An Efficacy and Safety Study for the Treatment of Mild to Moderate Acute Pain Associated With Ankle Strain or Sprain.

This is an interventional treatment trial for Acute Pain From Ankle Sprain or Strain Read More

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.