 The secondary objectives of the study will be to evaluate the analgesic activity of the study drug. Analgesic activity will be evaluated with scoring spontaneous pain. In particular, the secondary outcome of the trial will be the change of the Visual Analogue Scale VAS Scale score 100 mm evaluated at baseline and at DAY 5 Visit V5. Moreover, the evaluation of secondary parameters for the analgesic activity and changes on quality of life will be assessed. 