TerminatedNot Applicable

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

Stopped: Slow recruitment

Taiwan21 participantsStarted 2021-01-20

Plain-language summary

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.

Who can participate

Age range20 Years – 100 Years

SexALL

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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

What they're measuring

The incidence rate of gout flare during the first 12 weeks.

Timeframe: 12 weeks

Trial details

NCT IDNCT04697602

SponsorNational Taiwan University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-08-23

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