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

Diabetic Neuropathy Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial Description

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01863810
Study type Interventional
Source KunWha Pharmaceutical Co., Ltd.
Contact Hae-kwan Eo
Phone 82 2 2047 7789
Email hkeo@kunwha.com
Status Not yet recruiting
Phase Phase 3
Start date August 2013
Completion date October 2014
View Details
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