CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 249 enrolled
Drug / intervention
BEMA Buprenorphine NX filmsdrug
Likely dose
BEMA Buprenorphine NX films 0.6 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01666119
NCT01666119Phase 2Completed
CompareCT.gov

An Open Label Study To Assess The Safety And Tolerability Of BEMA® Buprenorphine NX In Opioid Dependent Subjects (BNX-201)

BioDelivery Sciences International·interventional·Posted Aug 16, 2012·Updated Apr 4, 2017

In Brief

A Phase 2 clinical trial evaluating BEMA Buprenorphine NX films for Opioid Dependence. Completed, enrolled 249 participants across 10 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOpioid Dependence
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedAug 16, 2012
Enrollment StartAug 1, 2012
Primary CompletionJan 1, 2013
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 13.9 years ago

Interventions

BEMA Buprenorphine NX filmsdrug

BEMA Buprenorphine NX films (3.5/0.6 mg and 5.25/0.9 mg buprenorphine/naloxone) will be provided in 3.361 and 5.447 cm2 film sizes, respectively.