Oxcarbazepine for the Treatment of Chronic Peripheral Neuropathic Pain: Predictors of Response - a Randomised, Double-blind, Placebo-controlled Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 117
- 试验地点
- 2
- 主要终点
- Total pain rated on numeric rating scale
研究概览
简要总结
The purpose of this trial is to determine if the effect of oxcarbazepine on chronic peripheral nerve pain depends on the supposed mechanism of the pain, ie. if oxcarbazepine mainly relieve pain in patients with irritable nerves.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •age > 18 years old
- •definite or probable neuropathic pain
- •diagnosis of polyneuropathy, postherpetic neuralgia or peripheral nerve inju
- •pain duration > 3 months
- •pain rating at baseline >= 4 point NRS
- •Informed consent
排除标准
- •other non-neuropathic pain condition
- •allergy to oxcarbazepine
- •renal or hepatic impairment
- •depression and other serious psychiatric disorders
- •serious medical condition
- •previous treatment for neuropathic that cannot be stopped
- •pregnancy
- •patients expected not to be able to comply with study protocol
- •treatment with anticonvulsants, antidepressant or opioids
研究组 & 干预措施
oxcarbazepine
Oxcarbazepine is gradually increased during 21 days from 300 mg x 1 daily to 2400 mg, and kept on that dose ( 2400 mg) for three weeks.
干预措施: Oxcarbazepine (Drug)
placebo
干预措施: Oxcarbazepine (Drug)
结局指标
主要结局
Total pain rated on numeric rating scale
时间窗: Measurements from week 6 of treatment period
Pain is rated daily on 0-10 point numeric rating scales. From the daily ratings from week 6 of each treatment period a median value is determined and used for data analysis. The analysis will compare scores between treatments (oxcabazepine vs placebo) and treatment effects (placebo-oxcarbazepine) between groups irritable nociceptor vs non-irritable nociceptors and some other subgroups.
次要结局
- Response defined as at least 50% reduction in pain score(Week 6 of each treatment period vs. baseline)
- Neuropathic Pain Symptom Inventory(Week 6 of each treatment period)
- Patient Global Impression of Change(Week 6 of each treatment period)
- Rating of evoked pain(Week 6 of each treatment period)
- Sleep disturbance(Week 6 of each treatment period)
- Quality of life(Week 6 of each treatment period)
- Use of escape medication(Week 6 of each treatment period)
研究者
Søren H. Sindrup
Professor
Odense University Hospital