A Randomized, Double-Blind,Vehicle-Controlled Study to Determine the Efficacy and Safety of AP0302 in the Treatment of Delayed Onset Muscle Soreness (DOMS)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 251
- 试验地点
- 1
- 主要终点
- Sum of the Time-weighted Differences From Baseline in Pain Intensity With Movement(SPIDMOVE) Over 24 Hours Post Time Zero
研究概览
简要总结
Phase 2 study designed to evaluated analgesic efficacy and safety of S-Ibuprofen Topical Gel 5%
详细描述
The purpose of this randomized, double-blind study is to evaluate the efficacy and safety of S-Ibuprofen Topical Gel 5% in reducing pain/soreness associated with 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
active gel and matching vehicle control gel
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •history of pain/soreness after exercise
- •BMI between 18-30
- •negative drug, alcohol, pregnancy screens
- •other protocol-defined inclusion criteria may apply
排除标准
- •upper extremity workout in last 3 months
- •job or hobby requiring heavy lifting
- •history of muscle disorders
- •allergy or intolerance to NSAID or study drug
- •history of recent pain medication use
- •other protocol-defined exclusion criteria may apply
研究组 & 干预措施
Active Arm
S-Ibuprofen Topical Gel 5%
干预措施: S-Ibuprofen (Drug)
Placebo Arm
Vehicle Topical Gel
干预措施: Vehicle (Drug)
结局指标
主要结局
Sum of the Time-weighted Differences From Baseline in Pain Intensity With Movement(SPIDMOVE) Over 24 Hours Post Time Zero
时间窗: 0-24 hours.
The primary efficacy outcome is the sum of the time-weighted differences from baseline in muscle pain/soreness with movement over 0-24 hours post T0 (SPIDMOVE 0-24h), that is the area under the differences from baseline pain/soreness intensity difference curve. The pain intensity differences (PIDs) with movement from time point A to time point B was calculated using the trapezoid rule by subtracting each post-T0 pain score with movement from the pain score with movement at time point Ti. Positive and higher scores indicate greater reduction in pain. Measured by Pain Intensity Numerical Rating Scale (PI-NRS) where 0 = no pain and 10 = worst possible pain at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 16, 20, 24, 26, 28, 30, 32, 34, 36, 40, 44, and 48 hours post-initial IP dose and immediately prior to the subsequent doses of investigational product (IP).
次要结局
- Subject Global Assessment of Study Medication Assessed at Approximately 48 Hours Post Time Zero(48 hours post time zero)
- Sum of Time Weighted Differences From Baseline in Muscle Stiffness (SSID) With Movement Over the Interval(0-6, 6-12, 0-12, 12-24, 24-36, 24-48, 0-36, 36-48, and 0-48 post T0)
- Total Relief With Movement (TOTPAR) 0-6 Hours Post Time Zero(0-6 hours)
- Number of Participants With Treatment-emergent Adverse Events (TEAEs)(Up to Day 7)
- SPIDMOVE Over the Following Intervals: 0-6, 6-12, 0-12, 12-24, 24-36, 24-48, 0-36, 36-48 and 0-48 Hours Post-T0.(From 0-6, 6-12, 0-12, 12-24, 24-36, 0-36, 24-28,36-48, and 0-48 hours post-T0. Time point i included 1, 2, 3, 4, 5, 6 (pre-dose), 7, 8, 9, 10, 11, 12 (pre-dose), 16, 18 (pre-dose), 20, and 24 (pre-dose) hours after the first dose.)