The Impact of Initiating Dotinurad Urate-Lowering Therapy at Different Time Windows on Gout Flare Resolution Time
16. juni 2026 oppdatert av: First Affiliated Hospital of Wenzhou Medical University
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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Antatt)
142
Fase
- Fase 4
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
|
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.
The drugs used throughout the treatment and control groups.
In this design, it is part of the background treatment or the standard treatment.
The drugs used by the treatment group and the control group in the first week.
It is also part of the background treatment.
|
|
Eksperimentell: 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.
|
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.
The drugs used throughout the treatment and control groups.
In this design, it is part of the background treatment or the standard treatment.
The drugs used by the treatment group and the control group in the first week.
It is also part of the background treatment.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Compare the days to resolution from enrolment to the resolution of an acute gout flare between the two groups
Tidsramme: From enrollment to the end of treatment at 12 weeks
|
From enrollment to the end of treatment at 12 weeks
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Compare the main joint visual analogue scale (VAS) scores of the two groups on the 1, 3, 7 and 14 days.
Tidsramme: From enrollment to the end of treatment at 1，3，7，14days
|
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
Tidsramme: From enrollment to the end of treatment at 28 days
|
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
Tidsramme: From enrollment to the end of treatment at 7, 14 and 28 days
|
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
Tidsramme: From enrollment to the end of treatment at 7, 14 and 28 days
|
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
Tidsramme: From enrollment to the end of treatment at 7，14days
|
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
Tidsramme: From enrollment to the end of treatment at 7，14days
|
From enrollment to the end of treatment at 7，14days
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
30. juli 2026
Primær fullføring (Antatt)
30. juli 2027
Studiet fullført (Antatt)
30. juli 2027
Datoer for studieregistrering
Først innsendt
14. september 2025
Først innsendt som oppfylte QC-kriteriene
16. juni 2026
Først lagt ut (Faktiske)
22. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
22. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
16. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Krystallarthropatier
- Muskel- og skjelettsykdommer
- Leddgikt
- Leddsykdommer
- Revmatiske sykdommer
- Purin-Pyrimidin-metabolisme, medfødte feil
- Metabolisme, medfødte feil
- Genetiske sykdommer, medfødte
- Metabolske sykdommer
- Medfødte, arvelige og neonatale sykdommer og abnormiteter
- Ernæringsmessige og metabolske sykdommer
- Gikt
- Svovelforbindelser
- Organiske kjemikalier
- Pyridiner
- Heterocykliske forbindelser, 1-ring
- Heterocykliske forbindelser
- Alkaloider
- Sulfoner
- Etorikoksib
- Kolkisin
- Dotinurad
Andre studie-ID-numre
- KY2026-011-01
Legemiddel- og utstyrsinformasjon, studiedokumenter
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Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
produkt produsert i og eksportert fra USA
Nei
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