 The primary end-point for efficacy will be the patients assessment of pain on active movement on Day 3, the secondary end-points for efficacy will be: Patients assessment of pain on active movement during the last 24 hours, patients assessment of pain at rest, the Brief Pain Inventory, final global assessment of efficacy by patient at the end of the treatment, final global assessment of efficacy by investigator at the end of the treatment, withdrawal due to inadequate efficacy, patients status change in painful condition at the end of therapy and paracetamol consumption used as rescue medication. The secondary end-points for safety and tolerability will be: Incidence and intensity of adverse events, final global assessment of tolerability by patient, final global assessment of tolerability by investigator, incidence of laboratory-related adverse events, and withdrawal of patients due to adverse events. 