A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Five Strengths of a Fixed Combination of Acetaminophen/Naproxen Sodium in Postoperative Dental Pain
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 304
- 试验地点
- 1
- 主要终点
- Time Weighted Sum of Pain Intensity Difference Score From Baseline (0 Hour) to 12 Hours (SPID 0-12)
研究概览
简要总结
Study assessing the relative efficacy of five strengths of a fixed combination of acetaminophen and naproxen sodium is being investigated to help inform selection of dose(s) for further development and to evaluate the safety of a fixed combination of naproxen sodium and acetaminophen.
详细描述
This is a randomized, double-blind, placebo-controlled study to evaluate the analgesic efficacy and safety profile of the following doses of a fixed combination of Acetaminophen (APAP)/Naproxen sodium (NPX) administered as a single two-tablet dose:[Acetaminophen/Naproxen Sodium Dose A, Acetaminophen/Naproxen Sodium Dose B, Acetaminophen/Naproxen Sodium Dose C, Acetaminophen/Naproxen Sodium Dose D, Acetaminophen/Naproxen Sodium Dose E and Placebo] following surgical extraction of 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
- •Males or females 17-50 years old
- •Weigh 100 pounds or greater and have a body mass index (BMI) of 17.5-35.4 (inclusive) at screening
- •Surgical removal of three or four third molars, of which, two must be mandibular impactions
- •Meets requirements for post-surgical pain level
- •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 become 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, oxycodone or other opioids;
- •Not able to swallow whole 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, or substance abuse, as judged by the investigator site staff, in the last 5 years
- •Use of any immunosuppressive drugs within 2 weeks of screening
- •History of endoscopically documented peptic ulcer disease or bleeding disorder in the last 2 years
研究组 & 干预措施
Acetaminophen/naproxen sodium Dose D
Acetaminophen/naproxen sodium Dose D administered as a single two-tablet dose.
干预措施: Acetaminophen/naproxen sodium Dose D (Drug)
Acetaminophen/naproxen sodium Dose A
Acetaminophen/naproxen sodium Dose A administered as a single two-tablet dose.
干预措施: Acetaminophen/naproxen sodium Dose A (Drug)
Acetaminophen/naproxen sodium Dose B
Acetaminophen/naproxen sodium Dose B administered as a single two-tablet dose.
干预措施: Acetaminophen/naproxen sodium Dose B (Drug)
Acetaminophen/naproxen sodium Dose C
Acetaminophen/naproxen sodium Dose C administered as a single two-tablet dose.
干预措施: Acetaminophen/naproxen sodium Dose C (Drug)
Acetaminophen/naproxen sodium Dose E
Acetaminophen/naproxen sodium Dose E administered as a single two-tablet dose.
干预措施: Acetaminophen/naproxen sodium Dose E (Drug)
Placebo
Placebo tablets administered as a single two-tablet dose.
干预措施: Placebo (Drug)
结局指标
主要结局
Time Weighted Sum of Pain Intensity Difference Score From Baseline (0 Hour) to 12 Hours (SPID 0-12)
时间窗: Baseline (0 hour) up to 12 hours post-dose on Day 1
Time weighted sum of the pain intensity difference (SPID) score is derived from pain intensity difference (PID) score. Pain intensity-numerical rating scale (PI-NRS) was used to assess pain intensity on scale ranged from 0 (no pain) to 10 (very severe pain), higher score indicated severe pain intensity. PID score was the difference between baseline pain intensity and pain intensity at assessment timepoint (12 hours). The SPID scores were derived by first multiplying each PID score by the time from the previous time point and adding these time weighted PID scores together over the interval from 0 to 12 hours. The possible range of SPID for 0 to 12 hours was from -120 to 120. A higher value of SPID indicated greater pain relief.
次要结局
- Time Weighted Sum of Pain Intensity Difference Score From 6 Hours to 12 Hours (SPID 6-12)(From 6 hours up to 12 hours post-dose on Day 1)
- Time to First Use of Rescue Analgesic Medication(From 0 minute up to 1440 minutes post-dose (that is, up to 24 hours post-dose) on Day 1)
- Proportion of Participants Who Required Rescue Analgesic Medication(From 0 hour up to 24 hours post-dose on Day 1)
- Time Weighted Sum of Total Pain Relief Score From Baseline (0 Hour) to 12 Hours (TOTPAR 0-12)(Baseline (0 hour) up to 12 hours post-dose on Day 1)