A Multiple Dose Dental Pain Study Of An Ibuprofen 600 Mg Extended Release Caplet
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 106
- 试验地点
- 2
- 主要终点
- Time-weighted Sum of Pain Relief and Pain Intensity Difference Scores From 0 to 12 Hours After the First Dose (SPRID 0-12)
研究概览
简要总结
The study hypothesis is that single and multiple doses of ibuprofen 600 mg ER caplets provide analgesic efficacy superior to placebo over 12-hour dosing intervals.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females 16 to 40 years of age
- •Subjects who undergo surgical removal of at least two third molars
- •One of which must be a partial or full bony mandibular impaction
- •Subjects must have at least moderate baseline pain (a score of 2 on the categorical pain severity rating scale) confirmed by a score of at least 50 mm on the 100-mm visual analog scale-pain severity rating scale (VAS-PSR)
排除标准
- •Acute localized dental infection at the time of surgery that could confound the post-surgical evaluation
- •Presence or history of any significant organ disease
- •Use of prescription or OTC first generation antihistamines
- •Females who are pregnant, lactating or of childbearing potential and not using a medically approved method to prevent pregnancy
研究组 & 干预措施
Ibuprofen 600 mg extended release
干预措施: Ibuprofen 600 mg ER (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Time-weighted Sum of Pain Relief and Pain Intensity Difference Scores From 0 to 12 Hours After the First Dose (SPRID 0-12)
时间窗: Baseline to 12 hours
SPRID is time-weighted sum of pain relief (PR) plus pain intensity (PI) difference (PID) (PRID) scores. 5-point categorical scale for PR: "How much relief do you have from your starting pain?" (0 equals \[=\] none, 1=a little, 2=some, 3=a lot, 4=complete). 4-point categorical scale for PI: "How much pain do you have at this time?" (0=none, 1=mild, 2=moderate, 3=severe). PID score=baseline pain intensity score minus pain intensity at each time point; score ranged from -1 to 3; higher positive PID value indicated improvement in pain intensity. SPRID 0-12 score ranged from -12 to 84; higher score indicated better efficacy.
Sum of Pain Relief and Pain Intensity Difference Scores From 8-12 Hours After the First Dose
时间窗: 8 to 12 hours
SPRID is time-weighted sum of PR plus PID (PRID) scores. 5-point categorical scale for PR: "How much relief do you have from your starting pain?" (0=none, 1=a little, 2=some, 3=a lot, 4=complete). 4-point categorical scale for pain intensity: "How much pain do you have at this time?" (0=none, 1=mild, 2=moderate, 3=severe). PID score=baseline pain intensity score minus pain intensity at each time point; score ranged from -1 to 3; higher positive PID value indicated improvement (decrease) in pain intensity. SPRID 8-12 score ranged from -4 to 28; higher score indicated better efficacy.
次要结局
- Time-weighted Sum of Pain Relief Scores (TOTPAR)(0-12 hours, 8-12 hours)
- Time-weighted Sum of Pain Intensity Difference (SPID) Scores(0 to 12 hours, 8 to 12 hours, 12 to 24 hours, 20 to 24 hours, 0 to 24 hours, 24 to 36 hours, 32 to 36 hours, 36 to 48 hours, 44 to 48 hours, 24 to 48 hours)
- Percentage of Participants Taking Rescue Medication(Baseline to 48 hours)
- Pain Relief (PR) Scores(0.5, 1, 1.5, 2, 4, 6, 8, 10, 12 hours)
- Pain Intensity Difference (PID) Scores(0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 hours)
- Time to First Dose of Rescue Medication After First Dose of Study Drug(Baseline to 12 hours)
- Time to Confirmed First Perceptible Relief(Baseline to 12 hours)
- Pain Relief Combined With Pain Intensity (PRID) Scores(0.5, 1, 1.5, 2, 4, 6, 8, 10, 12 hours)
- Number of Doses of Rescue Medication Used(0-12, 12-24, 24-36, 36-48, 0-48 hours)
- Time to Meaningful Relief(Baseline to 12 hours)
- Participant Global Evaluation Score(24 and 48 hours)