Prevention Effect of Pregabalin on Postherpetic Neuralgia: A Multicenter, Randomized, Double-blind, Controlled Trial
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 342
- 试验地点
- 1
- 主要终点
- the changes of numerical rating scale (NRS)
研究概览
简要总结
Pregabalin is effective on herpetic neuralgia, but whether can prevention post-herpetic neuralgia still need to confirm.
详细描述
Pregabalin has been recommended as the first-line drug for post-herpetic neuralgia (PHN) therapy currently due to its efficacy and safety. However,there was no valuable report at present on the clinical efficacy of pregabalin for acute and subacute herpetic neuralgia (SHN), expect for a smaller study which included 29 outpatients who had acute zoster pain for a period of 7-1 4 days. And it is not clear whether early application of pregabalin can reduce the incidence of PHN.
Therefore, this study was rational designed to evaluate the efficacy and safety of pregabalin in the treatment of herpetic neuralgia，and follow-up to the 8 months, evaluation whether impacting the accidence of PHN.
It is the first time in the international that treating acute herpetic neuralgia (AHN) and SHN with pregabalin as a large sample size clinical trial. The results of this study will be great significance for guiding the clinical medication.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pain occurs within 90 days of rash onset
- •Numerical rating scale (NRS) greater than 50 mm
排除标准
- •Patient with nervous system disorders which impair completing the pain diaries
- •Patient with history of illicit drug or alcohol abuse within the last 2 years
研究组 & 干预措施
pregabalin
experiment group: pregabalin 300mg,q12h for 6 months
干预措施: Pregabalin (Drug)
gabapentin
compared to pregabalin effect on herpetic neuralgia
干预措施: Gabapentin (Drug)
结局指标
主要结局
the changes of numerical rating scale (NRS)
时间窗: from the date of start to 8 month
Pain intensity was rated on an 1 1-point numerical rating scale
次要结局
- Brief Pain Inventory (BPI)(baseline and 8th month)