HKT-500 in the Treatment of Adult Patients With Ankle Sprain
- Registration Number
- NCT00927641
- Lead Sponsor
- Hisamitsu Pharmaceutical Co., Inc.
- Brief Summary
The objective of this study is to demonstrate the multiple-dose efficacy and safety of HKT-500 for the treatment of ankle sprain.
- Detailed 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 240
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ketoprofen Patch (HKT-500) Ketoprofen Patch Two Ketoprofen HKT-500 patches applied to target ankle once daily for 14 days Placebo Patch Placebo Patch Two placebo patches placed on target ankle once daily for 14 days
- Primary Outcome Measures
Name Time Method Change from the baseline of the 100-mm VAS pain intensity score during monopodal weight bearing for 1 second at Visit 3 (Day 3 + 1 day) 3 days + 1
- Secondary Outcome Measures
Name Time Method Assessment of the subject's VAS pain intensity during monopodal weight bearing, at rest and in motion, summed pain intensity difference at rest and in motion, cumulative effect of pain reduction 14 days
Trial Locations
- Locations (1)
Hisamitsu Investigator Site
🇺🇸Danville, Virginia, United States