EVALUATION OF THE EFFICACY OF NOVEL IBUPROFEN ACETAMINOPHEN COMBINATION FORMULATIONS IN THE TREATMENT OF POST-SURGICAL DENTAL PAIN
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 394
- 试验地点
- 1
- 主要终点
- Time-Weighted Sum of Pain Relief Rating and Pain Intensity Difference Scores From 0 to 8 Hours (SPRID 0-8)
研究概览
简要总结
This study will determine the overall analgesic efficacy of three different fixed dose ibuprofen plus acetaminophen formulations compared to ibuprofen alone and to placebo.
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
- Double (Participant, Investigator)
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
- •Moderate to severe post-operative pain following surgical extraction of three or more third molar teeth
排除标准
- •Presence of history of significant hepatic, renal, endocrine, cardiovascular, neurological, psychiatric, gastrointestinal, pulmonary, hematologic or metabolic disorder
- •Pregnant or breastfeeding females
研究组 & 干预措施
Ibuprofen/acetaminophen (lower dose)
干预措施: Ibuprofen/acetaminophen (Drug)
Ibuprofen/acetaminophen (middle dose)
干预措施: Ibuprofen/acetaminophen (Drug)
Ibuprofen/acetaminophen (high dose)
干预措施: Ibuprofen/acetaminophen (Drug)
Ibuprofen
干预措施: Ibuprofen (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Time-Weighted Sum of Pain Relief Rating and Pain Intensity Difference Scores From 0 to 8 Hours (SPRID 0-8)
时间窗: From 0 hour up to 8 hours post-dose
SPRID4:Time-weighted sum of pain relief rating (PRR) and pain intensity difference (PID) based on 4 point categorical severity rating scale (PRID) over 8 hours.SPRID 0-8 score range:-8 (worst score) to 56 (best score).PRID: sum of PRR and PID at each time point.PRID score range:-1= worst score to 7= best score.PID4 was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 \[none\] to 3 \[severe\]) from the baseline pain intensity scores (score range: 2 =moderate pain to 3 = severe pain; as participants with baseline pain score of at least moderate were included in study). Total possible score range for PID: -1 (worst score) to 3 (best score).PRR assessed on 5-point categorical scale with range:0 =no relief to 4 =complete relief.
次要结局
- Pain Intensity Difference on 4-Point Categorical Scale (PID4)(0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose)
- Pain Intensity Difference on 11-Point Numerical Scale (PID11)(0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose)
- Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4)(0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose)
- Cumulative Percentage of Participants With Treatment Failure(1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose)
- Time to Confirmed First Perceptible Relief(From 0 hour up to 12 hours post-dose)
- Pain Relief Rating Score (PRR)(0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose)
- Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (SPRID4) Over 2, 6 and 12 Hours Post Dose(0 to 2 hours, 0 to 6 hours, 0 to 12 hours post-dose)
- Cumulative Percentage of Participants With Meaningful Relief(0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose)
- Time-weighted Sum of Pain Relief Rating (TOTPAR) Over 2, 6, 8, 12 Hours Post-Dose(0 to 2 hours, 0 to 6 hours, 0 to 8 hours, 0 to 12 hours post-dose)
- Time to Onset of Meaningful Pain Relief(From 0 hour up to 12 hours post-dose)
- Time-weighted Sum of Pain Intensity Difference on 4-Point Categorical Scale (SPID4) Over 2, 6, 8 and 12 Hours Post-Dose(0 to 2 hours, 0 to 6 hours, 0 to 8 hours, 0 to 12 hours post-dose)
- Time-weighted Sum of Pain Intensity Difference on 11-Point Numerical Scale (SPID11) Over 2, 6, 8 and 12 Hours Post-Dose(0 to 2 hours, 0 to 6 hours, 0 to 8 hours, 0 to 12 hours post-dose)
- Cumulative Percentage of Participants With Confirmed First Perceptible Relief(0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose)
- Time to Treatment Failure(From 0 hour up to 12 hours post-dose)
- Participant Global Evaluation of Study Medication(12 hour)