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

Hisamitsu Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Ankle Sprain

Treatments: Other: Placebo Patch; Drug: Ketoprofen Patch

Study type: Interventional

Funder types: Industry

Identifiers

NCT00927641

HKT-500-US17

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

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

Enrollment: 240 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

240 participants in 2 patient groups, including a placebo group

Ketoprofen Patch (HKT-500)

Active Comparator group

Description:

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

Treatment:

Drug: Ketoprofen Patch

Placebo Patch

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo Patch