Efficacy and Safety of KW21052 Compared to Lyrica in the Diabetic Patients With Neuropathic Pain

Randomized, Double-blinded, Double-dummy, Active-controlled, Multi-center Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of KW21052 for 8 Weeks Compared to Pregabalin (Lyrica) in the Diabetic Patients With Neuropathic Pain

Diabetic neuropathy is known to be the most common complication of diabetes, although the estimated prevalence is highly variable, ranging from 1.6 to 90%. Also, chronic pain is accompanied with sleep disorders, depression, and anxiety, thereby impairing quality of life and increasing societal costs. Pregabalin is one of proven and marketed oral medicine to manage the chronic neuropathic pain in diabetic patients. This study is designed as a randomized controlled trial to demonstrate that the efficacy of KW21052 in pain reduction measured by the weekly mean pain score on the numerical pain rating scale (NRS) at the 8th week of intervention is inferior to that of Lyrica.

Patient Reported Outcomes (PRO) using validated questionnaires and patient diaries will be assessed for efficacy analysis.

This arm will be pre-treated with Lyrica 150mg (75mg bid) for titration period of 1 week and then be treated with KW21052 300mg and Placebo of Lyrica for intervention period of 8 weeks.

This arm will be pre-treated with Lyrica 150mg (75mg bid) for titration period of 1 week and then be treated with Lyrica 300mg (150mg bid) and Placebo of KW21052 300mg for intervention period of 8 weeks.

Inclusion Criteria: Type 1 and 2 diabetic patients Patients diagnosed with diabetic, distal, symmetrical, and sensorimotor polyneuropathy 40mm and more on VAS 4 and more on NRS Informed consented patients Exclusion Criteria: Participating in another clinical trial Pregnancy or lactating Sensitivity to pregabalin Significant underlying disease or disorders Prohibited concomitant medications Significant laboratory abnormalities