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

This study has been completed.
Information provided by (Responsible Party):
Hisamitsu Pharmaceutical Co., Inc. Identifier:
First received: December 18, 2009
Last updated: August 18, 2014
Last verified: August 2014

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 Intervention Phase
Ankle Sprain
Drug: FS-67
Other: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

Further study details as provided by Hisamitsu Pharmaceutical Co., Inc.:

Primary Outcome Measures:
  • Primary: Sum of Pain Intensity Difference at 8-hours (SPID8) upon monopodal weight bearing. [ Time Frame: 8 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • SPID8 at rest; PID8; SPID12, SPID20, SPID44, and SPID68 at rest and upon monopodal weight bearing. [ Time Frame: 3 days ] [ Designated as safety issue: No ]

Enrollment: 252
Study Start Date: December 2009
Study Completion Date: December 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: FS-67 Drug: FS-67
One FS-67 patch applied to target ankle every 12 hours for three days (up to 6 FS-67 patches in three days)
Placebo Comparator: Placebo Other: Placebo
One placebo patch applied to target ankle every 12 hours for three days (up to 6 FS-67 patches in three days)


Ages Eligible for Study:   13 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Grade 1 or Grade 2 ankle sprain

Exclusion Criteria:

  • Pregnancy or lactation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01037816

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

No publications provided

Responsible Party: Hisamitsu Pharmaceutical Co., Inc. Identifier: NCT01037816     History of Changes
Other Study ID Numbers: FS-67-HP01-E02
Study First Received: December 18, 2009
Last Updated: August 18, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Hisamitsu Pharmaceutical Co., Inc.:
Ankle Sprain

Additional relevant MeSH terms:
Ankle Injuries
Leg Injuries
Wounds and Injuries
Dermatologic Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses processed this record on November 25, 2014