跳至主要内容
临床试验/NCT00159640
NCT00159640终止2 期

A Multi-Center, Randomized, Double Blind, Dose-Response, Placebo And Gabapentin Controlled Study Of PD-217,014 In The Treatment Of Postherpetic Neuralgia

Pfizer32 个研究点 分布在 6 个国家目标入组 315 人开始时间: 2004年2月1日最近更新:
适应症
相关药物

试验速览

阶段
2 期
状态
终止
发起方
Pfizer
入组人数
315
试验地点
32
主要终点
To characterise the effectiveness of PD-217,014 in the treatment of chronic pain. A numerical pain intensity rating scale is used to assess pain and a mean endpoint (week 4) pain score change from baseline is calculated.

研究概览

简要总结

The purpose of this study is to determine the effectiveness of PD-217,014 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
否

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 poor renal function.
  • •Patients with other severe pain, that may impair the self-assessment of the pain due to shingles.
  • •Patients with abnormal electrocardiogram.

结局指标

主要结局

To characterise the effectiveness of PD-217,014 in the treatment of chronic pain. A numerical pain intensity rating scale is used to assess pain and a mean endpoint (week 4) pain score change from baseline is calculated.

次要结局

  • - Assess the effect of PD-217,014 on responder rate based on the primary endpoint, mean endpoint sleep interference score and the SF-McGill questionnaire (change from baseline to week 4)

研究者

发起方
Pfizer
申办方类型
Industry

研究点 (32)

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