NCT01135108已完成2 期
A Double-Blind, Randomized, Placebo-Controlled, Single-Dose Two-Period Crossover Study to Assess the Efficacy of KAI-1678 Administered by Subcutaneous Infusion in Subjects With Spinal Cord Injury
KAI Pharmaceuticals0 个研究点目标入组 5 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
- 5
- 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 pain associated with spinal cord injury.
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
- •spinal cord injury at least 1 year prior and nonprogressive ofr at least 6 months
- •central neuropathic pain for at least 3 months or with relapses and remissions for at least 6 months
- •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
- •history of chronic alcoholism or chronic substance abuse
- •tolerance to opioid analgesics
- •clinically significant abnormality on laboratory tests or ECG
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)
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: 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(6 hours)
- The effect of KAI-1678 on patient global impression of change(6 hours)
- The effect of KAI-1678 on symptoms of neuropathic pain assessed by the Neuropathic Pain Scale (NPS)(6 hours)
- The number of participants with adverse events as a measure of safety and tolerability of KAI-1678(Two weeks)
研究者
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