A Randomized, Placebo-Controlled, Double-Blind, Two-Part, Cross-over Study in Healthy Adult Male Subjects to Compare the Reduction in Pain Intensity After Single-Dose Administration of Intravenous or Oral Acetaminophen and Intravenous Morphine by Using UVB Burn and Intradermal Capsaicin Experimental Pain Models
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Mallinckrodt
- 入组人数
- 79
- 试验地点
- 1
- 主要终点
- Part 1: Change From Baseline in Pain Intensity at Hour 6 Using the Thermal Suprathreshold Pain in the Ultraviolet-B (UVB) Burn Pain Model
研究概览
简要总结
The purpose of this study is to evaluate two experimental pain models to see if they would be useful for comparing different products for reduction in pain intensity.
The models evaluated were the ultraviolet-B (UVB) burn and intradermal capsaicin experimental pain models. Medications compared were a single dose each, of intravenous (IV) acetaminophen, oral acetaminophen, placebo, and IV morphine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
IV Acetaminophen
All participants receive IV acetaminophen as one of 4 interventions in random sequence
干预措施: IV Acetaminophen (Treatment A) (Drug)
IV Acetaminophen
All participants receive IV acetaminophen as one of 4 interventions in random sequence
干预措施: Placebo (Treatment C) (Drug)
Oral Acetaminophen
All participants receive oral acetaminophen as one of 4 interventions in random sequence
干预措施: Oral Acetaminophen (Treatment B) (Drug)
Oral Acetaminophen
All participants receive oral acetaminophen as one of 4 interventions in random sequence
干预措施: Placebo (Treatment C) (Drug)
Placebo
All participants receive placebo as one of 4 interventions in random sequence
干预措施: Placebo (Treatment C) (Drug)
Morphine
All participants receive morphine as one of 4 interventions in random sequence
干预措施: Placebo (Treatment C) (Drug)
Morphine
All participants receive morphine as one of 4 interventions in random sequence
干预措施: Morphine (Treatment D) (Other)
结局指标
主要结局
Part 1: Change From Baseline in Pain Intensity at Hour 6 Using the Thermal Suprathreshold Pain in the Ultraviolet-B (UVB) Burn Pain Model
时间窗: within 6 hours
The UVB burn pain model is a validated screening tool for pain killers in clinical drug development. A temperature of 50 degrees centigrade (°C) is used to burn the participant for 5 seconds. Then the participant rates his pain on a scale from 0 (no pain) to 10 (most intense pain). That score is recorded as baseline. Then the participant rates his pain again six hours after taking the assigned medication. The average at baseline is subtracted from the average at hour 6. Because this is a measure of reduction in pain intensity, a higher score is better (it means there is more pain relief).
次要结局
- Part 2: Observed Thermal Suprathreshold Pain Intensity in the UVB Burn Area(within 6 hours)