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

This study has been completed.
Information provided by (Responsible Party):
Hisamitsu Pharmaceutical Co., Inc. Identifier:
First received: June 24, 2009
Last updated: January 12, 2015
Last verified: January 2015

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

Condition Intervention Phase
Ankle Sprain
Drug: ketoprofen
Other: Placebo
Phase 3

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, 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

Resource links provided by NLM:

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

Primary Outcome Measures:
  • 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) [ Time Frame: 3 days + 1 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Enrollment: 240
Study Start Date: July 2009
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: HKT-500 Drug: ketoprofen
Two HKT-500 patches applied to target ankle once daily for 14 days
Placebo Comparator: Placebo Other: Placebo
Two placebo patched placed on target ankle once daily for 14 days


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  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: NCT00927641

United States, Alabama
Hisamitsu Investigator Site
Birmingham, Alabama, United States, 35290
United States, Arizona
Hisamitsu Investigator Site
Phoenix, Arizona, United States, 85050
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, 92801
Hisamitsu Investigator Site
Anaheim, California, United States, 92804
Hisamitsu Investigator Site
Buena Park, California, United States, 90620
Hisamitsu Investigator Site
Long Beach, California, United States, 90813
Hisamitsu Investigator Site
San Diego, California, United States, 92120
Hisamitsu Investigator Site
San Luis Obispo, California, United States, 93405
United States, Florida
Hisamitsu Investigator Site
Daytona Beach, Florida, United States, 32117
Hisamitsu Investigator Site
Hialeah, Florida, United States, 33013
Hisamitsu Investigator Site
Jacksonville, Florida, United States, 32216
Hisamitsu Investigator Site
Lauderdale Lakes, Florida, United States, 33319
Hisamitsu Investigator Site
Oldsmar, Florida, United States, 34677
Hisamitsu Investigator Site
Ormond Beach, Florida, United States, 32174
Hisamitsu Investigator Site
South Miami, Florida, United States, 33143
United States, Indiana
Hisamitsu Investigator Site
Evansville, Indiana, United States, 47714
United States, Nebraska
Hisamitsu Investigator Site
Omaha, Nebraska, United States, 68114
United States, New Jersey
Hisamitsu Investigator Site
Blackwood, New Jersey, United States, 08012
Hisamitsu Investigator Site
South Bound Brook, New Jersey, United States, 08880
United States, Tennessee
Hisamitsu Investigator Site
Johnson City, Tennessee, United States, 37604
United States, Texas
Hisamitsu Investigator Site
Dallas, Texas, United States, 75243
United States, Utah
Hisamitsu Investigator Site
West Valley City, Utah, United States, 84120
United States, Virginia
Hisamitsu Investigator Site
Danville, Virginia, United States, 24541
Sponsors and Collaborators
Hisamitsu Pharmaceutical Co., Inc.
  More Information

No publications provided

Responsible Party: Hisamitsu Pharmaceutical Co., Inc. Identifier: NCT00927641     History of Changes
Other Study ID Numbers: HKT-500-US17
Study First Received: June 24, 2009
Last Updated: January 12, 2015
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 processed this record on May 29, 2015