Acute Gouty Arthritis
Conditions
Brief summary
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.
Interventions
DRUGHRS-2129 Tablet
HRS-2129 Tablet; high dose
DRUGPlacebo
HRS-2129 Tablet Placebo
Sponsors
Shandong Suncadia Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Able and willing to provide a written informed consent 2. Subjects requiring Acute gouty arthritis 3. Target joint VAS pain score ≥ 50 mm (screening)
Exclusion criteria
1. Subjects with a history of severe allergies 2. Subjects with nervous system disease 3. Subjects with a history of mental illness 4. Subjects with abnormal liver and renal function 5. Subjects with poorly controlled hypertensive 6. QTc：\>450ms（male），\>470ms（female） 7. History of cardiac dysrhythmias requiring anti-arrhythmia treatment(s) 8. The investigators determined that other conditions were inappropriate for participation in this clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline inVisual Analogous Scale pain score at 24 hours post first dose | from ICF signing date to 24 hours after 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) |
Secondary
| Measure | 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 | 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) |
Countries
China
Contacts
CONTACTLei Tang
Outcome results
None listed