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

May 12, 2015 updated by: Hisamitsu Pharmaceutical Co., Inc.

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

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

Intervention / Treatment

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

Enrollment (Actual)

240

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35290
        • Hisamitsu Investigator Site
    • Arizona
      • Phoenix, Arizona, United States, 85050
        • Hisamitsu Investigator Site
      • Tucson, Arizona, United States, 85712
        • Hisamitsu Investigator Site
    • Arkansas
      • Hot Springs, Arkansas, United States, 71913
        • Hisamitsu Investigator Site
    • California
      • Anaheim, California, United States, 92804
        • Hisamitsu Investigator Site
      • Anaheim, California, United States, 92801
        • 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
        • Hisamitsu Investigator Site
    • Florida
      • 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
        • Hisamitsu Investigator Site
    • Indiana
      • Evansville, Indiana, United States, 47714
        • Hisamitsu Investigator Site
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Hisamitsu Investigator Site
    • New Jersey
      • Blackwood, New Jersey, United States, 08012
        • Hisamitsu Investigator Site
      • South Bound Brook, New Jersey, United States, 08880
        • Hisamitsu Investigator Site
    • Tennessee
      • Johnson City, Tennessee, United States, 37604
        • Hisamitsu Investigator Site
    • Texas
      • Dallas, Texas, United States, 75243
        • Hisamitsu Investigator Site
    • Utah
      • West Valley City, Utah, United States, 84120
        • Hisamitsu Investigator Site
    • Virginia
      • Danville, Virginia, United States, 24541
        • Hisamitsu Investigator Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Sham treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
3 days + 1

Secondary Outcome Measures

Outcome Measure
Time Frame
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
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hisamitsu Pharmaceutical Co., Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

June 24, 2009

First Submitted That Met QC Criteria

June 24, 2009

First Posted (Estimate)

June 25, 2009

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HKT-500-US17

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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