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

• Status: Unknown status
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: KunWha Pharmaceutical Co., Ltd.
• Treatments: Pregabalin

Criteria

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