A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of FS-67 Patches in Adolescent Subjects With Ankle Sprain
Overview
- Phase
- Phase 4
- Intervention
- FS-67 Patch
- Conditions
- Ankle Sprain
- Sponsor
- Hisamitsu Pharmaceutical Co., Inc.
- Enrollment
- 252
- Locations
- 1
- Primary Endpoint
- Primary: Sum of Pain Intensity Difference (SPID) at 8-hours (SPID8) Upon Monopodal Weight Bearing.
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
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).
Detailed Description
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of FS-67 Patches in Adolescent Subjects With Ankle Sprain
Investigators
Eligibility Criteria
Inclusion Criteria
- •Grade 1 or Grade 2 ankle sprain
Exclusion Criteria
- •Pregnancy or lactation
Arms & Interventions
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)
Intervention: FS-67 Patch
Placebo Patch
One placebo patch applied to target ankle every 12 hours for three days (up to 6 FS-67 patches in three days)
Intervention: Placebo Patch
Outcomes
Primary Outcomes
Primary: Sum of Pain Intensity Difference (SPID) at 8-hours (SPID8) Upon Monopodal Weight Bearing.
Time Frame: 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.
Secondary Outcomes
- Sum of Pain Intensity Difference at 8-hours (SPID8) at Rest.(8 hours of patch application on Day 1)