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

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 potential (defined as all women physiologically capable of becoming pregnant) who are not using an acceptable method of contraception defined as:
• •* Surgical sterilization
• •* Combined (estrogen and progestogen containing) hormonal contraception, e.g., oral, intravaginal, transdermal and progestogen-only hormonal contraception e.g. oral, injectable, implantable as well as intrauterine device (IUD) and intrauterine hormone-releasing system (IUS) each in combination with male condom to increase safety effect (double barrier method)
• •* Total abstinence throughout the study at the discretion of the Investigator
• •* Periodic abstinence is NOT an acceptable method of contraception. An acceptable method of contraception must be maintained throughout the study
• •* A woman who is post-menopausal must have a negative urine pregnancy test at screening but will not need to comply with an acceptable method of contraception. Women are considered post-menopausal and not of child bearing potential if they had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of sterilisation, salpingectomy) or 6 months of spontaneous amenorrhea with serum Follic simulating hormone (FSH) levels \> 40 mIU/mL or have had surgical bilateral oophorectomy (with or without hysterectomy) at least 6 weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment
• •known hypersensitivity to Esflurbiprofen, R-flurbiprofen or one of the excipients of the patch
• •patients with any ongoing condition that may interfere with the absorption, distribution, metabolism, or excretion of Esflurbiprofen
• •history of previous significant injury to the same extremity within 6 months
• •patients with a disease affecting the same limb, such as synovitis, rheumatoid arthritis, arthrosis, etc.
• •patients having an ongoing painful condition associated with blunt injury/contusion
• •patients suffering from symptoms of an infectious disease including swelling of any joint of the affected lower limbs
• •patients who had surgery of the affected lower limb within one year of study entry
• •patients with significant diseases (defined as a disease which, in the opinion of the Investigator, may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient's ability to participate in the study; includes patients with a history of gastrointestinal bleeding, significant cardiovascular, liver or renal disease)
• •patients with a blood coagulation disorder
• •patients who use any impermissible medication
• •known allergy to paracetamol and galenic components of the rescue medication