HKT-500 in Adult Patients With Shoulder Pain

Hisamitsu Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Pain

Treatments: Drug: HKT-500 Ketoprofen Topical Patch; Other: Placebo Patch

Study type: Interventional

Funder types: Industry

Identifiers

NCT00680472

HKT-500-US08

Details and patient eligibility

About

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

Full description

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.

Enrollment: 368 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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368 participants in 2 patient groups, including a placebo group

A,1 HKT-500 Ketoprofen Topical Patch

Active Comparator group

Description:

A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Two-Week Study to Assess the Efficacy and Safety of HKT-500 in Subjects with Acute Shoulder Pain

Treatment:

Drug: HKT-500 Ketoprofen Topical Patch

A,2 Placebo Patch

Placebo Comparator group

Description:

Treatment with placebo patch

Treatment:

Other: Placebo Patch