Study of Safety and Efficacy of Diractin® for the Treatment of Osteoarthritis (OA) of the Knee

Exclusion Criteria

• •Skin lesions or dermatological diseases in the treatment area
• •Directly or indirectly involved in the conduct and administration of this study
• •Received any investigational medicinal product within 30 days prior to Screening Visit or participation in any previous clinical study with Diractin®
• •Pregnancy or lactation
• •Residents of psychiatric wards, prisons or other state institutions
• •Malignancy within the past 2 years
• •Depressive disorders requiring treatment with tricyclics, treatment with other antidepressants must be stable for 3 months prior to screening and throughout the study
• •Epilepsy
• •Schizophrenia
• •Neuropathic pain and any other pain condition requiring chronic use of pain medication
• •Known hypersensitivity or allergy (including photoallergy) to NSAID´s including ketoprofen and to ingredients of the IMP
• •Preexisting asthma or bronchospasm after taking aspirin or other NSAIDs
• •Unable to discontinue analgesic therapy including opioids, NSAID´s, tramadol, muscle relaxants, gabapentin, pregabalin, duloxetine, venlafaxine, capsaicine or other drugs approved or used for the treatment of pain for the duration of the study