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The study is being conducted to evaluate the safety, and efficacy of HRS-2129 for acute gouty arthritis. To explore the reasonable dosage of HRS-2129 for acute gouty arthritis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A: HRS-2129 Tablet | Experimental |
| |
| Treatment group B: HRS-2129 Tablet | Experimental |
| |
| Treatment group C: HRS-2129 Tablet Placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-2129 Tablet | Drug | HRS-2129 Tablet; high dose |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline inVisual Analogous Scale pain score at 24 hours post first dose | VAS,Visual Analogue Score is an often-used tool to measure subjective phenomena, which has shown good reliability and validity in terms of assessment of pain. In the clinical study of acute gout attack,it can be used as a tool to measure the degree of pain from 0 to 100 mm (with 0 being no pain and 100 being maximum pain) | from ICF signing date to 24 hours after first dose |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in VAS pain score at 1 hour, 2 hours, 6 hours, 12 hours, 18 hours, 24 hours, 48 hours, 72 hours post first dose | from ICF signing date to 1 hour, 2 hours, 6 hours, 12 hours, 18 hours, 24 hours, 48 hours, 72 hours after first dose | |
| Time until complete disappearance of pain in the target joint |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lei Tang | Contact | +0518-82342973 | lei.tang.lt31@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Third Affiliated Hospital of Sun Yat-sen University | Guangzhou | Guangdong | 510630 | China |
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| HRS-2129 Tablet |
| Drug |
HRS-2129 Tablet; low dose |
|
| Placebo | Drug | HRS-2129 Tablet Placebo |
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| from ICF signing date to 15 days after first dose |
| Mean daily VAS pain score change from baseline (on-treatment) | from ICF signing date to 15 days after first dose |
| Safety:Incidence and severity of AE/SAE | from ICF signing date to day 14 after last dose(14 days) |
| Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School | Nanjing | Jiangsu | 210008 | China |
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