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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
90
HRS-2129 Tablet; high dose
HRS-2129 Tablet; low dose
HRS-2129 Tablet Placebo
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGNanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
RECRUITINGChange 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)
Time frame: from ICF signing date to 24 hours after first dose
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
Time frame: 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
Time frame: from ICF signing date to 15 days after first dose
Mean daily VAS pain score change from baseline (on-treatment)
Time frame: from ICF signing date to 15 days after first dose
Safety:Incidence and severity of AE/SAE
Time frame: from ICF signing date to day 14 after last dose(14 days)
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