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

NCT07661030 | Not Yet Recruiting Phase 4

• 1 other identifier: KY2026-011-01
• Study Type: interventional
• Target: 142
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Gout

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

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

  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

Study Arms (2)

treatment group

EXPERIMENTAL

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; Drug: colchicine; Drug: etoricoxib

Control group

EXPERIMENTAL

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; Drug: colchicine; Drug: etoricoxib

Interventions

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.

Control group; treatment group

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.

Control group; treatment group

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.

Control group; treatment group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital of Wenzhou Medical University: lead
• The Affiliated People's Hospital of Ningbo University: collaborator
• Wenzhou Central Hospital: collaborator
• Yuyao People's Hospital: collaborator

MeSH Terms

Conditions

Gout

Interventions

dotinurad; Colchicine; Etoricoxib

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds; Sulfones; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2025
• First Posted: June 22, 2026
• Study Start: July 30, 2026
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): July 30, 2027
• Last Updated: June 22, 2026

Record last verified: 2026-06