NCT00113620已完成3 期
A Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Safety and Efficacy of Dextromethorphan and Quinidine at Two Dose Levels in the Treatment of the Pain of Diabetic Neuropathy
Avanir Pharmaceuticals85 个研究点 分布在 1 个国家目标入组 450 人开始时间: 2005年7月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 450
- 试验地点
- 85
- 主要终点
- Pain rating scale obtained from patient diaries
研究概览
简要总结
The purpose of this study is to determine whether dextromethorphan (Neurodex) and quinidine are effective in the treatment of pain of diabetic neuropathy.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of diabetes mellitus
- •Established diabetic therapy for at least 3 months
- •Lab-supported diagnosis of painful diabetic distal symmetric sensory/motor polyneuropathy
- •Pain the previous three months
- •Not pregnant
排除标准
- •Patient failed adequate trial of 3 or more medications or has required narcotics for pain
- •History of torsades de pointes
- •Sensitivity to quinidine or opiate drugs (codeine, etc)
- •Severe pain that could confound the assessment
- •Patient has had any amputations
- •Patient has participated in the past 30 days or is currently participating in another trial
- •Patient has previously received treatment with dextromethorphan and quinidine
结局指标
主要结局
Pain rating scale obtained from patient diaries
次要结局
- Additional diary rating scales and scores obtained from clinic visits
研究者
研究点 (85)
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