A Phase 2 interventional study of HRS-2129 Tablet and HRS-2129 Tablet in Acute Gouty Arthritis, sponsored by Shandong Suncadia Medicine Co., Ltd.. Recruiting at 2 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-03.
Sponsored by Shandong Suncadia Medicine Co., Ltd. (part of Jiangsu HengRui Medicine Co., Ltd.) · Phase 2, Interventional, and Treatment
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.
47 studies on the registry are indexed under Arthritis, Gouty; 16 are open to participants now.
This study's planned enrollment of 90 is below the median of 140 across 35 interventional studies indexed under Arthritis, Gouty.
Browse Arthritis, Gouty studies →Shandong Suncadia Medicine Co., Ltd. is the lead sponsor of 87 studies on the registry; 40 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: HRS-2129 Tablet
Drug: HRS-2129 Tablet
Drug: Placebo
HRS-2129 Tablet; high dose
HRS-2129 Tablet; low dose
HRS-2129 Tablet Placebo
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)
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)
Plan to share: Undecided
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Studies of the drug tested here: HRS-2129
Shandong Suncadia Medicine Co., Ltd. →