Low-dose Colchicine With or Without Stepwise Dose Titration of Febuxostat for Flare Prophylaxis in Gout

  • End date
    Dec 28, 2021
  • participants needed
  • sponsor
    National Taiwan University Hospital
Updated on 28 January 2021


The purpose of this study is to compare the incidence rate of gout flare for subjects with gout and hyperuricemia treated by two different starting doses of febuxostat.


A prospective randomized open-label study comparing dose titration group (stepwise dose titration of febuxostat and low-dose colchicine) and standard treatment group (fixed dose febuxostat and low-dose colchicine) in the subjects with gout and hyperuricemia. The incidence rate of gout flare will be compared between two groups during the first 12 week of febuxostat treatment.

Condition Arthritis, Gout, Arthritis and Arthritic Pain, Gout (Hyperuricemia), Arthritis and Arthritic Pain (Pediatric)
Treatment Stepwise dose titration of febuxostat and low-dose colchicine, Fixed dose febuxostat and low-dose colchicine
Clinical Study IdentifierNCT04697602
SponsorNational Taiwan University Hospital
Last Modified on28 January 2021


Yes No Not Sure

Inclusion Criteria

Hyperuricemia (serum urate 7.0 mg/dL and gout by 1977 American College of Rheumatology Criteria
Acute gout attack during the last 12 months

Exclusion Criteria

Acute gout attack in the last 2 weeks
Urate-lowering therapy in the last 4 weeks
Secondary hyperuricemia
Creatinine 2.0 mg/dL
AST or ALT 2x upper limits of normal
Heart failure (NYHA III-IV)
Hypersensitivity to colchicine, NSAID or febuxostat
Use of NSAID, glucocorticoid, cyclosporine, clarithromycin, mercaptopurine, azathioprine, pyrazinamide, ethambutol, chemotherapy, tacrolimus, losartan, and fenofibrate
Inability to comply with the protocol requirements
The judgement of the investigator that the patient was not an appropriate candidate
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