Placebo-controlled, Double-blind Evaluation Of The Efficacy And Safety Of Ibuprofen 5% Topical Gel For The Treatment Of Ankle Sprain
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 304
- 试验地点
- 19
- 主要终点
- Sum of Pain Intensity Difference (SPID) on Weight Bearing Over 3 Days (SPID WB0-3)
研究概览
简要总结
This study is being conducted to evaluate the effects of IBU 5% Topical Gel versus topical placebo for the relief of pain associated with a first or second degree ankle sprain. Both twice daily and three times daily regimens will be evaluated.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First or second degree ankle sprain within 48 hours of first dose of study medication
- •Medically cleared to participate
排除标准
- •Similar injury of same joint within last 6 months
- •Requires bed rest, surgery, or over-the-counter or prescription analgesics
研究组 & 干预措施
Topical IBU twice daily
干预措施: Topical IBU twice daily (Drug)
Placebo twice daily
干预措施: Placebo twice daily (Drug)
Topical IBU three times daily
干预措施: Topical IBU three times daily (Drug)
Placebo three times daily
干预措施: Placebo three times daily (Drug)
结局指标
主要结局
Sum of Pain Intensity Difference (SPID) on Weight Bearing Over 3 Days (SPID WB0-3)
时间窗: Over 3 Days (0-72 hours)
PI was assessed on an 11-point numerical rating scale from 0=no pain to 10=most severe pain. Pain intensity difference (PID) was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID was calculated as the time-weighted sum of PID scores over 3 days (72 hours). Total score ranges from -360 (higher pain relief) to 432 (lower pain relief) for SPID WB0-3. SPID is a value of change from baseline and as pain score at base line is usually higher than that at post baseline, a negative value of SPID indicates higher pain relief from baseline.
Sum of Ankle Pain Intensity Difference on Weight Bearing Over 24 Hours After Dose 1 (SPID WB24)
时间窗: 0 to 24 hours
PI was assessed on an 11-point numerical rating scale from 0=no pain to 10=most severe pain. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID was calculated as the time-weighted sum of PID scores over 24 hours. Total score ranges from -120 (higher pain relief) to 144 (lower pain relief) for SPID WB24. SPID is a value of change from baseline. Pain score at base line is usually higher than that at post baseline. So negative value of SPID indicates pain relief from baseline, while a positive value means a worst pain comparing to baseline, a negative value of SPID indicates higher pain relief from baseline.
次要结局
- Sum of Pain Intensity Difference at Rest Over 24 Hours on Day 1 (SPID R24)(0 to 24 hours)
- Change From Baseline in Participant's Global Assessment of Ankle Injury at Day 3 and 10(Baseline, Day 3, 10)
- Change From Baseline in Physician Global Assessment of Ankle Injury at Day 3 and 10(Baseline, Day 3, 10)
- Sum of Pain Intensity Difference at Rest and on Weight Bearing Over 6 Hours on Day 1 and Over 2 Hours on Day 3(Over 6 hours on Day 1, over 2 hours on Day 3)
- Time to Rescue Medication After Initial Dose, and After Each Subsequent Dose(Post-Dose on Day 1 up to Day 10)
- Number of Doses of Rescue Medication Used During the First 7 Days of Dosing(Baseline up to Day 7)
- Percentage of Participants Taking Rescue Medication(Post first dose Day 1 up to Day 10)
- Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points(Baseline, 1, 2, 3, 4, 5, 6, 12(Day1),24(Day2),30(Day2),36(Day2),48(Day3),50(Day3),54(Day3),60(Day3),72(Day4),78(Day4),84(Day4), 96(Day5),102(Day5), 108 (Day5), 120(Day6),126(Day6),132(Day6),144(Day7),150(Day7),156(Day7) hours post first dose on Day 1)
- Sum of Pain Intensity Difference Scores at Rest Over 3 Days(Over 3 Days (0-72 hours))
- Sum of Pain Intensity Difference Scores at Rest and on Weight Bearing Over 7 Days(Over 7 days (0-168 hours))
- Change From Baseline in Participant Assessment of Normal Function and Activity at Day 3 and 10(Baseline, Day 3, 10)
- Participant's Global Assessment of Medication at End of Study(Day 10)
- Time to First Perceptible Relief and Meaningful Relief(0 to 3 hours on Day 1)