NCT01198834已完成3 期
A Randomized, Multi-Center, Double-Blind, Factorial, Comparator and Placebo-Controlled Phase III Trial to Evaluate the Efficacy, Tolerability and Safety of MRX-7EAT Etodolac-Lidocaine Topical Patch in the Treatment of Ankle Sprains
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 600
- 主要终点
- Mean of All Current Pain Intensity During Point and Flex Scores on Days 2 Through 7 on a 0-10 Numeric Pain Rating Scale (NPRS).
研究概览
简要总结
A Randomized, Multi-Center, Double-Blind, Factorial, Comparator and Placebo-Controlled Phase III Trial to Evaluate the Efficacy, Tolerability and Safety of MRX-7EAT Etodolac-Lidocaine Topical Patch in the Treatment of Ankle Sprains
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Placebo Patch
Placebo Comparator
Treatment with Placebo Patch
干预措施: Placebo (Drug)
MRX-7EAT Patch
Experimental
Treatment with MRX-7EAT Patch
干预措施: MRX-7EAT (Drug)
Lidocaine Patch
Experimental
Treatment with Lidocaine Patch
干预措施: Lidocaine (Drug)
Etodolac Patch
Experimental
Treatment with Etodolac Patch
干预措施: Etodolac (Drug)
结局指标
主要结局
Mean of All Current Pain Intensity During Point and Flex Scores on Days 2 Through 7 on a 0-10 Numeric Pain Rating Scale (NPRS).
时间窗: Days 2 to 7
次要结局
- Time to Pain Resolution(Days 1 to 7)
- Impact on Physical Function(Days 1 to 7)
- Current Pain Intensity during Point and Flex(Days 1 through 7)
- Current Pain Intensity at Rest, Passive Stretch and Pain Intensity While Standing On a Single Foot(Each Clinical Visit)
- Assessment of Patch Adherence(Clinical Visit 2)
- Subject's Treatment Satisfaction(Clinical Visit 3)
- Total Number of Patches Used(Days 1 to 7)
研究者
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