Phase 4
Completed N=252
FS-67 in the Treatment of Pediatric Patients With Ankle Sprain
Ankle Sprain
Source: ClinicalTrials.gov NCT01037816 ↗
Enrolled (actual)
252
Serious AEs
0.0%
Results posted
Oct 2022
Primary outcomePrimary: 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
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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).
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 |
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. Informational only — not medical advice.