NCT00258622已完成2 期
NS1209 and Lidocaine in Patients With Peripheral Neuropathic Pain: a Randomized, Double-Blind, Placebo-Controlled, Crossover Study
Danish Pain Research Center2 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2005年11月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- - Spontaneous ongoing pain intensity (VAS 0-100)
研究概览
简要总结
Purpose: To evaluate the efficacy, tolerability and safety of NS1209 compared to lidocaine and placebo in patients with peripheral chronic neuropathic 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
- •Age >18 years
- •Neuropathic pain and allodynia after a peripheral nerve injury (VAS >= 4)
排除标准
- •Patients who cannot cooperate and do no understand Danish
- •Fertile women
- •Clinically significant abnormality or disease
- •Drug and alcohol abuse
- •Clinically abnormal ECG
- •Hypersensitivity to any of the treatments
- •Patients in treatment with cimetedin, antidepressants, antipsychotics, antiepileptics except gabapentin, anticoagulants, Na channel blockers and beta blockers
- •Patients who have previously been treated in a NS1209 study
- •Patients treated with an investigational drug
结局指标
主要结局
- Spontaneous ongoing pain intensity (VAS 0-100)
次要结局
- Number of responders (at least 33% pain reduction)
- Effect on evoked allodynia (VAS 0-100)
- Pain relief for overall spontaneous pain (complete, good, moderate, slight, none or worse)
- Feeling of unpleasantness (VAS 0-100)
- Pain on movements (VAS 0-100)
- Daily pain (NSP 0-10)
研究者
研究点 (2)
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