HKT-500 in Adult Patients With Ankle Sprain

Hisamitsu Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Ankle Sprain

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00680784

HKT-500-US10

Details and patient eligibility

About

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

Full description

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.

Enrollment: 260 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

260 participants in 2 patient groups, including a placebo group

HKT-500 Ketoprofen Topical Patch

Experimental group

Description:

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.

Treatment:

Drug: HKT-500 Ketoprofen Topical Patch

Placebo Patch

Placebo Comparator group

Description:

Treatment with placebo patch

Treatment:

Other: Placebo Patch