HKT-500 in Adult Patients With Ankle Sprain

Protocol HKT-500-US10: A Randomized, Multicenter, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of HKT-500 in the Treatment of Pain Associated With Grade I or Grade II Ankle Sprain

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

Study Overview

• Status: Completed
• Conditions: Ankle Sprain
• Intervention / Treatment: Drug: HKT-500 Ketoprofen Topical Patch; Other: Placebo Patch

Detailed Description

Randomized, double-blind, placebo-controlled, multicenter study in men and women 18 years of age or older who have a painful, acute, benign, ankle sprain of the lateral ligament(s) within the previous 48 hours.

• Study Type: Interventional
• Enrollment (Actual): 260
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35209
      • Hisamitsu Investigator Site.
    • Birmingham, Alabama, United States, 35234
      • Hisamitsu Investigator Site.
    • Montgomery, Alabama, United States, 36106
      • Hisamitsu Investigator Site.
  • California
    • Anaheim, California, United States, 92804
      • Hisamitsu Investigator Site.
    • San Luis Obispo, California, United States, 93405
      • Hisamitsu Investigator Site.
  • Colorado
    • Colorado Springs, Colorado, United States, 80909
      • Hisamitsu Investigator Site.
  • Florida
    • Kissimmee, Florida, United States, 34741
      • Hisamitsu Investigator Site.
    • Oldsmar, Florida, United States, 34677
      • Hisamitsu Investigator Site.
    • Pembroke Pines, Florida, United States, 33026
      • Hisamitsu Investigator Site.
    • South Miami, Florida, United States, 33143
      • Hisamitsu Investigator Site.
  • Georgia
    • Blue Ridge, Georgia, United States, 30513
      • Hisamitsu Investigator Site.
  • Illinois
    • Chicago, Illinois, United States, 60616
      • Hisamitsu Investigator Site.
  • Kentucky
    • Paducah, Kentucky, United States, 42003
      • Hisamitsu Investigator Site.
  • Maryland
    • Pasadena, Maryland, United States, 21122
      • Hisamitsu Investigator Site.
  • Michigan
    • Benzonia, Michigan, United States, 49616
      • Hisamitsu Investigator Site.
    • Cadillac, Michigan, United States, 49601
      • Hisamitsu Investigator Site.
    • Interlochen, Michigan, United States, 49643
      • Hisamitsu Investigator Site.
    • Kalamazoo, Michigan, United States, 49009
      • Hisamitsu Investigator Site.
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Hisamitsu Investigator Site.
  • New Jersey
    • South Bound Brook, New Jersey, United States, 08880
      • Hisamitsu Investigator Site.
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • Hisamitsu Investigator Site.
  • New York
    • New York, New York, United States, 10022
      • Hisamitsu Investigator Site.
  • North Dakota
    • Fargo, North Dakota, United States, 58103
      • Hisamitsu Investigator Site.
  • Ohio
    • Zanesville, Ohio, United States, 43701
      • Hisamitsu Investigator Site.
  • Pennsylvania
    • Altoona, Pennsylvania, United States, 16602
      • Hisamitsu Investigator Site.
    • Feasterville, Pennsylvania, United States, 19053
      • Hisamitsu Investigator Site.
    • Morrisville, Pennsylvania, United States, 19067
      • Hisamitsu Investigator Site.
    • Norristown, Pennsylvania, United States, 19401
      • Hisamitsu Investigator Site.
  • Texas
    • Houston, Texas, United States, 77074
      • Hisamitsu Investigator Site.
  • Washington
    • Bellevue, Washington, United States, 98004
      • Hisamitsu Investigator Site.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Grade I or Grade II Ankle Sprain.

Exclusion Criteria:

• The subject is a women of childbearing potential who has a positive urine pregnancy test, who is lactating, who is not surgically sterile (by tubal ligation or hysterectomy), or at least 2 years postmenopausal, and has not practice 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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HKT-500 Ketoprofen Topical Patch; Randomized, double-blind, placebo-controlled, multicenter study in men and women 18 years of age or older who have a painful, acute, benign, ankle sprain of the lateral ligament(s) within the previous 48 hours.	Drug: HKT-500 Ketoprofen Topical Patch; HKT-500 Ketoprofen Topical Patch; Other Names: Ketoprofen Topical Patch
Placebo Comparator: Placebo Patch; Treatment with placebo patch	Other: Placebo Patch; Placebo Patch; Other Names: Sham treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pain Assessment	2 Weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Safety Assessment	2 Weeks

Collaborators and Investigators

• Sponsor: Hisamitsu Pharmaceutical Co., Inc.

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (Actual): November 1, 2008
• Study Completion (Actual): November 1, 2008

Study Registration Dates

• First Submitted: May 16, 2008
• First Submitted That Met QC Criteria: May 19, 2008
• First Posted (Estimate): May 20, 2008

Study Record Updates

• Last Update Posted (Estimate): June 4, 2015
• Last Update Submitted That Met QC Criteria: May 12, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: pain; ankle; sprain
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Sprains and Strains; Ankle Injuries; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Ketoprofen
• Other Study ID Numbers: HKT-500-US10