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

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

Official Title
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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

Conditions
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Diabetic Neuropathy

Intervention / Treatment
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* Drug: KW21052
* Drug: Lyrica
* Drug: Lyrica (low dose)
* Drug: Placebo of KW21052
* Drug: Placebo of Lyrica


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: KW21052<br>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. | Drug: KW21052<br>* 1 Tablet contains 300mg of pregabalin. Oral, once a day, for 8 weeks.<br>Drug: Lyrica (low dose)<br>* 1 Capsule contains 75mg of pregabalin. Oral, twice a day, for 1 week.<br>Drug: Placebo of Lyrica<br>* Oral, twice a day, for 8 weeks.<br>|
| Active Comparator: LYRICA<br>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. | Drug: Lyrica<br>* 1 Capsule contains 150mg of pregabalin. Oral, twice a day, for 8 weeks.<br>Drug: Lyrica (low dose)<br>* 1 Capsule contains 75mg of pregabalin. Oral, twice a day, for 1 week.<br>Drug: Placebo of KW21052<br>* Oral,once a day, for 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numerical pain rating scale (NRS) |  | After 8 weeks of intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetic Neuropathy, Neuropathic Pain, Pregabalin