Acute Pain From Ankle Sprain or Strain
Conditions
Brief summary
This is a randomized, double blind, placebo controlled, parallel group study to assess the efficacy and safety of K-103-IP compared with placebo patch for treatment of mild to moderate acute pain associated with ankle strain or sprain.
Interventions
DRUGK-103-IP
DRUGPlacebo
Placebo comparator
Sponsors
Kowa Research Institute, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Subject must provide informed consent before any study specific evaluation is performed. * Subject is male or female aged 18 to 70 years, inclusive. * Subject has a grade 1 (mild functional impairment) or grade 2 (moderate functional impairment) ankle strain or sprain that occurred within 48 hours before the Screening visit. * Subject has pain intensity upon monopodal weight bearing of 5 to 8, inclusive, measured by an 11 point nominal rating scale (NRS), plus pain intensity score at rest that is less than upon monopodal weight bearing.
Exclusion criteria
* Subject has a grade 3 (severe functional impairment) strain or sprain, bilateral strain or sprain, or concomitant fracture or wound at the site of the strain or sprain. * Subject has had an ankle strain or sprain to the same foot within 6 months before the Screening visit. * Subject has received topical analgesic medication within 24 hours before the Screening visit. * Subject has applied ice or compression to the injured area within 2 hours before the Screening visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sum of Pain Intensity Difference(SPID) 0-72 | 72 Hours |
Secondary
| Measure | Time frame |
|---|---|
| Mean change from Baseline in pain intensity difference (PID) | 168 Hours |
Countries
United States
Outcome results
None listed