Status:
TERMINATED
Low-dose Colchicine With or Without Stepwise Dose Titration of Febuxostat for Flare Prophylaxis in Gout
Lead Sponsor:
National Taiwan University Hospital
Collaborating Sponsors:
National Taiwan University Hospital, Yun-Lin Branch
Conditions:
Gout
Eligibility:
All Genders
20-100 years
Phase:
NA
Brief 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.
Detailed Description
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-dos...
Eligibility Criteria
Inclusion
- Ages Eligible for Study: more than 20 years
- 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
- 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
Key Trial Info
Start Date :
January 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 23 2023
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT04697602
Start Date
January 20 2021
End Date
August 23 2023
Last Update
November 14 2023
Active Locations (1)
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1
National Taiwan University Hospital
Taipei, Taiwan