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

Hisamitsu Pharmaceutical Co., Inc.240 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

240

Conditions

Ankle Sprain

Interventions

Ketoprofen PatchDRUG

Two Ketoprofen HKT-500 patches applied to target ankle once daily for 14 days

Placebo PatchOTHER

Two placebo patches placed on target ankle once daily for 14 days

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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 Outcomes

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

Data from ClinicalTrials.gov

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