Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07706777

Clinical Study of HRS-2129 for Acute Gouty Arthritis

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Acute Gouty Arthritis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HRS-2129 Tablet

Drug

HRS-2129 Tablet; high dose

Placebo

Drug

HRS-2129 Tablet Placebo

Primary outcomes

  1. 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

    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 outcomes

  1. 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

  2. Time until complete disappearance of pain in the target joint

    Time frame: from ICF signing date to 15 days after first dose

  3. Mean daily VAS pain score change from baseline (on-treatment)

    Time frame: from ICF signing date to 15 days after first dose

  4. Safety：Incidence and severity of AE/SAE

    Time frame: from ICF signing date to day 14 after last dose(14 days)

Study contacts

Contact information is provided by the study sponsor or research team.

Lei Tang

CONTACT

[email protected]

+0518-82342973

Sponsors and collaborators

Lead sponsor

Shandong Suncadia Medicine Co., Ltd.

Industry

Registry information

Official study title

Clinical Study on Safety and Efficacy of HRS-2129 for Acute Gouty Arthritis

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 16, 2026
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.