NCT00492388终止3 期
A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study Comparing the Efficacy and Safety of PMI-150 (Intranasal Ketamine) to Placebo as an Analgesic for the Treatment of Breakthrough Pain in Cancer Patients
Hospira, now a wholly owned subsidiary of Pfizer1 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2007年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- pain intensity difference
研究概览
简要总结
To assess the safety and efficacy of PMI-150 (Intranasal Ketamine) as an analgesic for the treatment of breakthrough pain in cancer patients.
详细描述
The primary objective is to evaluate the safety and efficacy following the administration of intranasal ketamine in providing pain relief as compared to placebo.
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
- 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
- •at least 18 years of age
- •Patients requiring around-the-clock opioids for pain due to cancer and with a history of experiencing episodes of breakthrough pain
排除标准
- •under 18 years
- •non-cancer pain
- •allergy to ketamine
研究组 & 干预措施
B
Placebo Comparator
placebo
干预措施: placebo (Drug)
A
Experimental
PMI-150 (intranasal ketamine)
干预措施: PMI-150 (intranasal ketamine) (Drug)
结局指标
主要结局
pain intensity difference
时间窗: 60 minutes
次要结局
- various pain assessments(60 minutes)
研究者
研究点 (1)
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