NCT01037816

FS-67 in the Treatment of Pediatric Patients With Ankle Sprain

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of FS-67 Patches in Adolescent Subjects With Ankle Sprain

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 252 (actual)
• Sponsor: Hisamitsu Pharmaceutical Co., Inc. · Industry
• Sex: All
• Age: 13 Years – 17 Years
• Healthy volunteers: Not accepted

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

Conditions

• Ankle Sprain

Interventions

Type	Name	Description
DRUG	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)
OTHER	Placebo Patch	One placebo patch applied to target ankle every 12 hours for three days (up to 6 FS-67 patches in three days)

Timeline

• Start date: 2009-12-01
• Primary completion: 2010-11-01
• Completion: 2010-12-01
• First posted: 2009-12-23
• Last updated: 2022-10-06
• Results posted: 2022-10-06

Locations

23 sites across 1 country: United States