ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00927641
Recruitment Status : Completed
First Posted : June 25, 2009
Last Update Posted : June 4, 2015
Sponsor:
Information provided by (Responsible Party):
Hisamitsu Pharmaceutical Co., Inc.

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

Condition or disease Intervention/treatment Phase
Ankle Sprain Drug: Ketoprofen Patch Other: Placebo Patch Phase 3

Detailed 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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : July 2009
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Ketoprofen
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Ketoprofen Patch (HKT-500)
Two Ketoprofen HKT-500 patches applied to target ankle once daily for 14 days
Drug: Ketoprofen Patch
Two Ketoprofen HKT-500 patches applied to target ankle once daily for 14 days
Other Name: Topical Patch
Placebo Comparator: Placebo Patch
Two placebo patches placed on target ankle once daily for 14 days
Other: Placebo Patch
Two placebo patches placed on target ankle once daily for 14 days
Other Name: Sham treatment



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00927641


Locations
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.

Responsible Party: Hisamitsu Pharmaceutical Co., Inc.
ClinicalTrials.gov Identifier: NCT00927641     History of Changes
Other Study ID Numbers: HKT-500-US17
First Posted: June 25, 2009    Key Record Dates
Last Update Posted: June 4, 2015
Last Verified: May 2015

Keywords provided by Hisamitsu Pharmaceutical Co., Inc.:
Ankle Sprain

Additional relevant MeSH terms:
Sprains and Strains
Ankle Injuries
Wounds and Injuries
Leg Injuries
Ketoprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action