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
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Orexo AB
- 入组人数
- 668
- 主要终点
- Number of Patients Reporting Treatment-Emergent Adverse Events
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
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.
干预措施: Higher bioavailability BNX sublingual tablets (Drug)
结局指标
主要结局
Number of Patients Reporting Treatment-Emergent Adverse Events
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: Day 1 through week 24
Study discontinuations due to treatment-emergent adverse events that occurred during treatment with bioavailability BNX sublingual tablets
次要结局
- 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)