Clinical Trial of YHD1119 in Patients With Peripheral Neuropathic Pain

Study Overview
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Brief Summary
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A Randomized, Double-blind, Active-Controlled, Multi-center, Phase 3 Trial to Compare the Safety and Efficacy between YHD1119 and Pregabalin in Patients with Peripheral Neuropathic Pain

Official Title
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A Randomized, Double-blind, Active-Controlled, Multi-center, Phase 3 Trial to Compare the Safety and Efficacy Between YHD1119 and Pregabalin in Patients With Peripheral Neuropathic Pain

Conditions
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Peripheral Neuropathic Pain

Intervention / Treatment
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* Drug: YHD1119
* Drug: Lyrica


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed Informed Consent HbA1c ≤ 9.5% diabetes mellitus patients with pain over 6 months in Diabetic Peripheral Neuropathy or postherpetic Neuralgia patients at least 3 months pain after diagnosis of skin rash due to herpes zooster Exclusion Criteria: Have Brittle diabetes mellitus

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 80 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: YHD1119<br>YHD1119 150mg for the first 1 week, then forced titrated to YHD1119 300mg for the 1 week. And then YHD1119 150 600mg for the 2 weeks, then YHD1119 fixed dose was administrated for 8 weeks. | Drug: YHD1119<br>* YHD1119 150mg, PO YHD1119 300mg, PO YHD1119 600mg, PO<br>* Other names: Pregabalin;|
| Active Comparator: Lyrica<br>Lyrica 150mg for the first 1 week, then forced titrated to Lyrica 300mg for the 1 week. And then Lyrica 150 600mg for the 2 weeks, then Lyrica fixed dose was administrated for 8 weeks. | Drug: Lyrica<br>* Lyrica 75mg, PO Lyrica 150mg, PO Lyrica 300mg, PO<br>* Other names: Pregabalin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline to End of Treatment (EOT) in Weekly Mean Pain Score on the Daily Pain Rating Scale (DPRS) |  | Baseline, Day 85 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Mean Pain Score on the Daily Pain Rating Scale (DPRS) |  | Day 1, 8, 15, 22, 29, 57, 85 | 
| Mean Pain Score on the Daily Pain Rating Scale at each visit |  | Day 1, 8, 15, 22, 29, 57, 85 | 
| Patients proportion of reduction over 30% in Mean Pain Score from Baseline |  | Day 1, 8, 15, 22, 29, 57, 85 | 
| Change of duration-modification from baseline in Mean Pain Score on the Daily Pain Rating Scale (DPRS) |  | Day 1, 8, 15, 22, 29, 57, 85 | 
| Patient Global Impression of Change (PGIC) |  | Day 85 | 
| Clinical Global Impression of Change (CGIC) |  | Day 85 | 
| SF-12 (Short form-12) |  | Baseline, Day 85 | 
| C-SSRS (Columbia Suicide Severity Rating Scale) |  | Baseline, Day 8, 29, 85 |