HKT-500 in Adult Patients With Ankle Sprain

Hisamitsu Pharmaceutical Co., Inc.260 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.

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

Allocation

RANDOMIZED

Masking

QUADRUPLE

Enrollment

260

Conditions

Ankle Sprain

Interventions

HKT-500 Ketoprofen Topical PatchDRUG

HKT-500 Ketoprofen Topical Patch

Placebo PatchOTHER

Placebo Patch

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (30)

Outcomes

Primary Outcomes

Pain Assessment

Time frame: 2 Weeks

Secondary Outcomes

Safety Assessment

Time frame: 2 Weeks

Data from ClinicalTrials.gov

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Hisamitsu Investigator Site.

Birmingham, Alabama, United States

Hisamitsu Investigator Site.

Birmingham, Alabama, United States

Hisamitsu Investigator Site.

Montgomery, Alabama, United States

Hisamitsu Investigator Site.

Anaheim, California, United States

Hisamitsu Investigator Site.

San Luis Obispo, California, United States

Hisamitsu Investigator Site.

Colorado Springs, Colorado, United States

Hisamitsu Investigator Site.

Kissimmee, Florida, United States

Hisamitsu Investigator Site.

Oldsmar, Florida, United States

Hisamitsu Investigator Site.

Pembroke Pines, Florida, United States

Hisamitsu Investigator Site.

South Miami, Florida, United States

...and 20 more locations