NCT02089425终止3 期
An Efficacy and Safety Study for the Treatment of Mild to Moderate Acute Pain Associated With Ankle Strain or Sprain.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 384
- 主要终点
- Sum of Pain Intensity Difference(SPID) 0-72
研究概览
简要总结
This is a randomized, double blind, placebo controlled, parallel group study to assess the efficacy and safety of K-103-IP compared with placebo patch for treatment of mild to moderate acute pain associated with ankle strain or sprain.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must provide informed consent before any study specific evaluation is performed.
- •Subject is male or female aged 18 to 70 years, inclusive.
- •Subject has a grade 1 (mild functional impairment) or grade 2 (moderate functional impairment) ankle strain or sprain that occurred within 48 hours before the Screening visit.
- •Subject has pain intensity upon monopodal weight bearing of 5 to 8, inclusive, measured by an 11 point nominal rating scale (NRS), plus pain intensity score at rest that is less than upon monopodal weight bearing.
排除标准
- •Subject has a grade 3 (severe functional impairment) strain or sprain, bilateral strain or sprain, or concomitant fracture or wound at the site of the strain or sprain.
- •Subject has had an ankle strain or sprain to the same foot within 6 months before the Screening visit.
- •Subject has received topical analgesic medication within 24 hours before the Screening visit.
- •Subject has applied ice or compression to the injured area within 2 hours before the Screening visit.
研究组 & 干预措施
K-103-IP
Experimental
K-103-IP: 0.5% indomethacin
干预措施: K-103-IP (Drug)
Placebo
Placebo Comparator
Placebo patch: 0% indomethacin
干预措施: Placebo (Drug)
结局指标
主要结局
Sum of Pain Intensity Difference(SPID) 0-72
时间窗: 72 Hours
次要结局
- Mean change from Baseline in pain intensity difference (PID)(168 Hours)
研究者
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