NCT02687347Unknown3 期
A Double Blind Randomized Clinical Trial to Investigate the Efficacy and Safety of Ultra-low Dose Methadone as Adjuvant Analgesic Therapy in Cancer Patients With Pain
McGill University Health Centre/Research Institute of the McGill University Health Centre1 个研究点 分布在 1 个国家目标入组 204 人开始时间: 2016年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 204
- 试验地点
- 1
- 主要终点
- pain relief
研究概览
简要总结
The research hypothesis of this study is: In patients with moderate to severe cancer related pain, the addition of low dose methadone to an existing opioid significantly reduces pain severity compared to low doses morphine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed of cancer-related pain of more than 3 months duration
- •Pain relief during the last week rated unsatisfactory by the patient
- •Pain severity during the last week rated moderate (between 4 and 7/10)
- •Analgesic therapy must have been stable for 7 days
- •Able to understand English or French
- •Willing and able to give written informed consent
排除标准
- •Patients who are currently receiving or have received methadone as analgesic in the last 6 months
- •Contraindication to receive methadone (allergy, QTc segment on the ECG>450msec, concurrent treatment with medication that could increase methadone's effects)
- •Patients presenting with changes in their cancer status/treatment with potential effects on their pain severity, during the duration of the trial (eg: new metastasis, indication for radiotherapy)
- •Patients whose life expectancy is shorter than 2 months
- •Patients with cognitive impairment presenting with difficulties understanding the trial and completing the research questionnaires
- •Pregnant or lactating women (women of childbearing potential must have negative pregnancy test)
研究组 & 干预措施
study arm
Experimental
low dose methadone (1-10mg daily)
干预措施: oral methadone (Drug)
control arm
Active Comparator
low dose morphine (1-10 mg/day)
干预措施: oral morphine (Drug)
结局指标
主要结局
pain relief
时间窗: 2 months
Questions 3 to 6 of the Brief Pain Inventory
次要结局
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0".(2 months)
研究者
Jordi Perez
Codirector Cancer Pain Program. McGill University Health Centre. Montreal, Canada
McGill University Health Centre/Research Institute of the McGill University Health Centre
研究点 (1)
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