NCT00334685终止2 期
[S,S]-Reboxetine Add-On Trial: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Trial Of [S,S]-Reboxetine In Patients With Postherpetic Neuralgia (PHN) Concomitantly Treated With Pregabalin.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 136
- 试验地点
- 1
- 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 10 will be calculated
研究概览
简要总结
The purpose of this study is to determine the effectiveness of adjunctive treatment of pregabalin with [S,S]-Reboxetine against pregabalin monotherapy in patients with PHN
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 (Participant, Investigator)
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 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
研究组 & 干预措施
[S,S]-Reboxetine + Pregabalin
Experimental
干预措施: [S,S]-Reboxetine + Pregabalin (Drug)
Pregabalin
Active Comparator
干预措施: Pregabalin (Drug)
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 10 will be calculated
时间窗: Week 10
次要结局
- The mean endpoint (week 10) sleep interference score change from baseline(Week 10)
- Analysis of the Medical Outcomes Study Sleep Scale(Week 10)
- Analysis of the Patient Global Impression of Change(Week 10)
- Analysis of the Neuropathic Pain Symptom Inventory(Week 10)
研究者
研究点 (1)
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