Interim futility analysis

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.

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.