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

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 Overview

• Status: Completed
• Conditions: Ankle Sprain
• Intervention / Treatment: Drug: FS-67 Patch; Other: Placebo Patch

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

• Study Type: Interventional
• Enrollment (Actual): 252
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35209
      • Hisamitsu Investigator Site
  • Arizona
    • Tucson, Arizona, United States, 85705
      • Hisamitsu Investigator Site
    • Tucson, Arizona, United States, 85712
      • Hisamitsu Investigator Site
  • Arkansas
    • Hot Springs, Arkansas, United States, 71913
      • Hisamitsu Investigator Site
  • California
    • Anaheim, California, United States, 92804
      • Hisamitsu Investigator Site
    • Bell Gardens, California, United States, 90201
      • Hisamitsu Investigator Site
    • Long Beach, California, United States, 90806
      • Hisamitsu Investigator Site
    • Los Angeles, California, United States, 90036
      • Hisamitsu Investigator Site
  • Florida
    • Boynton Beach, Florida, United States, 33472
      • Hisamitsu Investigator Site
    • Daytona Beach, Florida, United States, 32117
      • Hisamitsu Investigator Site
    • Doral, Florida, United States, 33166
      • Hisamitsu Investigator Site
    • Jacksonville, Florida, United States, 32216
      • Hisamitsu Investigator Site
  • Indiana
    • Evansville, Indiana, United States, 47714
      • Hisamitsu Investigator Site
  • Kansas
    • Topeka, Kansas, United States, 66604
      • Hisamitsu Investigator Site
  • Nebraska
    • Bellevue, Nebraska, United States, 68005
      • Hisamitsu Investigator Site
    • Lincoln, Nebraska, United States, 68510
      • Hisamitsu Investigator Site
  • Nevada
    • Las Vegas, Nevada, United States, 89106
      • Hisamitsu Investigator Site
  • New Jersey
    • Berlin, New Jersey, United States, 08009
      • Hisamitsu Investigator Site
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • Hisamitsu Investigator Site
  • Ohio
    • Columbus, Ohio, United States, 43214
      • Hisamitsu Investigator Site
    • Dayton, Ohio, United States, 45432
      • Hisamitsu Investigator Site
  • Texas
    • El Paso, Texas, United States, 79902
      • Hisamitsu Investigator Site
    • Grapevine, Texas, United States, 76051
      • Hisamitsu Investigator Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 15 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Grade 1 or Grade 2 ankle sprain

Exclusion Criteria:

• Pregnancy or lactation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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)	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 Names: Topical Patch
Placebo Comparator: Placebo Patch; One placebo 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); Other Names: Sham treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary: Sum of Pain Intensity Difference (SPID) at 8-hours (SPID8) Upon Monopodal Weight Bearing.	Summed Pain Intensity Differences (SPID8) worst observation carried forward (WOCF) during monopodal weight-bearing on the affected ankle observed at specified time-points (1, 2, 4, 6, & 8 hrs) after patch application. The SPID8 (WOCF) is a time-weighted sum of the pain intensity differences (PID), which were calculated as change from pain intensity at baseline to pain intensity at specified time points. Pain intensity was evaluated by means of a 100 mm visual analog scale (VAS), on which 0 mm represented no pain and 100 mm represented the worst pain imaginable. SPID8 was derived as the time-weighted sum (area under the curve) of the PID, where the weight assigned to each PID score is equal to the elapsed time (in hrs) since the previous scheduled evaluation time point. Five time-points were observed to calculate SPID8 therefore the potential SPID8 scores could range from -500 to +500 with negative values indicating increased pain over 8 hours.	8 hours of patch application on Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sum of Pain Intensity Difference at 8-hours (SPID8) at Rest.	Summed Pain Intensity Differences (SPID8) worst observation carried forward (WOCF) at rest observed at specified time-points (1, 2, 4, 6, & 8 hrs) after patch application. The SPID8 (WOCF) is a time-weighted sum of the pain intensity differences (PID), which were calculated as change from pain intensity at baseline to pain intensity at specified time points. Pain intensity was evaluated by means of a 100 mm visual analog scale (VAS), on which 0 mm represented no pain and 100 mm represented the worst pain imaginable. SPID8 was derived as the time-weighted sum (area under the curve) of the PID, where the weight assigned to each PID score is equal to the elapsed time (in hrs) since the previous scheduled evaluation time point. Five time-points were observed to calculate SPID8 therefore the potential SPID8 scores could range from -500 to +500 with negative values indicating increased pain over 8 hours.	8 hours of patch application on Day 1

Collaborators and Investigators

• Sponsor: Hisamitsu Pharmaceutical Co., Inc.
• Investigators: Study Director: Yoshinobu Higashi, Hisamitsu Pharmaceutical Co., Inc.

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (Actual): November 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: December 18, 2009
• First Submitted That Met QC Criteria: December 22, 2009
• First Posted (Estimate): December 23, 2009

Study Record Updates

• Last Update Posted (Actual): October 6, 2022
• Last Update Submitted That Met QC Criteria: September 9, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Ankle Sprain
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Sprains and Strains; Ankle Injuries
• Other Study ID Numbers: FS-67-HP01-E02