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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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Dotinurad

    Drug

    The drug used in the treatment group (from week 1 to 4)and the control group (from week 3 to 4). This is the main intervention factor of the study.

  • colchicine

    Drug

    The drugs used throughout the treatment and control groups. In this design, it is part of the background treatment or the standard treatment.

  • etoricoxib

    Drug

    The drugs used by the treatment group and the control group in the first week. It is also part of the background treatment.

Treatment groups

142 Participants
are divided into 2 treatment groups
Group A: treatment groupExperimental treatment 3 interventions
Group B: Control groupExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Compare the days to resolution from enrolment to the resolution of an acute gout flare between the two groups

Time frame
From enrollment to the end of treatment at 12 weeks

Secondary outcomes

1

Compare the main joint visual analogue scale (VAS) scores of the two groups on the 1, 3, 7 and 14 days.

The VAS scores range is from 1 to 10. The higher the score, the more severe the pain.

Time frame
From enrollment to the end of treatment at 1，3，7，14days
2

Compare the proportions of gout flares at 28 days between two groups

Time frame
From enrollment to the end of treatment at 28 days
3

Compare the proportions of subjects whose serum uric acid (SUA) levels were ≤ 360 umol/L at 7, 14 and 28 days between two groups

Time frame
From enrollment to the end of treatment at 7, 14 and 28 days
4

Compare the percentage reduction in SUA from the baseline at 7, 14 and 28 days between two groups

Time frame
From enrollment to the end of treatment at 7, 14 and 28 days

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

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

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: