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
1 other identifier
interventional
252
1 country
23
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Dec 2009
Shorter than P25 for phase_4
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2009
CompletedFirst Submitted
Initial submission to the registry
December 18, 2009
CompletedFirst Posted
Study publicly available on registry
December 23, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedResults Posted
Study results publicly available
October 6, 2022
CompletedOctober 6, 2022
September 1, 2022
11 months
December 18, 2009
September 4, 2020
September 9, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Sum of Pain Intensity Difference at 8-hours (SPID8) at Rest.
8 hours of patch application on Day 1
Study Arms (2)
FS-67 patch
ACTIVE COMPARATOROne FS-67 patch applied to target ankle every 12 hours for three days (up to 6 FS-67 patches in three days)
Placebo Patch
PLACEBO COMPARATOROne placebo patch applied to target ankle every 12 hours for three days (up to 6 FS-67 patches in three days)
Interventions
One FS-67 patch applied to target ankle every 12 hours for three days (up to 6 FS-67 patches in three days)
One placebo patch applied to target ankle every 12 hours for three days (up to 6 FS-67 patches in three days)
Eligibility Criteria
You may qualify if:
- Grade 1 or Grade 2 ankle sprain
You may not qualify if:
- Pregnancy or lactation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
Hisamitsu Investigator Site
Birmingham, Alabama, 35209, United States
Hisamitsu Investigator Site
Tucson, Arizona, 85705, United States
Hisamitsu Investigator Site
Tucson, Arizona, 85712, United States
Hisamitsu Investigator Site
Hot Springs, Arkansas, 71913, United States
Hisamitsu Investigator Site
Anaheim, California, 92804, United States
Hisamitsu Investigator Site
Bell Gardens, California, 90201, United States
Hisamitsu Investigator Site
Long Beach, California, 90806, United States
Hisamitsu Investigator Site
Los Angeles, California, 90036, United States
Hisamitsu Investigator Site
Boynton Beach, Florida, 33472, United States
Hisamitsu Investigator Site
Daytona Beach, Florida, 32117, United States
Hisamitsu Investigator Site
Doral, Florida, 33166, United States
Hisamitsu Investigator Site
Jacksonville, Florida, 32216, United States
Hisamitsu Investigator Site
Evansville, Indiana, 47714, United States
Hisamitsu Investigator Site
Topeka, Kansas, 66604, United States
Hisamitsu Investigator Site
Bellevue, Nebraska, 68005, United States
Hisamitsu Investigator Site
Lincoln, Nebraska, 68510, United States
Hisamitsu Investigator Site
Las Vegas, Nevada, 89106, United States
Hisamitsu Investigator Site
Berlin, New Jersey, 08009, United States
Hisamitsu Investigator Site
Charlotte, North Carolina, 28207, United States
Hisamitsu Investigator Site
Columbus, Ohio, 43214, United States
Hisamitsu Investigator Site
Dayton, Ohio, 45432, United States
Hisamitsu Investigator Site
El Paso, Texas, 79902, United States
Hisamitsu Investigator Site
Grapevine, Texas, 76051, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Yoshinobu Higashi, Section Manager, International Regulatory Affairs
- Organization
- Hisamitsu Pharmaceutical Co., Inc.
Study Officials
- STUDY DIRECTOR
Yoshinobu Higashi
Hisamitsu Pharmaceutical Co., Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 18, 2009
First Posted
December 23, 2009
Study Start
December 1, 2009
Primary Completion
November 1, 2010
Study Completion
December 1, 2010
Last Updated
October 6, 2022
Results First Posted
October 6, 2022
Record last verified: 2022-09