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HKT-500 in the Treatment of Adult Patients With Ankle Sprain | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

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

NCT00927641•Hisamitsu Pharmaceutical Co., Inc.

View on ClinicalTrials.gov

Summary

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

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (25)

Hisamitsu Investigator Site

Birmingham, Alabama, United States

Hisamitsu Investigator Site

Phoenix, Arizona, United States

Hisamitsu Investigator Site

Tucson, Arizona, United States

Hisamitsu Investigator Site

Hot Springs, Arkansas, United States

Hisamitsu Investigator Site

Anaheim, California, United States

Hisamitsu Investigator Site

Anaheim, California, United States

Hisamitsu Investigator Site

Buena Park, California, United States

Hisamitsu Investigator Site

Long Beach, California, United States

Hisamitsu Investigator Site

San Diego, California, United States

Hisamitsu Investigator Site

San Luis Obispo, California, United States

Key Dates

Start Date

July 1, 2009

Primary Completion Date

November 1, 2010

Completion Date

November 1, 2010

Last Updated

June 4, 2015

Enrollment

240

ACTUAL participants

Conditions

Ankle Sprain

Interventions

Ketoprofen Patch

DRUG

Placebo Patch

OTHER

Auditory Biofeedback Gait Training Individuals With Chronic Ankle Instability

NCT06868316

Ankle SprainsAnkle Injuries and Disorders

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RECRUITING

Comparison of MBR + Suture Tape and MBR for CLAI in GJL Cases: A Prospective Cohort Study

NCT06897293

Ankle SprainHypermobility, Joint

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 4, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Auditory Biofeedback Gait Training Individuals With Chronic Ankle Instability

Comparison of MBR + Suture Tape and MBR for CLAI in GJL Cases: A Prospective Cohort Study

Arthroscopic Versus Open Brostrom for Ankle Instability

Design and Validation of a Mobile Health Application for Home-Based Musculoskeletal Therapy in Ankle Sprain

Topical Treatments for Ankle Sprains

Comparison of Anesthetic Techniques for Early Recovery After Ankle Arthroscopy