NCT00380913已完成4 期
A Multicenter Trial Evaluating the Efficacy of Cesamet™ for the Symptomatic Treatment of Pain in Patients With Diabetic Peripheral Neuropathy
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 8
- 主要终点
- The Average Pain Score at target site.
研究概览
简要总结
This study was designed to evaluate the safety and efficacy of Cesamet™ in controlling pain in subjects experiencing pain due to diabetic peripheral neuropathy.
详细描述
The purpose of this study is to determine the safety and efficacy of Cesamet™ in the symptomatic treatment of pain due to diabetic peripheral neuropathy.
This is a phase IV, multi-center, open label outpatient clinical trial evaluating Cesamet™ treatment for control of pain due diabetic peripheral neuropathy. The study has two phases: a Pretreatment Phase and a Treatment Phase.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with diabetic peripheral neuropathic pain
- •Chronic daily pain present for at least 2 months
- •On stable analgesic regimen for one month
- •Baseline pain score greater than 40mm on a visual analog scale
排除标准
- •Hypersensitivity to compounds in study drug or similar drugs
- •Pregnant or lactating females
- •Drug or alcohol abuse
- •Unstable medical condition
结局指标
主要结局
The Average Pain Score at target site.
次要结局
- The Worst Pain Score at target site.
- The Pain at Night Score at target site.
- Quality of Life measures
- Patient satisfaction with treatment
- Safety will be assessed through the collection of AEs and vital signs.
研究者
研究点 (8)
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