NCT02602353已完成2 期
A Phase 2, Randomized, Double-Blind, Parallel-Group and Placebo-Controlled Pilot Study to Assess the Safety and Efficacy of a New Pain Patch Versus Placebo and No Treatment for the Treatment of Delayed Onset Muscle Soreness (DOMS)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Sum of pain intensity differences over 24 hours from baseline (SPID 24) with movement
研究概览
简要总结
The purpose of this study is to evaluate the analgesic efficacy and safety of a new pain patch compared to placebo and no treatment in subjects experiencing Delayed Onset Muscle Soreness (DOMS).
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
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males or females, 18 to 40 years of age
- •are in good general health, with a BMI less than or equal to 32, and able to perform the exercise regimen
- •develops muscle pain/soreness within 24-48 hours of the end of the exercise regimen and have a baseline muscle pain/soreness with movement of greater than or equal to 5 on the Numerical Rating Scale (NRS) (numerical rating scale) and at least "moderate" on the categorical scale
排除标准
- •has engaged in upper extremity exercise for a minimum of 6 months prior to study participation
- •has been working heavy manual or physical labor jobs within 3 months prior to study participation.
- •has a known history of allergic reaction or clinically significant intolerance to acetaminophen, aspirin, or any nonsteroidal anti-inflammatory drugs
- •has skin lesions such as psoriasis at the application site
- •has abnormal skin condition such as eczema, contact dermatitis, pigment anomaly, etc.
- •has an allergy-related skin condition
研究组 & 干预措施
Loxoprofen Pain Patch
Experimental
One Active Pain Patch containing loxoprofen applied once daily for 3 days
干预措施: Loxoprofen Pain Patch (Drug)
Placebo Patch
Placebo Comparator
One Placebo Patch applied once daily for 3 days
干预措施: Placebo Patch (Drug)
No Treatment
Other
No Treatment for 3 days
干预措施: No Treatment (Drug)
结局指标
主要结局
Sum of pain intensity differences over 24 hours from baseline (SPID 24) with movement
时间窗: 0-24 hours
次要结局
- Sum of pain intensity differences over 24 hours from baseline (SPID 24) at rest(0-24 hours)
- Sum of pain intensity differences over 48 hours from baseline (SPID 48) with movement(0-48 hours)
- Sum of pain intensity differences over 48 hours from baseline (SPID 48) at rest(0-48 hours)
- Time to onset of first perceptible pain relief(First 4 hours after Dose 1)
- Time to onset of meaningful pain relief(First 4 hours after Dose 1)
- Subjects global impression of medication(Day 10)
研究者
研究点 (1)
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