Phase III Trial to Evaluate the Efficacy and Safety in Patients With Ankle Sprains.

Inclusion Criteria: * acute ankle sprains Grade I * location of injury such that pain-on-movement (POM) is elicited on active standardized movement * enrollment within 6 hours of the injury * baseline VAS score for POM of injured extremity \> 50 mm on a 100 mm VAS * adult male or female patients * age 18 to 64 years (including) * having given written informed consent * satisfactory health as determined by the Investigator based on medical history and physical examination. Exclusion Criteria: * significant concomitant injury in association with the index soft- tissue injury/contusion or strain; e.g. fracture, nerve injury, ligament disruption, tear of muscle or cartilage, or open wound * current skin disorder or shaving hair at application site * history of excessive sweating/hyperhidrosis inclusive of application site * intake of non-steroidal anti-inflammatory drags (NSAIDs) or analgesics within 36 hours, opioids within 7 days, or corticosteroids (except inhaled corticosteroids for e.g. topical treatment of bronchial asthma) within 60 days of inclusion in the study * intake of long-acting NSAIDs or application of topical medication since the injury (Rest, Ice, Compression, and elevation (RICE) allowed) * participation in a clinical study within 30 days before inclusion in the study or concomitantly * participation in this clinical study in another center * drug or alcohol abuse in the opinion of the Investigator * pregnant and lactating women * women of child-bearing pote…