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

The Impact of Initiating Dotinurad Urate-Lowering Therapy at Different Time Windows on Gout Flare Resolution Time: A Multicenter, Randomized, Parallel-Controlled Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Gout
• Intervention / Treatment: Drug: Dotinurad; Drug: colchicine; Drug: etoricoxib

Detailed Description

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. At the same time, to compare whether there are differences in the uric acid-lowering effects of initiating Dotinurad treatment at different times.And to evaluate the safety and tolerability of the treatment regimen.

• Study Type: Interventional
• Enrollment (Estimated): 142
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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,).
• Provide a signed written informed consent form.

Exclusion Criteria:

• 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.
• Used anti-inflammatory drugs within 14 days before screening.
• Comorbidities with nephrolithiasis or clinical urinary calculi
• History of kidney transplantation or dialysis.
• Estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m².
• AST or ALT > 2 times the upper limit of normal.
• Systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 100 mmHg during the screening period.
• White blood cell count < 3.5 × 10⁹/L, or platelet count < 100 × 10⁹/L, or hemoglobin < 90 g/L.
• Currently in the treatment period of malignant tumors, or within 6 months after the end of the treatment period.
• Congestive heart failure (New York Heart Association [NYHA] cardiac function classification II-IV), confirmed ischemic heart disease, peripheral artery disease and/or cerebrovascular disease (including patients who have recently undergone coronary artery bypass grafting or angioplasty).
• Hypersensitivity to the study drugs or their excipients, or all of urine alkalinizer (potassium citrate/sodium citrate hydrate compound preparations).
• Have active gastrointestinal ulcers/bleeding, or have had a recurrence of ulcers/bleeding in the past.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: treatment group; The treatment group will be administered dotinurad 2 mg/day, colchicine 1 mg/day, and etoricoxib 120 mg/day (for 1-3 days) or 60 mg/day(for 4-7 days) for a duration of 4 weeks.	Drug: Dotinurad; 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.; Drug: colchicine; The drugs used throughout the treatment and control groups. In this design, it is part of the background treatment or the standard treatment.; Drug: etoricoxib; The drugs used by the treatment group and the control group in the first week. It is also part of the background treatment.
Experimental: Control group; The control group will be administered colchicine 1 mg/day, and etoricoxib 120 mg/day (for 1-3 days) or 60 mg/day(for 4-7 days) for 2 weeks. Then the control group will be administered dotinurad 2mg/day, colchicine 1 mg/day for 2 weeks.	Drug: Dotinurad; 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.; Drug: colchicine; The drugs used throughout the treatment and control groups. In this design, it is part of the background treatment or the standard treatment.; Drug: etoricoxib; The drugs used by the treatment group and the control group in the first week. It is also part of the background treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Compare the days to resolution from enrolment to the resolution of an acute gout flare between the two groups	From enrollment to the end of treatment at 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From enrollment to the end of treatment at 1，3，7，14days
Compare the proportions of gout flares at 28 days between two groups		From enrollment to the end of treatment at 28 days
Compare the proportions of subjects whose serum uric acid (SUA) levels were ≤ 360 umol/L at 7, 14 and 28 days between two groups		From enrollment to the end of treatment at 7, 14 and 28 days
Compare the percentage reduction in SUA from the baseline at 7, 14 and 28 days between two groups		From enrollment to the end of treatment at 7, 14 and 28 days
Compare the C-reactive protein (CRP) levels of the two groups at 7 and 14 days		From enrollment to the end of treatment at 7，14days
Compare the erythrocyte sedimentation rate (ESR) levels of the two groups at 7 and 14 days		From enrollment to the end of treatment at 7，14days

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Wenzhou Medical University
• Collaborators: Wenzhou Central Hospital; The Affiliated People's Hospital of Ningbo University; Yuyao People's Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): July 30, 2026
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): July 30, 2027

Study Registration Dates

• First Submitted: September 14, 2025
• First Submitted That Met QC Criteria: June 16, 2026
• First Posted (Actual): June 22, 2026

Study Record Updates

• Last Update Posted (Actual): June 22, 2026
• Last Update Submitted That Met QC Criteria: June 16, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Crystal Arthropathies; Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Metabolic Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Nutritional and Metabolic Diseases; Gout; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Alkaloids; Sulfones; Etoricoxib; Colchicine; dotinurad
• Other Study ID Numbers: KY2026-011-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No