HKT-500 in Adult Patients With Shoulder Pain

Hisamitsu Pharmaceutical Co., Inc.368 enrolled

Overview

The objective of this study is to determine the efficacy of HKT-500 in subjects with acute shoulder pain

Randomized, double-blind, placebo-controlled, multicenter study in men and women 18 years of age or greater who have acute shoulder pain requiring analgesic treatment daily for at least 2 weeks.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

368

Conditions

Pain

Interventions

HKT-500 Ketoprofen Topical PatchDRUG

HKT-500 Ketoprofen Topical Patch

Placebo PatchOTHER

Treatment with Placebo Patch

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * The subject has unilateral acute shoulder pain. Exclusion Criteria: * The subject is a women of childbearing potential who has a positive urine pregnancy test, or who is lactating, or who is not surgically sterile (by tubal ligation or hysterectomy), or at least 2 years postmenopausal, and 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 (35)

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

Tempe, Arizona, United States

Hisamitsu Investigator Site

Fullerton, California, United States

Hisamitsu Investigator Site

Denver, Colorado, United States

Hisamitsu Investigator Site

Washington D.C., District of Columbia, United States

Hisamitsu Investigator Site

Bradenton, Florida, United States

Hisamitsu Investigator Site

Chiefland, Florida, United States

Hisamitsu Investigator Site

DeLand, Florida, United States

Hisamitsu Investigator Site

Delray Beach, Florida, United States

Hisamitsu Investigator Site

Dunedin, Florida, United States

...and 25 more locations