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Trial · NCT06653686

Registered outcomes16

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryThe number of gout flares during the treatment periodFrom enrollment to the end of treatment at 20 weeks
SecondaryThe proportion of patients experiencing ≥1 or ≥2 gout flares during the treatment periodFrom enrollment to the end of treatment at 20 weeks
SecondaryThe time to the first gout flare during the treatment periodFrom enrollment to the end of treatment at 20 weeks
SecondaryChanges in serum uric acid levels by the end of the treatment periodFrom enrollment to the end of treatment at 20 weeksSerum uric acid levels will be measured using Uricase-UV method. The change in uric acid levels from baseline to the end of the treatment period will be analyzed.
SecondaryProportion of patients achieving target uric acid levels by the end of the treatment periodFrom enrollment to the end of treatment at 20 weeksThe proportion of patients achieving a target serum uric acid level of \< 360μmol/L will be calculated at the end of the treatment period, using Uricase-UV method to assess uric acid levels.
SecondaryPercentage reduction in febuxostat dosage by the end of the treatment periodFrom enrollment to the end of treatment at 20 weeksPercentage reduction in febuxostat dosage by the end of the treatment period, investigating changes in febuxostat dosage in the trial and control groups during the study.
SecondaryChanges in the volume of monosodium urate (MSU) in target joints by the end of the treatment periodFrom enrollment to the end of treatment at 20 weeks
SecondaryChanges in C-reactive protein (CRP) levels by the end of the treatment periodFrom enrollment to the end of treatment at 20 weeksCRP will be measured using the immunoturbidimetric method, and changes from baseline to the end of the treatment period will be evaluated.
SecondaryChanges in erythrocyte sedimentation rate (ESR) by the end of the treatment periodFrom enrollment to the end of treatment at 20 weeksESR will be measured using an instrument-based method, and changes from baseline to the end of the treatment period will be assessed.
SecondaryChanges in TH1/TH2-related cytokines by the end of the treatment periodFrom enrollment to the end of treatment at 20 weeksThese cytokines will be measured using flow cytometry, and changes from baseline to the end of the treatment period will be evaluated.
SecondaryChanges in fasting blood glucose at the end of the treatment periodFrom enrollment to the end of treatment at 20 weeksFasting blood glucose will be measured using the glucose oxidase method, and the change from baseline to the end of the treatment period will be evaluated.
SecondaryChanges in lipid levels at the end of the treatment periodFrom enrollment to the end of treatment at 20 weeks
Lipid levels (including triglycerides, cholesterol, high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol) will be measured using enzymatic methods or homogeneous enzymatic colorimetric methods. The overall change in lipid levels from baseline to the end of the treatment period will be assessed.
SecondaryChanges in quality of life by the end of the treatment periodFrom enrollment to the end of treatment at 20 weeksChanges in quality of life assessed by the The Short-From-36 Health Survey(SF-36). The SF-36 Physical Functioning Scale ranges from 0 to 100, with higher scores indicating better physical function.
SecondaryChanges in physical function by the end of the treatment periodFrom enrollment to the end of treatment at 20 weeks
Changes in physical function at the end of the treatment period were assessed using the Health Assessment Questionnaire (HAQ) Disability Index.The scale ranges from 0 to 3, with higher scores indicating worse physical function.
SecondaryComparison of patient treatment satisfaction at the end of the treatment period.From enrollment to the end of treatment at 20 weeks
Patient satisfaction at the end of the treatment period was assessed using the Treatment Satisfaction Questionnaire.The scale ranges from 0 to 28, with higher scores indicating greater satisfaction with the treatment.
SecondaryIncidence of adverse eventsFrom enrollment to the end of study at 24 weeks

Source ClinicalTrials.govtrials-2026-11-12-0.4.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNone stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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