first listed.
NCT01666119 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01666119 about?
NCT01666119 is a clinical study titled "An Open Label Study To Assess The Safety And Tolerability Of BEMA® Buprenorphine NX In Opioid Dependent Subjects". This is an open label study in opioid dependent subjects maintained on a stabilized dose of Suboxone tablets or films. The purpose is to assess the safety and tolerability of BEMA Buprenorphine NX administered once daily for 12 weeks to opioid dependent subjects stabilized on Suboxone (buprenorphine...
What is the current status of trial NCT01666119?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 249 participants. The study started on 2012-08. Estimated completion is 2013-01.
What interventions are being tested in trial NCT01666119?
The interventions under investigation include: BEMA Buprenorphine NX films (DRUG).
Who is sponsoring clinical trial NCT01666119?
This trial is sponsored by BioDelivery Sciences International, which has 17 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01666119's enrollment target sits among peer trials
249 233rd of 2000 higher than 1,767 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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