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临床试验/NCT00159666
NCT00159666已完成4 期

A Double-Blind Randomized Placebo-Controlled Trial of the Time to Onset of Pain Relief in Subjects With Post Therapeutic Neuralgia (PHN) Treated With Pregabalin (150 - 600 Mg/Day Flexible Optimized Dose or 300 Mg/Day Fixed Dose) or Placebo

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.40 个研究点 分布在 5 个国家目标入组 255 人开始时间: 2004年10月1日最近更新:
适应症
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
255
试验地点
40
主要终点
Onset meaningful pain reduction

研究概览

简要总结

The purpose of this study is to measure how rapidly pregabalin treatment can relieve pain in patients with post-herpetic neuralgia

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
Double

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of PHN with pain present for at least three months after the healing of a Herpes Zoster skin lesion.
  • Subjects must have completed the Daily Pain Rating Scale in the electronic diary at least 4 times during screening and have an average daily pain rating score of greater than or equl to 4 during the 7 +/- 3 days prior to randomization (Visit 2).

排除标准

  • History of neurolytic or neurosurgical therapy for PHN.
  • Presence of any severe pain associated with conditions other than PHN that may confound the assessment or self-evaluation of the pain due to PHN.

结局指标

主要结局

Onset meaningful pain reduction

次要结局

未报告次要终点

研究者

发起方
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
申办方类型
Industry

研究点 (40)

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