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

Information source: Hisamitsu Pharmaceutical Co., Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Ankle Sprain

Intervention: FS-67 Patch (Drug); Placebo Patch (Other)

Phase: Phase 4

Status: Completed

Sponsored by: Hisamitsu Pharmaceutical Co., Inc.

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).

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

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

Secondary outcome: SPID8 at rest; PID8; SPID12, SPID20, SPID44, and SPID68 at rest and upon monopodal weight bearing.

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

Eligibility

Minimum age: 13 Years. Maximum age: 17 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Grade 1 or Grade 2 ankle sprain

Exclusion Criteria:

- Pregnancy or lactation

Locations and Contacts

Hisamitsu Investigator Site, Birmingham, Alabama 35209, United States

Hisamitsu Investigator Site, Tucson, Arizona 85705, United States

Hisamitsu Investigator Site, Tucson, Arizona 85712, United States

Hisamitsu Investigator Site, Hot Springs, Arkansas 71913, United States

Hisamitsu Investigator Site, Anaheim, California 92804, United States

Hisamitsu Investigator Site, Bell Gardens, California 90201, United States

Hisamitsu Investigator Site, Long Beach, California 90806, United States

Hisamitsu Investigator Site, Los Angeles, California 90036, United States

Hisamitsu Investigator Site, Boynton Beach, Florida 33472, United States

Hisamitsu Investigator Site, Daytona Beach, Florida 32117, United States

Hisamitsu Investigator Site, Doral, Florida 33166, United States

Hisamitsu Investigator Site, Jacksonville, Florida 32216, United States

Hisamitsu Investigator Site, Evansville, Indiana 47714, United States

Hisamitsu Investigator Site, Topeka, Kansas 66604, United States

Hisamitsu Investigator Site, Bellevue, Nebraska 68005, United States

Hisamitsu Investigator Site, Lincoln, Nebraska 68510, United States

Hisamitsu Investigator Site, Las Vegas, Nevada 89106, United States

Hisamitsu Investigator Site, Berlin, New Jersey 08009, United States

Hisamitsu Investigator Site, Charlotte, North Carolina 28207, United States

Hisamitsu Investigator Site, Columbus, Ohio 43214, United States

Hisamitsu Investigator Site, Dayton, Ohio 45432, United States

Hisamitsu Investigator Site, El Paso, Texas 79902, United States

Hisamitsu Investigator Site, Grapevine, Texas 76051, United States

Additional Information

Starting date: December 2009
Last updated: May 12, 2015

Page last updated: August 23, 2015

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