An Open-label, Single Centre Prospective Cohort Study to Determine the Effectiveness and Safety of Targin® for Pain Management and Opioid-induced Constipation in Patients With Spinal Cord Injury: Can we Improve Pain and Ameliorate Secondary Complications of Opioid Treatment?
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Change in management of pain related to spinal cord injury
研究概览
简要总结
The study will be investigating the effectiveness of oxycodone-naloxone (brand name Targin®) at treating chronic pain in individuals with spinal cord injury. The goal of the study is to compare the effectiveness of Targin® at treating chronic pain in individuals with sub-acute and chronic spinal cord injury compared to opioid medication that is not compounded with naloxone.
详细描述
This is a Phase 4, open-label prospective cohort study investigating Targin® for treating chronic pain in individuals with sub-acute and chronic spinal cord injuries. Targin® is currently approved for use by Health Canada for the treatment of moderate-to-severe chronic pain and will be investigated here for the management of moderate-to-severe chronic pain following spinal cord injury. The effectiveness and safety of opioid use for individuals with spinal cord injury has yet to be thoroughly investigated. Additionally, individuals with spinal cord injury using opioids may have the superimposed effect of neurogenic bowel and opioid induced constipation, which may cause increased frequency and severity of autonomic dysreflexia episodes, reduced quality of life, depressive symptoms, and discontinuation of opioid medication. Targin® has the potential to ameliorate these symptoms and improve treatment adherence in individuals with spinal cord injury.
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
Oxycodone Naloxone Combination
Open-Label
干预措施: Oxycodone Naloxone Combination (Drug)
结局指标
主要结局
Change in management of pain related to spinal cord injury
时间窗: 8 weeks
Evaluation and assessment of pain is the primary objective. The evaluation tool "Revised McGill Short Form Pain" Questionnaire (SF-MPQ-2) is one of the most frequently used measures in clinical and research contexts to evaluate pain. The primary outcome measure is a change from baseline in SF-MPQ-2 score at 8 weeks.
次要结局
- Change from Baseline in management of neurogenic bowel and opioid induced constipation(8 weeks)
- Change from Baseline of autonomic function.(8 weeks)
- Change from Baseline of quality of life.(8 weeks)
- Change from Baseline in depressive symptoms.(8 weeks)
- Change from baseline of opioid side effect cognitive function.(8 weeks)
- Change from Baseline in total daily dose of medications to manage pain related to spinal cord injury(8 weeks)
- Change from baseline of opioid side effects.(8 weeks)
- Change from Baseline in total daily dose of medications to manage bowel routine(8 weeks)
研究者
Andrei Krassioukov
Principal Investigator
University of British Columbia