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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| YHD1119 | Experimental | 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. |
|
| Lyrica | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YHD1119 | Drug | YHD1119 150mg, PO YHD1119 300mg, PO YHD1119 600mg, PO |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yong Chul KIM, M.D.,Ph.D. | Seoul National University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yong Chul Kim | Seoul | South Korea |
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| ID | Term |
|---|---|
| D000069583 | Pregabalin |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
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| Lyrica | Drug | Lyrica 75mg, PO Lyrica 150mg, PO Lyrica 300mg, PO |
|
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| 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 |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |