Not yet recruiting NCT07706777
Clinical Study of HRS-2129 for Acute Gouty Arthritis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HRS-2129 Tablet, HRS-2129 Tablet, Placebo.
- Who it may be relevant to
- Registry conditions: Acute Gouty Arthritis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Clinical Study on Safety and Efficacy of HRS-2129 for Acute Gouty Arthritis
Overview
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
- Drug HRS-2129 Tablet
HRS-2129 Tablet; high dose - Drug HRS-2129 Tablet
HRS-2129 Tablet; low dose - Drug Placebo
HRS-2129 Tablet Placebo
Primary outcome measures
- Change from baseline inVisual Analogous Scale pain score at 24 hours post first dose [Time frame: from ICF signing date to 24 hours after first dose]
Secondary outcome measures (4)
- 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)]
Eligibility criteria
Inclusion criteria
- Able and willing to provide a written informed consent
- Subjects requiring Acute gouty arthritis
- Target joint VAS pain score ≥ 50 mm (screening)
Exclusion criteria
- Subjects with a history of severe allergies
- Subjects with nervous system disease
- Subjects with a history of mental illness
- Subjects with abnormal liver and renal function
- Subjects with poorly controlled hypertensive
- QTc：>450ms（male），>470ms（female）
- History of cardiac dysrhythmias requiring anti-arrhythmia treatment(s)
- The investigators determined that other conditions were inappropriate for participation in this clinical trial
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 2 centers
- The Third Affiliated Hospital of Sun Yat-sen University — Guangzhou
- Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School — Nanjing
Identifiers
NCT: NCT07706777 · HRS-2129-207