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 activestandardized 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 andphysical examination.

Exclusion Criteria:

• significant concomitant injury in association with the index soft- tissueinjury/contusion or strain; e.g. fracture, nerve injury, ligament disruption, tearof 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 36hours, opioids within 7 days, or corticosteroids (except inhaled corticosteroids fore.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 orconcomitantly

• 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 ofbecoming pregnant) who are not using an acceptable method of contraception definedas:

• Surgical sterilization

• Combined (estrogen and progestogen containing) hormonal contraception, e.g.,oral, intravaginal, transdermal and progestogen-only hormonal contraceptione.g. oral, injectable, implantable as well as intrauterine device (IUD) andintrauterine hormone-releasing system (IUS) each in combination with malecondom 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 acceptablemethod of contraception must be maintained throughout the study

• A woman who is post-menopausal must have a negative urine pregnancy test atscreening but will not need to comply with an acceptable method ofcontraception. Women are considered post-menopausal and not of child bearingpotential if they had 12 months of natural (spontaneous) amenorrhea with anappropriate clinical profile (e.g. age appropriate, history of sterilisation,salpingectomy) or 6 months of spontaneous amenorrhea with serum Follicsimulating hormone (FSH) levels > 40 mIU/mL or have had surgical bilateraloophorectomy (with or without hysterectomy) at least 6 weeks ago. In the caseof oophorectomy alone, only when the reproductive status of the woman has beenconfirmed by follow up hormone level assessment

• known hypersensitivity to Esflurbiprofen, R-flurbiprofen or one of the excipients ofthe 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, rheumatoidarthritis, arthrosis, etc.

• patients having an ongoing painful condition associated with blunt injury/contusion

• patients suffering from symptoms of an infectious disease including swelling of anyjoint 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 ofthe Investigator, may either put the patient at risk because of participation in thestudy or a disease which may influence the results of the study or the patient'sability to participate in the study; includes patients with a history ofgastrointestinal 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