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

NCT01037816 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 252

Last updated 2022-10-06

Study results available
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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).

Conditions

  • Ankle Sprain

Interventions

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)

Sponsors & Collaborators

  • Hisamitsu Pharmaceutical Co., Inc.

    lead INDUSTRY

Principal Investigators

  • Yoshinobu Higashi · Hisamitsu Pharmaceutical Co., Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
13 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2010-11-30
Completion
2010-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01037816 on ClinicalTrials.gov