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

Sponsored by:	Hisamitsu Pharmaceutical Co., Inc.
Information provided by:	Hisamitsu Pharmaceutical Co., Inc.
ClinicalTrials.gov Identifier:	NCT00927641

Purpose

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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:

Drug Information available for: Ketoprofen

U.S. FDA Resources

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 ]

Estimated Enrollment:	230
Study Start Date:	July 2009
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
HKT-500: Active Comparator	Drug: ketoprofen Two HKT-500 patches applied to target ankle once daily for 14 days
Placebo: Placebo Comparator	Other: Placebo Two placebo patched placed on target ankle once daily for 14 days

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00927641

Contacts

Contact: Hisamitsu Investigator

HKTUS17@hisamitsupharm.com

Locations

United States, Alabama
Hisamitsu Investigator Site	Recruiting
Birmingham, Alabama, United States, 35290
Contact HKTUS17@hisamitsupharm.com
United States, Arizona
Hisamitsu Investigator Site	Recruiting
Phoenix, Arizona, United States, 85050
Contact HKTUS17@hisamitsupharm.com
Hisamitsu Investigator Site	Recruiting
Tucson, Arizona, United States, 85712
Contact HKTUS17@hisamitsupharm.com
United States, Arkansas
Hisamitsu Investigator Site	Recruiting
Hot Springs, Arkansas, United States, 71913
Contact HKTUS17@hisamitsupharm.com
United States, California
Hisamitsu Investigator Site	Recruiting
Anaheim, California, United States, 92801
Contact HKTUS17@hisamitsupharm.com
Hisamitsu Investigator Site	Recruiting
Anaheim, California, United States, 92804
Contact HKTUS17@hisamitsupharm.com
Hisamitsu Investigator Site	Recruiting
Buena Park, California, United States, 90620
Contact HKTUS17@hisamitsupharm.com
Hisamitsu Investigator Site	Recruiting
Long Beach, California, United States, 90813
Contact HKTUS17@hisamitsupharm.com
Hisamitsu Investigator Site	Recruiting
San Diego, California, United States, 92120
Contact HKTUS17@hisamitsupharm.com
Hisamitsu Investigator Site	Recruiting
San Luis Obispo, California, United States, 93405
Contact HKTUS17@hisamitsupharm.com
United States, Florida
Hisamitsu Investigator Site	Recruiting
Daytona Beach, Florida, United States, 32117
Contact HKTUS17@hisamitsupharm.com
Hisamitsu Investigator Site	Recruiting
Hialeah, Florida, United States, 33013
Contact HKTUS17@hisamitsupharm.com
Hisamitsu Investigator Site	Recruiting
Jacksonville, Florida, United States, 32216
Contact HKTUS17@hisamitsupharm.com
Hisamitsu Investigator Site	Recruiting
Lauderdale Lakes, Florida, United States, 33319
Contact HKTUS17@hisamitsupharm.com
Hisamitsu Investigator Site	Recruiting
Oldsmar, Florida, United States, 34677
Contact HKTUS17@hisamitsupharm.com
Hisamitsu Investigator Site	Recruiting
Ormond Beach, Florida, United States, 32174
Contact HKTUS17@hisamitsupharm.com
Hisamitsu Investigator Site	Recruiting
South Miami, Florida, United States, 33143
Contact HKTUS17@hisamitsupharm.com
United States, Indiana
Hisamitsu Investigator Site	Recruiting
Evansville, Indiana, United States, 47714
Contact HKTUS17@hisamitsupharm.com
United States, Nebraska
Hisamitsu Investigator Site	Recruiting
Omaha, Nebraska, United States, 68114
Contact HKTUS17@hisamitsupharm.com
United States, New Jersey
Hisamitsu Investigator Site	Recruiting
Blackwood, New Jersey, United States, 08012
Contact HKTUS17@hisamitsupharm.com
Hisamitsu Investigator Site	Recruiting
South Bound Brook, New Jersey, United States, 08880
Contact HKTUS17@hisamitsupharm.com
United States, Tennessee
Hisamitsu Investigator Site	Recruiting
Johnson City, Tennessee, United States, 37604
Contact HKTUS17@hisamitsupharm.com
United States, Texas
Hisamitsu Investigator Site	Recruiting
Dallas, Texas, United States, 75243
Contact HKTUS17@hisamitsupharm.com
United States, Utah
Hisamitsu Investigator Site	Recruiting
West Valley City, Utah, United States, 84120
Contact HKTUS17@hisamitsupharm.com
United States, Virginia
Hisamitsu Investigator Site	Recruiting
Danville, Virginia, United States, 24541
Contact HKTUS17@hisamitsupharm.com

Sponsors and Collaborators

Hisamitsu Pharmaceutical Co., Inc.

More Information

No publications provided

Responsible Party:	Hisamitsu Pharmaceutical Co., Inc ( Mr. Kenichi Furuta )
Study ID Numbers:	HKT-500-US17
Study First Received:	June 24, 2009
Last Updated:	July 24, 2009
ClinicalTrials.gov Identifier:	NCT00927641 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Hisamitsu Pharmaceutical Co., Inc.:

Ankle Sprain

Study placed in the following topic categories:

Anti-Inflammatory Agents
Ketoprofen
Analgesics, Non-Narcotic
Cyclooxygenase Inhibitors
Wounds and Injuries
Disorders of Environmental Origin

Anti-Inflammatory Agents, Non-Steroidal
Pain
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Sprains and Strains

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Ketoprofen
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase Inhibitors
Physiological Effects of Drugs
Wounds and Injuries
Disorders of Environmental Origin
Enzyme Inhibitors
Pharmacologic Actions

Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents
Sprains and Strains

ClinicalTrials.gov processed this record on September 09, 2009