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

Opioid Dependence, on Agonist Therapy Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Opioid Dependence, on Agonist Therapy
• Opioid-Related Disorders

• NCT number: NCT01903005
• Study type: Interventional
• Source: Orexo AB
• Status: Completed
• Phase: Phase 4
• Start date: July 2013
• Completion date: September 2014