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

Primary Purpose

Ankle Sprain

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
FS-67 Patch
Placebo Patch
Sponsored by
Hisamitsu Pharmaceutical Co., Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankle Sprain focused on measuring Ankle Sprain

Eligibility Criteria

13 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Grade 1 or Grade 2 ankle sprain

Exclusion Criteria:

  • Pregnancy or lactation

Sites / Locations

  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

FS-67 patch

Placebo Patch

Arm Description

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)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
December 18, 2009
Last Updated
September 9, 2022
Sponsor
Hisamitsu Pharmaceutical Co., Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01037816
Brief Title
FS-67 in the Treatment of Pediatric Patients With Ankle Sprain
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hisamitsu Pharmaceutical Co., Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Sprain
Keywords
Ankle Sprain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
252 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FS-67 patch
Arm Type
Active Comparator
Arm Description
One FS-67 patch applied to target ankle every 12 hours for three days (up to 6 FS-67 patches in three days)
Arm Title
Placebo Patch
Arm Type
Placebo Comparator
Arm Description
One placebo patch applied to target ankle every 12 hours for three days (up to 6 FS-67 patches in three days)
Intervention Type
Drug
Intervention Name(s)
FS-67 Patch
Other Intervention Name(s)
Topical Patch
Intervention Description
One FS-67 patch applied to target ankle every 12 hours for three days (up to 6 FS-67 patches in three days)
Intervention Type
Other
Intervention Name(s)
Placebo Patch
Other Intervention Name(s)
Sham treatment
Intervention Description
One placebo patch applied to target ankle every 12 hours for three days (up to 6 FS-67 patches in three days)
Primary Outcome Measure Information:
Title
Primary: Sum of Pain Intensity Difference (SPID) at 8-hours (SPID8) Upon Monopodal Weight Bearing.
Description
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.
Time Frame
8 hours of patch application on Day 1
Secondary Outcome Measure Information:
Title
Sum of Pain Intensity Difference at 8-hours (SPID8) at Rest.
Description
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.
Time Frame
8 hours of patch application on Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Grade 1 or Grade 2 ankle sprain Exclusion Criteria: Pregnancy or lactation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yoshinobu Higashi
Organizational Affiliation
Hisamitsu Pharmaceutical Co., Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Hisamitsu Investigator Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Hisamitsu Investigator Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85705
Country
United States
Facility Name
Hisamitsu Investigator Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Hisamitsu Investigator Site
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Facility Name
Hisamitsu Investigator Site
City
Anaheim
State/Province
California
ZIP/Postal Code
92804
Country
United States
Facility Name
Hisamitsu Investigator Site
City
Bell Gardens
State/Province
California
ZIP/Postal Code
90201
Country
United States
Facility Name
Hisamitsu Investigator Site
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Hisamitsu Investigator Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
Country
United States
Facility Name
Hisamitsu Investigator Site
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33472
Country
United States
Facility Name
Hisamitsu Investigator Site
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32117
Country
United States
Facility Name
Hisamitsu Investigator Site
City
Doral
State/Province
Florida
ZIP/Postal Code
33166
Country
United States
Facility Name
Hisamitsu Investigator Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Hisamitsu Investigator Site
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
Hisamitsu Investigator Site
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66604
Country
United States
Facility Name
Hisamitsu Investigator Site
City
Bellevue
State/Province
Nebraska
ZIP/Postal Code
68005
Country
United States
Facility Name
Hisamitsu Investigator Site
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68510
Country
United States
Facility Name
Hisamitsu Investigator Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Hisamitsu Investigator Site
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Facility Name
Hisamitsu Investigator Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Hisamitsu Investigator Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
Hisamitsu Investigator Site
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45432
Country
United States
Facility Name
Hisamitsu Investigator Site
City
El Paso
State/Province
Texas
ZIP/Postal Code
79902
Country
United States
Facility Name
Hisamitsu Investigator Site
City
Grapevine
State/Province
Texas
ZIP/Postal Code
76051
Country
United States

12. IPD Sharing Statement

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

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