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
Overview
- Phase
- Phase 4
- Intervention
- Higher bioavailability BNX sublingual tablets
- Conditions
- Opioid Dependence, on Agonist Therapy
- Sponsor
- Orexo AB
- Enrollment
- 668
- Primary Endpoint
- Number of Patients Reporting Treatment-Emergent Adverse Events
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Open-label BNX sublingual tablets
Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging from 5.7/1.4 mg to 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.
Intervention: Higher bioavailability BNX sublingual tablets
Outcomes
Primary Outcomes
Number of Patients Reporting Treatment-Emergent Adverse Events
Time Frame: Day 1 through week 24
Number of patients reporting treatment-emergent adverse events during open-label, extension treatment with higher bioavailability BNX sublingual tablets
Number of Patients Reporting Treatment-Related, Treatment-Emergent Adverse Events
Time Frame: Day 1 through week 24
Treatment-emergent adverse events considered related to treatment with the higher bioavailability BNX sublingual tablets
Number of Patients Reporting Treatment-Emergent Serious Adverse Events
Time Frame: Day 1 throught week 24
Patients reporting treatment-emergent serious adverse events considered either related or not related to treatment with the higher bioavailability BNX sublingual tablets
Number of Patient Discontinuations Due to Treatment-Emergent Adverse Events
Time Frame: Day 1 through week 24
Study discontinuations due to treatment-emergent adverse events that occurred during treatment with bioavailability BNX sublingual tablets
Secondary Outcomes
- Retention in Treatment in the Safety Population(Treatment retention was assessed at weeks 4, 8, 12, 16, 20, and 24)
- Mean Change From Primary Study Baseline (OX219-006 or OX219-007) in Clinical Opioid Withdrawal Scale (COWS) Score(Prior to dosing on day 1, at weeks 4, 8,12,16, 20, 24, and at study endpoint)
- Mean Change From Primary Study Baseline (OX219-006 or OX219-007) in Subjective Opioid Withdrawal Scale (SOWS) Score(Prior to dosing on day 1, at weeks 4, 8,12,16, 20, and 24, and at study endpoint)
- Mean Change From Primary Study Baseline (OX219-006 and OX219-007) in Visual Analog Scale (VAS) Craving Scores(Prior to dosing on day 1, at weeks 4, 8, 12, 16, 20, and 24, and at study endpoint)
- Percent Change From Primary Study Baseline (OX219-006 or OX219-007) for Question 1 of the Work Productivity/Activity Impairment: 6-Question Specific Health Problem Questionnaire (WPAI:SHP)(Study Endpoint)
- Mean Change From Primary Study Baseline (OX219-006 or OX219-007) for Questions 2-4 of the WPAI:SHP(Week 24)
- Mean Change From Primary Study Baseline (OX219-006 or OX219-007) for Questions 5-6 of the WPAI:SHP(Week 24)