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临床试验/NCT00288652
NCT00288652已完成2 期

[S,S]-Reboxetine Dose-Range Finding Trial: A 16-Week, Randomized, Double-Blind, Placebo And An Active Comparator Controlled, Multi-Center Trial Of [S,S]-Reboxetine In Patients With Postherpetic Neuralgia (PHN)

Pfizer79 个研究点 分布在 1 个国家目标入组 280 人开始时间: 2006年3月最近更新:
适应症
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
Pfizer
入组人数
280
试验地点
79
主要终点
The numerical pain intensity rating scale is used to assess pain and a change from baseline in pain score for week 14 will be calculated

研究概览

简要总结

The purpose of this study is to determine the effectiveness of different doses of [S,S]-Reboxetine in the treatment of chronic pain following a shingles infection

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

  • Patients must have pain present for more than 3 months after the healing of shingles skin rash
  • Patients at screening must have a score >/=40 mm on the pain visual analogue scale

排除标准

  • Patients with significant renal and hepatic impairment
  • Patients with other severe pain, that may impair the self-assessment of the pain due to shingles
  • Patients with clinically abnormal electrocardiogram

结局指标

主要结局

The numerical pain intensity rating scale is used to assess pain and a change from baseline in pain score for week 14 will be calculated

次要结局

  • - The mean endpoint (week 14) sleep interference score change from baseline - Analysis of the Medical Outcomes Study Sleep Scale - Analysis of the Patient Global Impression of Change - Analysis of the SF-36 Health Survey

研究者

发起方
Pfizer
申办方类型
Industry

研究点 (79)

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