Ankle Sprain
Conditions
Keywords
Ankle Sprain
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
Interventions
DRUGKetoprofen Patch
Two Ketoprofen HKT-500 patches applied to target ankle once daily for 14 days
OTHERPlacebo Patch
Two placebo patches placed on target ankle once daily for 14 days
Sponsors
Hisamitsu Pharmaceutical Co., Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed