NCT01326689已完成3 期
Phase III Study of KW-2246 (A Double Blind Study of KW-2246 Compared to Placebo for Breakthrough Pain Episodes in Cancer Patients)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 42
- 主要终点
- Pain intensity difference
研究概览
简要总结
This is a placebo-controlled, double blind, comparative study to evaluate the efficacy and safety of KW-2246 as rescue medication at an optimal dose, which is determined by dose titration in treating breakthrough pain episodes in adult cancer patients receiving strong opioid analgesic on a fixed-schedule as well as rescue medication for breakthrough 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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •Have been treated with opioid analgesic on a fixed-schedule at a stable daily dose
- •Receiving at least 1 but not more than 4 doses of rescue medication per day in average and whose pain is controlled
- •ECOG PS =< 3
排除标准
- •Currently suffered from intolerable opioid-specific adverse reactions due to opioid analgesics
- •Severe respiratory dysfunction
- •Severe bradyarrhythmia
- •Severe hepatic function disorder
- •Severe renal function disorder
- •Severe psychoneurotic disorder
- •Susceptibility to respiratory depression due to such conditions as increased intracranial pressure, head injury or brain tumor
研究组 & 干预措施
KW-2246
Experimental
干预措施: KW-2246 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Pain intensity difference
时间窗: 30 minutes after each dose
Pain scores on the visual analog scale
次要结局
未报告次要终点
研究者
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未知
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