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

Phase 3

• Conditions: Diabetic Neuropathy
• Interventions: Drug: Lyrica; Drug: KW21052; Drug: Lyrica (low dose); Drug: Placebo of Lyrica; Drug: Placebo of KW21052

• Registration Number: NCT01863810
• Lead Sponsor: KunWha Pharmaceutical Co., Ltd.

Brief 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.

Detailed Description

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

Study Timeline

• Status Verified: 2013-05
• Study First Submitted: 2013-05-23
• Study First Submitted QC: 2013-05-28
• Last Update Submitted: 2013-05-28
• Study First Posted: 2013-05-29
• Last Update Posted: 2013-05-29
• Study Start: 2013-08
• Primary Completion: 2014-10
• Study Completion: 2014-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 394

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LYRICA	Lyrica	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.
LYRICA	Lyrica (low dose)	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.
KW21052	Lyrica (low dose)	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.
KW21052	Placebo of Lyrica	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.
LYRICA	Placebo of KW21052	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.
KW21052	KW21052	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.

Primary Outcome Measures

Name	Time	Method
Numerical pain rating scale (NRS)	After 8 weeks of intervention

Secondary Outcome Measures

Name	Time	Method
Change on on the numerical pain rating scale (NRS)	From baseline to 8th week of intervention
Response rate	From baseline to 4th and 8th week of intervention
Clinical Global Impression of Change (CGIC)	After 8 weeks of intervention
Improved quality of life (QoL)	After 4 and 8 weeks of intervention
Drug compliance	During 8 weeks of intervention
Adverse events	Every clinic visit

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of