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

Sponsor
Hisamitsu Pharmaceutical Co., Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01037816
Collaborator
(none)
252
Enrollment
23
Locations
2
Arms
12
Duration (Months)
11
Patients Per Site
0.9
Patients Per Site Per Month

Study Details

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).

Condition or Disease Intervention/Treatment Phase
  • Drug: FS-67 Patch
  • Other: Placebo Patch
 Phase 4

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 Design

Study Type:
Interventional
Actual Enrollment :
252 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
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 Start Date :
Dec 1, 2009
Actual Primary Completion Date :
Nov 1, 2010
Actual Study Completion Date :
Dec 1, 2010

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Primary: Sum of Pain Intensity Difference at 8-hours (SPID8) upon monopodal weight bearing. [8 hours]

    Secondary Outcome Measures

    1. SPID8 at rest; PID8; SPID12, SPID20, SPID44, and SPID68 at rest and upon monopodal weight bearing. [3 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    13 Years to 17 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Grade 1 or Grade 2 ankle sprain
    Exclusion Criteria:
    • Pregnancy or lactation

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hisamitsu Investigator Site Birmingham Alabama United States 35209
    2 Hisamitsu Investigator Site Tucson Arizona United States 85705
    3 Hisamitsu Investigator Site Tucson Arizona United States 85712
    4 Hisamitsu Investigator Site Hot Springs Arkansas United States 71913
    5 Hisamitsu Investigator Site Anaheim California United States 92804
    6 Hisamitsu Investigator Site Bell Gardens California United States 90201
    7 Hisamitsu Investigator Site Long Beach California United States 90806
    8 Hisamitsu Investigator Site Los Angeles California United States 90036
    9 Hisamitsu Investigator Site Boynton Beach Florida United States 33472
    10 Hisamitsu Investigator Site Daytona Beach Florida United States 32117
    11 Hisamitsu Investigator Site Doral Florida United States 33166
    12 Hisamitsu Investigator Site Jacksonville Florida United States 32216
    13 Hisamitsu Investigator Site Evansville Indiana United States 47714
    14 Hisamitsu Investigator Site Topeka Kansas United States 66604
    15 Hisamitsu Investigator Site Bellevue Nebraska United States 68005
    16 Hisamitsu Investigator Site Lincoln Nebraska United States 68510
    17 Hisamitsu Investigator Site Las Vegas Nevada United States 89106
    18 Hisamitsu Investigator Site Berlin New Jersey United States 08009
    19 Hisamitsu Investigator Site Charlotte North Carolina United States 28207
    20 Hisamitsu Investigator Site Columbus Ohio United States 43214
    21 Hisamitsu Investigator Site Dayton Ohio United States 45432
    22 Hisamitsu Investigator Site El Paso Texas United States 79902
    23 Hisamitsu Investigator Site Grapevine Texas United States 76051

    Sponsors and Collaborators

    • Hisamitsu Pharmaceutical Co., Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hisamitsu Pharmaceutical Co., Inc.
    ClinicalTrials.gov Identifier:
    NCT01037816
    Other Study ID Numbers:
    • FS-67-HP01-E02
    First Posted:
    Dec 23, 2009
    Last Update Posted:
    Jun 4, 2015
    Last Verified:
    May 1, 2015
    Keywords provided by Hisamitsu Pharmaceutical Co., Inc.
    Ankle Sprain
    Additional relevant MeSH terms:
    Sprains and Strains
    Ankle Injuries

    Study Results

    No Results Posted as of Jun 4, 2015