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

H

Hisamitsu Pharmaceutical Co., Inc.

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

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

Trial contacts and locations

23

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Data sourced from clinicaltrials.gov

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