Evaluation of the Efficacy and Safety of Diclofenac HPBCD 75mg/ml in Treatment of Pain Following Dental Surgery

Inclusion Criteria: * Patients undergoing surgical extraction of a single fully or partially impacted mandibular 3rd molar requiring bone removal. * Patients experiencing moderate to severe post-operative pain within 6 hours from end of surgery. * Pre-operative laboratory tests in the reference ranges or without clinically significant abnormalities as judged by the Investigator. Exclusion Criteria: * Surgery performed under general anaesthesia, or sedation. * Complications occurring during the surgical procedure or in the period before randomisation as judged by the investigator. * Acute local or systemic infection at the time of surgery that could confound the post-surgical evaluation. * Patients with clinical signs of gastritis, gastro-duodenal ulcer, GI bleeding. Other GI disturbances or disease that in the opinion of the investigator could be negatively affected by the administration of NSAIDs. * Clinical signs or history of coagulation disorders that could be negatively affected by NSAIDs administration. * Hepatic or renal impairment. * Patients with significant cardiac impairment, history of cerebrovascular disease, history or peripheral arterial disease, uncontrolled hypertension. * Hypersensitivity to diclofenac or other NSAIDs or to one of the study medication components. * Patients under chronic treatment with topical or systemic analgesics/NSAIDs. * Patients under treatment with any medication that may affect the treatment efficacy evaluation. * Patients under treatment with any medication whose concomitant use may be susceptible to interactions with diclofenac or may affect safety.