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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 is a Phase 2 study that has completed, run by BioDelivery Sciences International. The registered enrollment target is 249 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01666119
The ClinicalTrials.gov registry entry for NCT01666119 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 249 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is BioDelivery Sciences International, which has 17 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which BEMA Buprenorphine NX films is the first listed.
NCT01666119 reports 0 study locations.
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.
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