A Single-Center, Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Efficacy, Safety, and Pharmacokinetics Study of Extended-Release (ER) Acetaminophen in Postoperative Dental Pain
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 403
- 试验地点
- 1
- 主要终点
- Time Weighted Sum of Pain Intensity Difference (PID) Over 10 Hours (SPID 0-10)
研究概览
简要总结
The purpose of the study is to evaluate the efficacy and safety of acetaminophen ER 1500 mg (two 750 mg tablets) over 10 to 12 hours in the dental pain model following third molar extraction(s) and to evaluate the pharmacokinetics of acetaminophen ER 1500 mg (two 750 mg tablets) in a sub-group of subjects.
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
- 17 Years 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be at least 17 and less than 46 years of age
- •Must weigh at least 100 lbs with a body mass index of at least 18 and less than 30
- •Scheduled to undergo surgical extraction of one impacted third molar from the lower jaw. The third molar from the upper jaw from the same side may also be removed.
- •Experiencing moderate to severe pain after extraction of third molars.
排除标准
- •Cannot be allergic to acetaminophen (Tylenol) or any non-steroidal anti-inflammatory drugs (e.g., Motrin, Advil, Aleve, Naproxen).
- •Cannot be pregnant (or planning to be pregnant) or nursing a baby
- •Unable to swallow whole large tablets or caplets.
- •Cannot have any other medical conditions that the investigator feels may compromise your safety or the study results.
研究组 & 干预措施
Acetaminophen ER
干预措施: Acetaminophen ER (Drug)
Placebo
Single dose (2 tablets) Acetaminophen ER 750 mg matching placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Time Weighted Sum of Pain Intensity Difference (PID) Over 10 Hours (SPID 0-10)
时间窗: 10 Hours
Time weighted sum of pain intensity difference scores from baseline over 10 hours. Pain intensity was evaluated using a 0-10 numerical rating scale (NRS) where 0 = no pain and 10 = very severe pain. SPID 0-10 = 0.25 x (PID at 15 min + PID at 30 min + PID at 45 min + PID at 60 min + PID at 75 min + PID at 90 min) + 0.5 x (PID at 120 min) + PID at 3 h + PID at 4 h + PID at 5 h + PID at 6 h + PID at 7 h + PID at 8 h + PID at 9 h + PID at 10 h.
次要结局
- Time to Confirmed First Perceptible Pain Relief(Within 12 Hours)
- Time to Meaningful Pain Relief(Within 12 Hours)
- Duration of Pain Relief(Within 12 Hours)
- Patient Global Evaluation(12 Hours)