Clinical trial NCT01037816: FS-67 in the Treatment of Pediatric Patients With Ankle Sprain
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ankle Sprain
Keywords: Ankle Sprain
Lead sponsor: Hisamitsu Pharmaceutical Co., Inc.
Sponsor class: INDUSTRY
First posted: 2009-12-23
Enrollment: 252
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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 criteria: Inclusion Criteria:

* Grade 1 or Grade 2 ankle sprain

Exclusion Criteria:

* Pregnancy or lactation

Primary outcomes:
measure: Primary: Sum of Pain Intensity Difference (SPID) at 8-hours (SPID8) Upon Monopodal Weight Bearing.
timeFrame: 8 hours of patch application on Day 1
Secondary outcomes:
measure: Sum of Pain Intensity Difference at 8-hours (SPID8) at Rest.
timeFrame: 8 hours of patch application on Day 1
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Hisamitsu Investigator Site
state: Alabama
city: Tucson
country: United States
facility: Hisamitsu Investigator Site
state: Arizona
city: Tucson
country: United States
facility: Hisamitsu Investigator Site
state: Arizona
city: Hot Springs
country: United States
facility: Hisamitsu Investigator Site
state: Arkansas
city: Anaheim
country: United States
facility: Hisamitsu Investigator Site
state: California
city: Bell Gardens
country: United States
facility: Hisamitsu Investigator Site
state: California
city: Long Beach
country: United States
facility: Hisamitsu Investigator Site
state: California
city: Los Angeles
country: United States
facility: Hisamitsu Investigator Site
state: California
city: Boynton Beach
country: United States
facility: Hisamitsu Investigator Site
state: Florida
city: Daytona Beach
country: United States
facility: Hisamitsu Investigator Site
state: Florida
city: Doral
country: United States
facility: Hisamitsu Investigator Site
state: Florida
city: Jacksonville
country: United States
facility: Hisamitsu Investigator Site
state: Florida
city: Evansville
country: United States
facility: Hisamitsu Investigator Site
state: Indiana
city: Topeka
country: United States
facility: Hisamitsu Investigator Site
state: Kansas
city: Bellevue
country: United States
facility: Hisamitsu Investigator Site
state: Nebraska
city: Lincoln
country: United States
facility: Hisamitsu Investigator Site
state: Nebraska
city: Las Vegas
country: United States
facility: Hisamitsu Investigator Site
state: Nevada
city: Berlin
country: United States
facility: Hisamitsu Investigator Site
state: New Jersey
city: Charlotte
country: United States
facility: Hisamitsu Investigator Site
state: North Carolina
city: Columbus
country: United States
facility: Hisamitsu Investigator Site
state: Ohio
city: Dayton
country: United States
facility: Hisamitsu Investigator Site
state: Ohio
city: El Paso
country: United States
facility: Hisamitsu Investigator Site
state: Texas
city: Grapevine
country: United States
facility: Hisamitsu Investigator Site
state: Texas
Study officials:
affiliation: Hisamitsu Pharmaceutical Co., Inc.
name: Yoshinobu Higashi
role: STUDY_DIRECTOR
References: