NCT03348423已完成2 期
A Phase 2, Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Evaluation of the Efficacy and Safety of DEX-IN Following Painful Outpatient Procedures
Baudax Bio1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2017年11月15日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Evaluation of Pain Intensity - Mean Pain Score During Procedure
研究概览
简要总结
The primary objective of this study is to evaluate the analgesic efficacy of DEX-IN compared with placebo and active control (fentanyl), in subjects undergoing painful outpatient and office based procedures.
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)
盲法说明
Double-blind, double-dummy
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntarily provide written informed consent
- •Be planned to undergo a selected office-based or outpatient procedure
- •Be naïve to the planned procedure, i.e. no repeated or revision procedures
- •Not pregnant or planning to become pregnant, or using appropriate contraceptive measures.
排除标准
- •Known allergy to any study treatment or excipient
- •Have another painful physical condition or anxiety related diagnosis that may confound study assessments
- •Evidence of a clinically significant finding on physical examination, laboratory assessment, or ECG
- •Have signs or a history of significant nasal condition that may interfere with intranasal drug delivery
研究组 & 干预措施
DEX-IN 50 µg
Experimental
Dexmedetomidine Intranasal Spray
干预措施: DEX-IN (Drug)
Fentanyl 50 µg
Active Comparator
Intravenous Fentanyl
干预措施: Fentanyl (Drug)
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Evaluation of Pain Intensity - Mean Pain Score During Procedure
时间窗: Up to 4 Hours
Evaluation of subject reported pain intensity scores according to the 11-point Numeric Pain Rating Scale (NPRS; 0-10)
次要结局
未报告次要终点
研究者
研究点 (1)
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