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

Sponsor:	Hisamitsu Pharmaceutical Co., Inc.
Information provided by:	Hisamitsu Pharmaceutical Co., Inc.
ClinicalTrials.gov Identifier:	NCT01037816

Purpose

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 IV

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:

Drug Information available for: Capsaicin

U.S. FDA Resources

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 ]

Estimated Enrollment:	300
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)

Eligibility

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

Criteria

Inclusion Criteria:

Grade 1 or Grade 2 ankle sprain

Exclusion Criteria:

Pregnancy or lactation

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01037816

Locations

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 (Mr. Yoshinobu Higashi), Hisamitsu Pharmaceutical Co., Inc.
ClinicalTrials.gov Identifier:	NCT01037816 History of Changes
Other Study ID Numbers:	FS-67-HP01-E02
Study First Received:	December 18, 2009
Last Updated:	February 9, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Hisamitsu Pharmaceutical Co., Inc.:

Ankle Sprain

Additional relevant MeSH terms:

Sprains and Strains
Ankle Injuries
Wounds and Injuries
Leg Injuries
Capsaicin
Sensory System Agents

Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Antipruritics
Dermatologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012