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

KunWha Pharmaceutical

Status and phase: Unknown; Phase 3

Conditions: Diabetic Neuropathy

Treatments: Drug: Lyrica (low dose); Drug: Lyrica; Drug: KW21052; Drug: Placebo of KW21052; Drug: Placebo of Lyrica

Study type: Interventional

Funder types: Industry

Identifiers

NCT01863810

KW21052_P3

Details and patient eligibility

About

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.

Full description

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

Enrollment: 394 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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394 participants in 2 patient groups

KW21052

Experimental group

Description:

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.

Treatment:

Drug: Lyrica (low dose)

Drug: Placebo of Lyrica

Drug: KW21052

LYRICA

Active Comparator group

Description:

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.

Treatment:

Drug: Lyrica (low dose)

Drug: Placebo of KW21052

Drug: Lyrica