Health TrialsbyHealthPanel

Clinical Study of HRS-2129 for Acute Gouty Arthritis

ConditionAcute Gouty Arthritis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorShandong Suncadia Medicine Co., Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Able and willing to provide a written informed consent

Subjects requiring Acute gouty arthritis

Target joint VAS pain score ≥ 50 mm (screening)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • HRS-2129 Tablet

    Drug

    HRS-2129 Tablet; high dose

  • HRS-2129 Tablet

    Drug

    HRS-2129 Tablet; low dose

  • Placebo

    Drug

    HRS-2129 Tablet Placebo

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: Treatment group A: HRS-2129 TabletExperimental treatment 1 intervention
Group B: Treatment group B: HRS-2129 TabletExperimental treatment 1 intervention
Group C: Treatment group C: HRS-2129 Tablet PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

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)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shandong Suncadia Medicine Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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