Efficacy and Safety of Esflurbiprofen Hydrogel Patch in the Treatment of Local Acute Pain

Inclusion criteria 1. acute sports-related soft-tissue injury/contusion (strains, sprains, bruises) of the upper or lower limb 2. location of injury such that pain-on-movement (POM) is elicited on by specified exercises 3. enrollment within 6 hours of the injury 4. baseline VAS score for POM of injured extremity \> 50 mm on a 100 mm VAS 5. size of injury, as assessed by investigator, ≥ 25 cm2 and ≤ 120 cm2 6. adult male or female patients 7. age 18 to 60 years 8. having given written informed consent 9. satisfactory health as determined by the Investigator based on medical history and physical examination. Exclusion criteria 1. significant concomitant injury in association with the index acute sports-related soft- tissue injury/contusion; e.g. fracture, nerve injury, ligament disruption, tear of muscle or cartilage, or open wound 2. excessively hairy skin at application site, cutting the hair in the injured site prior to patch application will qualify for inclusion 3. current skin disorder or shaving hair at application site 4. history of excessive sweating/hyperhidrosis inclusive of application site 5. intake of NSAIDs or analgesics within 36 hours, opioids within 7 days, or corticosteroids within 60 days of inclusion in the study 6. intake of long-acting NSAIDs or application of topical medication since the injury (RICE allowed) 7. participation in a clinical study within 30 days before inclusion in the study or concomitantly 8. drug or alcohol abuse in the opinion of the investigator 9. Pregnant and lactating women 10. Women of child-bearing potential (defined as all women physiologically capable of becoming pregnant) who are not using an acceptable method of contraception defined as: * Surgical sterilization * Hormonal contraception * Intra Uterine Device * Double barrier method * Total abstinence throughout the study at the discretion of the Investigator.