The Impact of Initiating Dotinurad Urate-Lowering Therapy at Different Time Windows on Gout Flare Resolution Time

ConditionGout
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-70
SponsorFirst Affiliated Hospital of Wenzhou Medical University

About this trial

To confirm that initiating Dotinurad for uric acid uric acid lowering during the acute phase of gout is non-inferior to initiating it after the acute phase of gout has subsided, and to analyze whether initiating Dotinurad treatment during the acute phase will increase the pain level, the recurrence rate of gout, and the inflammatory level of patients.

Eligibility criteria

Qualifiers

Male or female individuals aged 18-70 years old.

Meet the 2015 ACR/EULAR diagnostic criteria of gout.

With an onset of acute gout flares within 7 days.

With gout experiencing gout flares ≥2 times; or with gout experiencing gout flares 1 time and is younger than 40 years old; or with gout experiencing gout flares 1 time and has a serum uric acid level greater than 480 μmol/L and/or has co-morbidities (renal function impairment, hypertension,).

Disqualifiers

Has secondary hyperuricemia.

Serum uric acid level < 360 μmol/L.

Used IL-1β inhibitors within 6 months before screening.

Used uric acid-lowering drugs within 1 month before screening.

Trial design

Treatments tested in this trial

  • Dotinurad
  • colchicine
  • etoricoxib

Treatment groups

142 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

First Affiliated Hospital of Wenzhou Medical University

Lead sponsor

The Affiliated People's Hospital of Ningbo University

Collaborator

Wenzhou Central Hospital

Collaborator

Yuyao People's Hospital

Collaborator