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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01037816
Recruitment Status : Completed
First Posted : December 23, 2009
Last Update Posted : June 4, 2015
Sponsor:
Information provided by (Responsible Party):
Hisamitsu Pharmaceutical Co., Inc.

Study Description
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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
Ankle Sprain 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
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Study Type : Interventional  (Clinical Trial)
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 : December 2009
Actual Primary Completion Date : November 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Capsaicin

Arms and Interventions
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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 Name: 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 Name: Sham treatment


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

Secondary Outcome Measures :
  1. SPID8 at rest; PID8; SPID12, SPID20, SPID44, and SPID68 at rest and upon monopodal weight bearing. [ Time Frame: 3 days ]

Eligibility Criteria
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Ages Eligible for Study:   13 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Grade 1 or Grade 2 ankle sprain

Exclusion Criteria:

  • Pregnancy or lactation
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01037816


Locations
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United States, Alabama
Hisamitsu Investigator Site
Birmingham, Alabama, United States, 35209
United States, Arizona
Hisamitsu Investigator Site
Tucson, Arizona, United States, 85705
Hisamitsu Investigator Site
Tucson, Arizona, United States, 85712
United States, Arkansas
Hisamitsu Investigator Site
Hot Springs, Arkansas, United States, 71913
United States, California
Hisamitsu Investigator Site
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
United States, Florida
Hisamitsu Investigator Site
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
United States, Indiana
Hisamitsu Investigator Site
Evansville, Indiana, United States, 47714
United States, Kansas
Hisamitsu Investigator Site
Topeka, Kansas, United States, 66604
United States, Nebraska
Hisamitsu Investigator Site
Bellevue, Nebraska, United States, 68005
Hisamitsu Investigator Site
Lincoln, Nebraska, United States, 68510
United States, Nevada
Hisamitsu Investigator Site
Las Vegas, Nevada, United States, 89106
United States, New Jersey
Hisamitsu Investigator Site
Berlin, New Jersey, United States, 08009
United States, North Carolina
Hisamitsu Investigator Site
Charlotte, North Carolina, United States, 28207
United States, Ohio
Hisamitsu Investigator Site
Columbus, Ohio, United States, 43214
Hisamitsu Investigator Site
Dayton, Ohio, United States, 45432
United States, Texas
Hisamitsu Investigator Site
El Paso, Texas, United States, 79902
Hisamitsu Investigator Site
Grapevine, Texas, United States, 76051
Sponsors and Collaborators
Hisamitsu Pharmaceutical Co., Inc.
More Information
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Responsible Party: Hisamitsu Pharmaceutical Co., Inc.
ClinicalTrials.gov Identifier: NCT01037816    
Other Study ID Numbers: FS-67-HP01-E02
First Posted: December 23, 2009    Key Record Dates
Last Update Posted: June 4, 2015
Last Verified: May 2015
Keywords provided by Hisamitsu Pharmaceutical Co., Inc.:
Ankle Sprain
Additional relevant MeSH terms:
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Sprains and Strains
Ankle Injuries
Wounds and Injuries
Leg Injuries
Capsaicin
 Antipruritics
Dermatologic Agents
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs