A Randomized, Double-Blind, Placebo- and Active- Controlled, Efficacy and Safety Study of a Test Naproxen Sodium 220 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
- 501
- 试验地点
- 1
- 主要终点
- Time to Confirmed Perceptible Pain Relief
研究概览
简要总结
To evaluate analgesic onset, efficacy, and safety of a single dose of 440 mg of naproxen sodium administered as two Test Naproxen Sodium 220 mg tablets compared with two commercial naproxen sodium products (two naproxen sodium 220 mg tablets and two naproxen sodium 220 mg liquid gels capsules) and placebo in the dental pain model following third-molar extractions.
详细描述
This is a single-dose, randomized, double-blind, placebo- and active- controlled, parallel-group study to evaluate the analgesic onset, efficacy, and safety profile of 440 mg of naproxen sodium administered as two Test NPX 220 mg tablets compared with two commercial products and placebo over a twelve-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 - 50 years old
- •Weigh 100 pounds or greater and have a body mass index (BMI) of 17.5 to 30.4 (inclusive) at screening
- •Dental extraction of three or four third molars
- •Meets post-surgical pain
- •Females of childbearing potential and males agree to contraceptive requirements of study
- •Have a negative urine drug screen at screening, and on day of surgical procedure
排除标准
- •Pregnant female, breastfeeding, trying to be pregnant or male with pregnant partner or partner currently trying to become pregnant
- •Have a known allergy or hypersensitivity to naproxen or other NSAIDs, including aspirin, or to acetaminophen, hydrocodone or other opioids
- •Not able to swallow large tablets or capsules
- •History of any condition (s) in investigator's opinion, may jeopardize subject safety, well-being and integrity of study
- •Use analgesics 5 or more times per week
- •History of chronic tranquilizer use, heavy drinking, substance abuse as judged by investigator site staff within last 5 years
- •Use of immunosuppressive drugs within 2 weeks of screening
- •History of endoscopically documented peptic ulcer disease or bleeding disorder in last 2 years
研究组 & 干预措施
Test naproxen sodium tablet
Single dose of 440 mg of naproxen sodium administered as two Test Naproxen Sodium 220 mg tablets (Test NPX)
干预措施: Test naproxen sodium tablet (Drug)
Commercial naproxen sodium tablet
Single dose of 440 mg of naproxen sodium administered as two commercial naproxen sodium 220 mg tablets
干预措施: Commercial naproxen sodium tablet (Drug)
Commercial naproxen sodium liquid gels capsule
Single dose of 440 mg of naproxen sodium administered as two 220 mg commercial liquid gels capsules
干预措施: Commercial naproxen sodium liquid gels capsule (Drug)
Placebo tablet
Single dose of two Placebo tablets
干预措施: Placebo tablet (Drug)
结局指标
主要结局
Time to Confirmed Perceptible Pain Relief
时间窗: 12 hours
Minutes until confirmed first perceptible pain relief was achieved. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The first perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief.
次要结局
- Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments(Up to 45 minutes after dosing)