Low-dose Colchicine With or Without Stepwise Dose Titration of Febuxostat for Flare Prophylaxis in Gout
NCT ID: NCT04697602
Last Updated: 2023-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
21 participants
INTERVENTIONAL
2021-01-20
2023-08-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Dose titration group
Stepwise dose titration of febuxostat and low-dose colchicine
Stepwise dose titration of febuxostat and low-dose colchicine
Febuxostat 10 mg, orally, once daily, in week 1-4 Febuxostat 20 mg, orally, once daily, in week 5-8 Febuxostat 40 mg, orally, once daily, in week 9-12 Concomitant colchicine 0.5 mg, orally, once daily in week 1-12
Standard treatment group
Fixed dose febuxostat and low-dose colchicine
Fixed dose febuxostat and low-dose colchicine
Febuxostat 40 mg, orally, once daily, in week 1-12 Concomitant colchicine 0.5 mg, orally, once daily in week 1-12
Interventions
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Stepwise dose titration of febuxostat and low-dose colchicine
Febuxostat 10 mg, orally, once daily, in week 1-4 Febuxostat 20 mg, orally, once daily, in week 5-8 Febuxostat 40 mg, orally, once daily, in week 9-12 Concomitant colchicine 0.5 mg, orally, once daily in week 1-12
Fixed dose febuxostat and low-dose colchicine
Febuxostat 40 mg, orally, once daily, in week 1-12 Concomitant colchicine 0.5 mg, orally, once daily in week 1-12
Eligibility Criteria
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Inclusion Criteria
2. Acute gout attack during the last 12 months
Exclusion Criteria
2. Urate-lowering therapy in the last 4 weeks
3. Secondary hyperuricemia
4. Creatinine ≥2.0 mg/dL
5. AST or ALT ≥2x upper limits of normal
6. Heart failure (NYHA III-IV)
7. Hypersensitivity to colchicine, NSAID or febuxostat
8. Use of NSAID, glucocorticoid, cyclosporine, clarithromycin, mercaptopurine, azathioprine, pyrazinamide, ethambutol, chemotherapy, tacrolimus, losartan, and fenofibrate
9. Inability to comply with the protocol requirements
10. The judgement of the investigator that the patient was not an appropriate candidate
20 Years
100 Years
ALL
No
Sponsors
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National Taiwan University Hospital, Yun-Lin Branch
OTHER
National Taiwan University Hospital
OTHER
Responsible Party
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Principal Investigators
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Yi-Min Huang
Role: PRINCIPAL_INVESTIGATOR
National Taiwan University Hospital, Yun-Lin Branch
Locations
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National Taiwan University Hospital
Taipei, , Taiwan
Countries
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Other Identifiers
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202009131MIND
Identifier Type: -
Identifier Source: org_study_id
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