Randomized Phase II Trial Evaluating Activity and Tolerability of Fixed Dose of Oxycodone and Increasing Dose of Pregabalin Versus Increasing Dose of Oxycodone and Fixed Dose of Pregabalin for the Treatment of Oncological Neuropathic Pain
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 7
- 主要终点
- Achievement of analgesia (decrease of at least 1/3 of pain intensity) assessed by NRS scale
研究概览
简要总结
The aim of the study is to assess tolerability and activity of oxycodone and pregabalin in combination for the treatment of oncological neuropathic pain with two different strategies.
详细描述
Neuropathic pain is frequently diagnosed as a complication of cancer pain. While opioids are the mainstay of cancer pain management,their efficacy in neuropathic pain seems to be less then optimal,and adjuvant drugs, mainly anticonvulsants and antidepressants,are often combined with opioids in the analgesic regimen of patients with neuropathic cancer pain. This approach is suggested by well-established guidelines, but the analgesic benefit and the safety of pregabalin and oxycodone in combination is not yet documented.
The aim of this study is to assess the activity and tolerability of the addition of pregabalin to oxycodone in the treatment of patients with neuropathic pain due to neoplasm.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •instrumental and clinical diagnosis of every malignant neoplasm
- •presence of pain with a neuropathic component in the opinion of the physician
- •presence of pain >=4(NRS)
- •PS ECOG <3
- •written informed consent
排除标准
- •serum creatinine >2mg/ml or creatinine clearance <40 ml/min
- •mild or severe hepatic insufficiency
- •iatrogenic neuropathy caused by chemotherapeutic agents
- •previous allergic reactions to oxycodone and pregabalin
- •pregnancy or breastfeeding
研究组 & 干预措施
A
oxycodone 20 mg/day plus pregabalin at increasing dose starting from 50 mg/day for 15 days or until unacceptable toxicity develops
干预措施: pregabalin (Drug)
B
pregabalin 50 mg/day plus oxycodone at increasing dose starting from 20 mg/day. For 15 days or until unacceptable toxicity develops
干预措施: pregabalin (Drug)
B
pregabalin 50 mg/day plus oxycodone at increasing dose starting from 20 mg/day. For 15 days or until unacceptable toxicity develops
干预措施: oxycodone (Drug)
A
oxycodone 20 mg/day plus pregabalin at increasing dose starting from 50 mg/day for 15 days or until unacceptable toxicity develops
干预措施: oxycodone (Drug)
结局指标
主要结局
Achievement of analgesia (decrease of at least 1/3 of pain intensity) assessed by NRS scale
时间窗: within 15 days
次要结局
- Pain control rate(within 15 days)
- Reduction of Break Through Pain number(within 15 days)
- Record of adverse events(within 15 days)
- Reduction of allodynia in patients presenting it at T0(within 15 days)
- Patient satisfaction(within 15 days)
- Assessing whether COMT and mu blood polymorphisms are associated to response(within 15 days)