A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of FS-67 Patches in Adolescent Subjects With Ankle Sprain
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 252
- 试验地点
- 1
- 主要终点
- Primary: Sum of Pain Intensity Difference (SPID) at 8-hours (SPID8) Upon Monopodal Weight Bearing.
研究概览
简要总结
The objective of this study is assess the efficacy and safety of single and multiple applications of the FS-67 patch in the treatment of ankle sprain in pediatric population (ages 13-17).
详细描述
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of FS-67 Patches in Adolescent Subjects With Ankle 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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 13 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Grade 1 or Grade 2 ankle sprain
排除标准
- •Pregnancy or lactation
研究组 & 干预措施
FS-67 patch
One FS-67 patch applied to target ankle every 12 hours for three days (up to 6 FS-67 patches in three days)
干预措施: FS-67 Patch (Drug)
Placebo Patch
One placebo patch applied to target ankle every 12 hours for three days (up to 6 FS-67 patches in three days)
干预措施: Placebo Patch (Other)
结局指标
主要结局
Primary: Sum of Pain Intensity Difference (SPID) at 8-hours (SPID8) Upon Monopodal Weight Bearing.
时间窗: 8 hours of patch application on Day 1
Summed Pain Intensity Differences (SPID8) worst observation carried forward (WOCF) during monopodal weight-bearing on the affected ankle observed at specified time-points (1, 2, 4, 6, \& 8 hrs) after patch application. The SPID8 (WOCF) is a time-weighted sum of the pain intensity differences (PID), which were calculated as change from pain intensity at baseline to pain intensity at specified time points. Pain intensity was evaluated by means of a 100 mm visual analog scale (VAS), on which 0 mm represented no pain and 100 mm represented the worst pain imaginable. SPID8 was derived as the time-weighted sum (area under the curve) of the PID, where the weight assigned to each PID score is equal to the elapsed time (in hrs) since the previous scheduled evaluation time point. Five time-points were observed to calculate SPID8 therefore the potential SPID8 scores could range from -500 to +500 with negative values indicating increased pain over 8 hours.
次要结局
- Sum of Pain Intensity Difference at 8-hours (SPID8) at Rest.(8 hours of patch application on Day 1)