NCT01903005

Multi-Center, Open-Label, 24-Week Study of OX219 Safety and Efficacy for Maintenance Treatment of Opioid Dependence

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 668 (actual)
• Sponsor: Orexo AB · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This was a multicenter, open-label, uncontrolled, single-arm, 24-week, extension study to assess safety, efficacy, and treatment retention during maintenance treatment. Eligible patients had completed 1 of 2 primary efficacy and safety studies of the higher-bioavailability BNX sublingual tablet formulation (primary study OX219-006 \[NCT01908842\] or OX219-007 \[NCT01848054\]). The total duration of study treatment was 24 weeks.

Conditions

• Opioid Dependence, on Agonist Therapy

Interventions

Type	Name	Description
DRUG	Higher bioavailability BNX sublingual tablets	Once daily, open-label treatment with higher bioavailability BNX sublingual tablets for 24 weeks

Timeline

• Start date: 2013-07-01
• Primary completion: 2014-09-01
• Completion: 2014-09-01
• First posted: 2013-07-19
• Last updated: 2015-10-28
• Results posted: 2015-10-28

Locations

28 sites across 1 country: United States