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This is a multi-center, randomized, double-blind, placebo-controlled study design evaluating the safety, efficacy, and PK parameter of HL-1186 tablet for diabetic peripheral neuropathic pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HL-1186 Group 1 | Experimental | Each participant will receive HL-1186 for 12 weeks. |
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| HL-1186 Group 2 | Experimental | Each participant will receive HL-1186 for 12 weeks. |
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| HL-1186 Placebo | Placebo Comparator | Each participant will receive a matching placebo for 12 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HL-1186 | Drug | HL-1186 tablet for oral administration. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in average daily pain score (ADPS) from baseline after 12 weeks of administration | Change from baseline in the weekly mean of the daily Numeric Pain Rating Scale (NPRS) score assessing the worst pain intensity in the last 24 hours. Pain intensity was recorded on 11-point NPRS, score range: 0 to 10, where 0= no pain and 10= worst imaginable pain. | From baseline to the end of treatment at 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | From first day of administration to the end of the last follow-up at Week 16 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yanfang Feng | Contact | +86 21 64311017 | feng_yanfang@hllife.com.cn |
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| HL-1186 |
| Drug |
HL-1186 tablet for oral administration. |
|
| HL-1186 placebo | Drug | HL-1186 placebo tablet for oral administration. |
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