CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 668 enrolled
Drug / intervention
Higher bioavailability BNX sublingual tabletsdrug
Likely dose
Not stated in 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/NCT01903005
NCT01903005Phase 4Completed
CompareCT.gov

A Multi-center, Open-Label, 24-Week, Follow-Up Study to Assess Safety, Efficacy, and Treatment Adherence For Maintenance Treatment of Opioid Dependence With OX219

Orexo AB·interventional·Posted Jul 19, 2013·Updated Oct 28, 2015

In Brief

A Phase 4 clinical trial evaluating Higher bioavailability BNX sublingual tablets for Opioid Dependence, on Agonist Therapy. Completed, enrolled 668 participants across 28 sites.

Detailed Summary

The purpose of this study was to assess safety, efficacy, and treatment retention following extended treatment with OX219, a higher-bioavailability buprenorphine/naloxone (BNX) sublingual tablet formulation in opioid-dependent patients who completed 1 of 2 primary efficacy and safety studies of OX219.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOpioid Dependence, on Agonist Therapy
CountriesUnited States
CollaboratorsWorldwide Clinical Trials

Timeline

Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJul 19, 2013
Enrollment StartJul 1, 2013
Primary CompletionSep 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 13.0 years ago

Interventions

Higher bioavailability BNX sublingual tabletsdrug

Once daily, open-label treatment with higher bioavailability BNX sublingual tablets for 24 weeks