NCT00143442已完成2 期
A 5-Week, Randomized, Double-Blind, Placebo-Controlled Multi-Center Study Of [S,S]-Reboxetine In Patients With Postherpetic Neuralgia (PHN), Who Are Gabapentin Treatment Failures.
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
- 184
- 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 5 will be calculated.
研究概览
简要总结
The purpose of this study is to determine the effectiveness of [S,S]-Reboxetine in the treatment of chronic pain following a shingles infection in patients who are Gabapentin treatment failures.
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 > or = 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
The numerical pain intensity rating scale is used to assess pain and a change from baseline in pain score for week 5 will be calculated.
次要结局
- - The mean endpoint (week 5) sleep interference score change from baseline - Analysis of the Patient Global Impression of Change - Analysis of the Clinical Global Impression of Change - Analysis of the SF-McGill questionnaire
研究者
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