NCT00709436已完成3 期
Randomized, Multiple-center, Double-blind, Placebo-controlled Study of the Safety and Analgesic Efficacy of Repeated Dosing of PMI-150 (Intranasal Ketamine) to Treat Acute Post-operative Pain Following Orthopedic Trauma, Injury, or Surgery.
Hospira, now a wholly owned subsidiary of Pfizer16 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2008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
- 已完成
- 发起方
- 入组人数
- 250
- 试验地点
- 16
- 主要终点
- Measures of pain intensity difference
研究概览
简要总结
The purpose of this research study is to evaluate the safety and analgesic efficacy of PMI-150 (intranasal ketamine) compared to placebo in patients with acute post-operative pain following orthopedic trauma, injury, or surgery.
详细描述
Patients will be randomly assigned to PMI-150 (intranasal ketamine) or placebo and will receive repeated doses and be assessed for safety and efficacy.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient is scheduled for elective orthopedic surgery or procedure
排除标准
- •patient has received an investigational drug or participated in a clinical trial within 30 days or 5 half-lives (whichever is longer) of entering this study
研究组 & 干预措施
1
Experimental
PMI-150 (intranasal ketamine) at time 0 and specified time points thereafter.
干预措施: PMI-150 (intranasal ketamine) (Drug)
2
Placebo Comparator
Placebo at time 0 and specified time points thereafter.
干预措施: Placebo (Drug)
结局指标
主要结局
Measures of pain intensity difference
时间窗: 0-6 hours
次要结局
未报告次要终点
研究者
研究点 (16)
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