NCT00661063Unknown3 期
Diabetic Neuropathic Pain Topical Treatment- Comparative Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- pain evaluation by visual analogue scale
研究概览
简要总结
Comparative study of efficacy and safety of ketamine, clonidine, mixture of both and placebo in patients with diabetic neuropathic pain
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Diabetes Mellitus type I or II
- •Mono or polyneuropathy
- •Treatment with Tricyclic Antidepressant, Carbamazepine during 3 weeks at least
- •Preserved cognition
排除标准
- •Ulcerative or infection or vesicle lesion in pain site
- •Pregnancy
- •Breast feeding
研究组 & 干预措施
K
Experimental
drug - ketamine 1% gel
干预措施: ketamine (Drug)
P
Placebo Comparator
vehicle gel
干预措施: vehicle gel (Drug)
M
Experimental
association of ketamine and clonidine gel
干预措施: ketamine + clonidine (Drug)
C
Experimental
clonidine gel
干预措施: clonidine gel 1% (Drug)
结局指标
主要结局
pain evaluation by visual analogue scale
时间窗: 12 weeks
次要结局
- pain evaluation by amount of rescue medication required(12 weeks)
研究者
研究点 (1)
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