A Phase II, Randomized, Double-blind, Active Comparator, Parallel Group Study to Evaluate the Efficacy and Safety of K-285 Compared With Menthol Gel for the Treatment of Delayed Onset Muscle Soreness (DOMS) in the Lower Extremity
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Sum of Pain Intensity Difference Between 0 to 24 Hours (SPID0-24) for Study Leg While Standing
研究概览
简要总结
The purpose of this study to evaluate the efficacy and safety of K-285 compared with menthol gel for the treatment of delayed onset muscle soreness (DOMS) in the lower extremity.
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, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject must provide informed consent before any study-specific evaluation is performed.
- •Subject is male and female aged 18 to 35 years, inclusive.
- •Subject has a body mass index of 18 to 32 kg/m2, inclusive.
- •Subject meets all inclusion criteria outlined in the Clinical Study Protocol.
排除标准
- •Subject has a job (e.g., movers, construction workers) that requires regular lifting or involvement of the lower extremities.
- •Subject has restless leg syndrome, a chronic pain condition, a history of intermittent claudication, or has taken any medication (e.g., analgesic medication, sleep medication, muscle relaxant, anticonvulsant, or antidepressant) in the last 6 months to treat a chronic pain condition, or has another painful physical condition in a lower extremity that, in the opinion of the investigator, may confound study assessments.
- •Subject has received oral or topical analgesic medications within 14 days before the Screening Visit.
- •Subject meet any other exclusion criteria outlined in the Clinical Study Protocol.
研究组 & 干预措施
Treatment Arm A
K-285
干预措施: K-285 (Drug)
Treatment Arm B
Menthol
干预措施: Menthol (Drug)
结局指标
主要结局
Sum of Pain Intensity Difference Between 0 to 24 Hours (SPID0-24) for Study Leg While Standing
时间窗: Baseline to 24 Hours
* Pain Intensity (PI) was assessed for study leg while standing using a patient rated 0-100 point scale where 0 = 'no Pain' and 100 = 'worst possible pain. Pain Intensity Differences (PID) was the difference between PI at time (i) minus PI at time (t+1). The Sum of Pain Intensity Difference (SPID) was calculated as a time-weighted Sum of PID scores over a number of hours. * Sum of pain intensity differences over 24 hours after initiating treatment (SPID24). SPID24 derived from pain scores assessed over 24 hours on a 0 -100 point scale. SPID24 was computed using the trapezoidal rule, i.e. Σ \[T(i+1) - T(i)\] x \[((PID)(i+1) + PID(i))/2\] in an obvious notation, where T(i) is nominal time and PID(i), the pain intensity difference at Time (i). * Negative differences correspond to an improvement of pain, while positive differences correspond to recrudescence of pain. A higher negative value of SPID indicates greater pain relief.
次要结局
- SPID0-24 at Rest for Study Leg(Baseline to 24 Hours)
- SPID0-12 While Standing for Study Leg(Baseline to 12 Hours)
- SPID0-12 at Rest for Study Leg(Baseline to 12 Hours)
- SPID0-48 While Standing for Study Leg(Baseline to 48 Hours)
- SPID0-48 at Rest for Study Leg(Baseline to 48 Hours)
- SPID0-72 While Standing for Study Leg(Baseline to 72 Hours)
- SPID0-72 at Rest for Study Leg(Baseline to 72 Hours)