HKT-500 in the Treatment of Adult Patients With Ankle Sprain

Ankle Sprain Clinical Trial

Official title:

A Randomized, Multicenter, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of HKT-500 in the Treatment of Pain Associated With Mild to Moderate Ankle Sprain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00927641
• Other study ID #: HKT-500-US17
• Status: Completed
• Phase: Phase 3
• First received: June 24, 2009
• Last updated: May 12, 2015
• Start date: July 2009
• Est. completion date: November 2010

Study information

• Verified date: May 2015
• Source: Hisamitsu Pharmaceutical Co., Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to demonstrate the multiple-dose efficacy and safety of HKT-500 for the treatment of ankle sprain.

Description:

A Randomized, Multicenter, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of HKT-500 in the Treatment of Pain Associated With Mild to Moderate Ankle Sprain

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• mild to Moderate Ankle Sprain

Exclusion Criteria:

• Any women of childbearing potential who has a positive urine pregnancy test, who is lactating, who is not surgically sterile (by tubal ligation or hysterectomy), who is not at least 2 years postmenopausal, or has not practiced an acceptable form of birth control (defined as the use of an intrauterine device with spermicide, a barrier method with spermicide, condoms with spermicide, subdermal implant, oral contraceptives, or abstinence) for at least 2 months prior to Visit 1.

Study Design

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

Related Conditions & MeSH terms

• Ankle Injuries
• Ankle Sprain

Intervention

Drug:
• Ketoprofen Patch
Two Ketoprofen HKT-500 patches applied to target ankle once daily for 14 days

Other:
• Placebo Patch
Two placebo patches placed on target ankle once daily for 14 days

Locations

Country	Name	City	State
United States	Hisamitsu Investigator Site	Anaheim	California
United States	Hisamitsu Investigator Site	Anaheim	California
United States	Hisamitsu Investigator Site	Birmingham	Alabama
United States	Hisamitsu Investigator Site	Blackwood	New Jersey
United States	Hisamitsu Investigator Site	Buena Park	California
United States	Hisamitsu Investigator Site	Dallas	Texas
United States	Hisamitsu Investigator Site	Danville	Virginia
United States	Hisamitsu Investigator Site	Daytona Beach	Florida
United States	Hisamitsu Investigator Site	Evansville	Indiana
United States	Hisamitsu Investigator Site	Hialeah	Florida
United States	Hisamitsu Investigator Site	Hot Springs	Arkansas
United States	Hisamitsu Investigator Site	Jacksonville	Florida
United States	Hisamitsu Investigator Site	Johnson City	Tennessee
United States	Hisamitsu Investigator Site	Lauderdale Lakes	Florida
United States	Hisamitsu Investigator Site	Long Beach	California
United States	Hisamitsu Investigator Site	Oldsmar	Florida
United States	Hisamitsu Investigator Site	Omaha	Nebraska
United States	Hisamitsu Investigator Site	Ormond Beach	Florida
United States	Hisamitsu Investigator Site	Phoenix	Arizona
United States	Hisamitsu Investigator Site	San Diego	California
United States	Hisamitsu Investigator Site	San Luis Obispo	California
United States	Hisamitsu Investigator Site	South Bound Brook	New Jersey
United States	Hisamitsu Investigator Site	South Miami	Florida
United States	Hisamitsu Investigator Site	Tucson	Arizona
United States	Hisamitsu Investigator Site	West Valley City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Hisamitsu Pharmaceutical Co., Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from the baseline of the 100-mm VAS pain intensity score during monopodal weight bearing for 1 second at Visit 3 (Day 3 + 1 day)		3 days + 1	No
Secondary	Assessment of the subject's VAS pain intensity during monopodal weight bearing, at rest and in motion, summed pain intensity difference at rest and in motion, cumulative effect of pain reduction		14 days	No