Phase 4
N=252
FS-67 in the Treatment of Pediatric Patients With Ankle Sprain
Ankle Sprain
Bottom Line
View on ClinicalTrials.gov: NCT01037816 ↗Enrolled (actual)
252
Serious AEs
0.0%
Results posted
Oct 2022
Primary outcome: Primary: Primary: Sum of Pain Intensity Difference (SPID) at 8-hours (SPID8) Upon Monopodal Weight Bearing. — 107.19; 89.13 units on a scale — p=0.137
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- FS-67 Patch (Drug); Placebo Patch (Other)
- Age
- Pediatric · 13+ yrs
- Sex
- All
- Sponsor
- Hisamitsu Pharmaceutical Co., Inc.
- Primary completion
- Nov 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary: Sum of Pain Intensity Difference (SPID) at 8-hours (SPID8) Upon Monopodal Weight Bearing. |
107.19; 89.13 | 0.137 |
| SECONDARY Sum of Pain Intensity Difference at 8-hours (SPID8) at Rest. |
111.98; 86.89 | 0.044 sig |
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).
Eligibility Criteria
Inclusion Criteria
- Grade 1 or Grade 2 ankle sprain
Exclusion Criteria
- Pregnancy or lactation
Data sourced from ClinicalTrials.gov (NCT01037816). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.