NCT00380965已完成4 期
A Multicenter Trial Evaluating the Safety and Efficacy of Cesamet™ for the Symptomatic Treatment of Chemotherapy-Induced Neuropathic Pain in Patients With Cancer
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
- 4
- 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 chemotherapy-induced neuropathic pain in patients with cancer.
详细描述
To determine the safety and efficacy of Cesamet™ in the symptomatic treatment of chemotherapy-induced neuropathic pain.
This is a phase IV, multicenter, open label of Cesamet™ at 1 mg daily progressing to 2mg BID in subjects with chemotherapy-induced neuropathic pain. This 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 diagnosed with chemotherapy-induced 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 VAS.
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 Pain at Night Score at target site.
- Patient satisfaction with treatment.
- Safety will be assessed through the collection of AEs and vital signs.
- The Worst Pain Score at target site.
- Quality of Life measures.
研究者
研究点 (4)
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