At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 252 enrolled
Drug / intervention
FS-67 Patch +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of FS-67 Patches in Adolescent Subjects With Ankle Sprain
In Brief
A Phase 4 clinical trial evaluating FS-67 Patch and Placebo Patch for Ankle Sprain. Completed, enrolled 252 participants across 23 sites.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnkle Sprain
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartDec 2009
First PostedDec 2009
Primary CompletionNov 2010
Study CompletionDec 2010
TodayJul 2026
First PostedDec 23, 2009
Enrollment StartDec 1, 2009
Primary CompletionNov 1, 2010
Study CompletionDec 1, 2010
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 16.5 years ago
Interventions
FS-67 Patchdrug
One FS-67 patch applied to target ankle every 12 hours for three days (up to 6 FS-67 patches in three days)
Placebo Patchother
One placebo patch applied to target ankle every 12 hours for three days (up to 6 FS-67 patches in three days)