A Randomized, Double-Blind, Placebo- and Active- Controlled, Single-Dose, Efficacy, Safety, and Pharmacokinetics Study of a Test Acetaminophen 500 mg Tablet in Postoperative Dental Pain
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 420
- 试验地点
- 1
- 主要终点
- Time to first confirmed perceptible pain relief
研究概览
简要总结
This is a Dental Pain Study which will evaluate the analgesic onset, efficacy and safety of 1000 mg acetaminophen as two Test acetaminophen 500 mg tablets, compared with commercial products of acetaminophen 1000 mg administered as two 500 mg caplets, and ibuprofen (IBU) 400 mg following third molar (wisdom tooth) extraction.
详细描述
This is a single-dose, randomized, double-blind, triple-dummy, placebo- and active controlled, parallel-group study to evaluate the analgesic onset, efficacy, and safety profile of Test acetaminophen 1000 mg compared with two commercial products over a six-hour period after third-molar extractions. Subjects will undergo dental extraction of three or four third molars.
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 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •17 years to 50 years old
- •Weight 100 lbs or greater with a body mass index (BMI) 18-30 inclusive
- •Dental extraction of three or four molars
- •Experience moderate to severe pain after extraction of third molars
- •Females of childbearing age must be willing to use acceptable method of birth control
排除标准
- •Currently pregnant or planning to be pregnant or nursing a baby
- •Known allergy to acetaminophen (ACM) or non-steroidal anti-inflammatory drugs (NSAIDS)
- •Inability to swallow whole large tablets or capsules
- •Have other conditions that the investigator feels may impact subject's safety and/or the integrity of the study
研究组 & 干预措施
Test acetaminophen
acetaminophen tablet and placebo caplet and placebo liquid-filled capsule
干预措施: Placebo Caplet (Drug)
Test acetaminophen
acetaminophen tablet and placebo caplet and placebo liquid-filled capsule
干预措施: Placebo Liquid-filled capsule (Drug)
Test acetaminophen
acetaminophen tablet and placebo caplet and placebo liquid-filled capsule
干预措施: acetaminophen Tablet (Drug)
Commercial acetaminophen
acetaminophen caplet and placebo tablet and placebo liquid-filled capsule
干预措施: acetaminophen Caplet (Drug)
Commercial acetaminophen
acetaminophen caplet and placebo tablet and placebo liquid-filled capsule
干预措施: Placebo Tablet (Drug)
Commercial acetaminophen
acetaminophen caplet and placebo tablet and placebo liquid-filled capsule
干预措施: Placebo Liquid-filled capsule (Drug)
Commercial ibuprofen
ibuprofen liquid-filled capsule and placebo tablet and placebo caplet
干预措施: ibuprofen Liquid-filled capsule (Drug)
Commercial ibuprofen
ibuprofen liquid-filled capsule and placebo tablet and placebo caplet
干预措施: Placebo Tablet (Drug)
Commercial ibuprofen
ibuprofen liquid-filled capsule and placebo tablet and placebo caplet
干预措施: Placebo Caplet (Drug)
Placebo
Placebo tablet and placebo caplet and placebo liquid-filled capsule
干预措施: Placebo Tablet (Drug)
Placebo
Placebo tablet and placebo caplet and placebo liquid-filled capsule
干预措施: Placebo Caplet (Drug)
Placebo
Placebo tablet and placebo caplet and placebo liquid-filled capsule
干预措施: Placebo Liquid-filled capsule (Drug)
结局指标
主要结局
Time to first confirmed perceptible pain relief
时间窗: 6 hours
Minutes until confirmed first perceptible pain relief are achieved. Stopwatch is started after the subject takes the study medication. The subject is instructed to stop the stopwatch when they first begin to feel any pain relief. The first perceptible pain relief is confirmed if the subject also stopped the second stopwatch indicating meaningful pain relief.
次要结局
- Percentage of subjects with confirmed perceptible relief from 30 minutes to successively earlier minutes in one-minute increments (Test ACM versus placebo)(30 minutes or less)
- Risk ratios of confirmed perceptible relief by 10 minutes (Test acetominophen and commercial ibuprofen)(10 minutes or less)
- Percentage of subjects with meaningful relief by 30 minutes(30 minutes or less)
- Risk ratios of confirmed perceptible relief by 15 minutes (Test acetominophen and commercial ibuprofen)(15 minutes or less)
- Risk ratios of confirmed perceptible relief by 20 minutes (Test acetominophen and commercial ibuprofen)(20 minutes or less)
- Time to meaningful pain relief(6 hours)