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

Ankle Sprain Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of FS-67 Patches in Adolescent Subjects With Ankle Sprain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01037816
• Other study ID #: FS-67-HP01-E02
• Status: Completed
• Phase: Phase 4
• Start date: December 2009
• Est. completion date: December 2010

Study information

• Verified date: September 2022
• Source: Hisamitsu Pharmaceutical Co., Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 252
• Est. completion date: December 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 17 Years

Eligibility

Inclusion Criteria:

• Grade 1 or Grade 2 ankle sprain

Exclusion Criteria:

• Pregnancy or lactation

Related Conditions & MeSH terms

• Ankle Injuries
• Ankle Sprain
• Sprains and Strains

Intervention

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)

Locations

Country	Name	City	State
United States	Hisamitsu Investigator Site	Anaheim	California
United States	Hisamitsu Investigator Site	Bell Gardens	California
United States	Hisamitsu Investigator Site	Bellevue	Nebraska
United States	Hisamitsu Investigator Site	Berlin	New Jersey
United States	Hisamitsu Investigator Site	Birmingham	Alabama
United States	Hisamitsu Investigator Site	Boynton Beach	Florida
United States	Hisamitsu Investigator Site	Charlotte	North Carolina
United States	Hisamitsu Investigator Site	Columbus	Ohio
United States	Hisamitsu Investigator Site	Dayton	Ohio
United States	Hisamitsu Investigator Site	Daytona Beach	Florida
United States	Hisamitsu Investigator Site	Doral	Florida
United States	Hisamitsu Investigator Site	El Paso	Texas
United States	Hisamitsu Investigator Site	Evansville	Indiana
United States	Hisamitsu Investigator Site	Grapevine	Texas
United States	Hisamitsu Investigator Site	Hot Springs	Arkansas
United States	Hisamitsu Investigator Site	Jacksonville	Florida
United States	Hisamitsu Investigator Site	Las Vegas	Nevada
United States	Hisamitsu Investigator Site	Lincoln	Nebraska
United States	Hisamitsu Investigator Site	Long Beach	California
United States	Hisamitsu Investigator Site	Los Angeles	California
United States	Hisamitsu Investigator Site	Topeka	Kansas
United States	Hisamitsu Investigator Site	Tucson	Arizona
United States	Hisamitsu Investigator Site	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Hisamitsu Pharmaceutical Co., Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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