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

Hisamitsu Pharmaceutical

Status and phase: Completed; Phase 4

Conditions: Ankle Sprain

Treatments: Other: Placebo Patch; Drug: FS-67 Patch

Study type: Interventional

Funder types: Industry

Identifiers

NCT01037816

FS-67-HP01-E02

Details and patient eligibility

About

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).

Full 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

Enrollment: 252 patients

Sex: All

Ages: 13 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Grade 1 or Grade 2 ankle sprain

Exclusion criteria

• Pregnancy or lactation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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252 participants in 2 patient groups, including a placebo group

FS-67 patch

Active Comparator group

Description:

One FS-67 patch applied to target ankle every 12 hours for three days (up to 6 FS-67 patches in three days)

Treatment:

Drug: FS-67 Patch

Placebo Patch

Placebo Comparator group

Description:

One placebo patch applied to target ankle every 12 hours for three days (up to 6 FS-67 patches in three days)

Treatment:

Other: Placebo Patch