Efficacy and Safety of HSK16149 Capsule in Chinese Patients With Diabetic Peripheral Neuropathic Pain Who Had an Inadequate Response to Pregabalin: A Prospective, Multicenter, Randomized, Double-Blind, Double-Dummy, Pregabalin-controlled Phase 2 Study
Investigate the efficacy and safety of HSK16149 capsule in Chinese patients with Diabetic Peripheral Neuropathic Pain (DPNP) who had an inadequate response to Pregabalin, following 4 weeks treatment in comparison to Pregabalin
• Signed informed consent;
• Males or females aged 18-75 years of age inclusive;
• Diagnosis of diabetic peripheral neuropathic pain (DPNP) and diabetic peripheral neuropathy (DPN) pain ≥ 6 months;
• HbA1c ≤ 11.0% at screening and on a stable anti-diabetic medication regimen for at least 30 days prior to screening;
• Have a visual analog scale (VAS) pain value ≥60 mm in the past 24 h during screening;
• DPNP patients are currently receiving continuous treatment with pregabalin for more than 4 weeks who had an inadequate response.