Efficacy and Safety of the N0750 Compared to Monotherapies in the Treatment of Painful Diabetic Peripheral Neuropathy

The objective of this clinical trial is to demonstrate the superiority of treatment with N0750 compared to monotherapy with Cymbalta® (duloxetine hydrochloride 60 mg, delayed-release capsule) and Lyrica® (pregabalin 150 mg, hard capsule, given twice daily for a total daily dose of 300 mg). The clinical trial population will consist of patients of both sexes, diagnosed with PDPN for at least 3 months, confirmed by the presence of signs and symptoms in the Neuropathic Impairment Score (NIS) and Neuropathic Symptom Score (NSS), respectively, and with pain ≥ 6 points on the Numerical Scale (11 points \[0-10\]). The primary objective of this clinical trial is to evaluate the reduction in pain intensity associated with Diabetic Peripheral Neuropathy (DPN). The primary endpoint of the trial is the change from baseline (Randomisation Visit \[RV\]) at the end of 12 weeks of treatment (Visit 4) in the weekly mean pain intensity in the last 24 hours, as assessed by the Numerical Rating Scale (11 points \[0-10\]).