NCT01106716已完成2 期
A Double-Blind, Randomized, Placebo- and Active-Comparator-Controlled, Single-Dose Study to Assess the Efficacy of KAI-1678 Administered by Subcutaneous Infusion in Subjects With Postherpetic Neuralgia
KAI Pharmaceuticals0 个研究点目标入组 23 人开始时间: 2009年3月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 主要终点
- The effect of KAI-1678 on mean change from baseline in pain intensity at 6 hours (PID 6).
研究概览
简要总结
The purpose of this study is to determine whether KAI-1678 is effective in the treatment of postherpetic neuralgia pain
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •diagnosis of PHN with pain for at least 3 months after segmental herpes zoster eruption
- •pain score at least 4 on 11-point numerical rating scale (0-10)
- •stable doses of analgesic medications for at least 1 month"
排除标准
- •diagnosis of PHN with pain for at least 3 months after segmental herpes zoster eruption
- •pain score at least 4 on 11-point numerical rating scale (0-10)
- •stable doses of analgesic medications for at least 1 month"
研究组 & 干预措施
A1: Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
A2: KAI-1678
Experimental
Experimental
干预措施: KAI-1678 (Drug)
A3: Lidocaine
Active Comparator
Lidocaine
干预措施: Lidocaine (Drug)
结局指标
主要结局
The effect of KAI-1678 on mean change from baseline in pain intensity at 6 hours (PID 6).
时间窗: Day 1
Measurements are made using a qualified pain scale and the change from basline is calculated at 6 hours.
次要结局
- The effect of KAI-1678 on the proportion of subjects achieving at least a 1 point improvement in pain intensity at 6 hours(Day 1)
- The effect of KAI-1678 on patient global response to treatment(Day 1)
- The effect of KAI-1678 on symptoms associated with PHN assessed by the Neuropathic Pain Scale (NPS)(Day 1)
- The number of adverse events as a measure of safety and tolerability of KAI-1678(Two weeks)
研究者
相似试验
已完成
2 期
Safety and Efficacy Study of KAI-1678 to Treat Subjects With Postoperative PainPain, PostoperativeNCT01015235KAI Pharmaceuticals90
已完成
2 期
Safety and Efficacy Study of KAI-1678 to Treat Pain in Subjects With Spinal Cord InjurySpinal Cord InjuryNCT01135108KAI Pharmaceuticals5
已完成
2 期
A Phase 2 Clinical Study of KHK4827Moderate to Severe Plaque PsoriasisNCT01748539Kyowa Kirin Co., Ltd.140
已完成
2 期
A Comparative Study of KHK6188Postherpetic NeuralgiaNCT01544296Kyowa Kirin Co., Ltd.42
未知
2 期
Phase II study of KHK6188Postherpetic neuralgiaJPRN-jRCT2080221716Kyowa Hakko Kirin Co., Ltd.42