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

National Taiwan University Hospital21 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Gout

Interventions

Stepwise dose titration of febuxostat and low-dose colchicineDRUG

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 colchicineDRUG

Febuxostat 40 mg, orally, once daily, in week 1-12 Concomitant colchicine 0.5 mg, orally, once daily in week 1-12

Eligibility

Sex: ALLMin age: 20 YearsMax age: 100 Years

Medical Language ↔ Plain English

Ages Eligible for Study: more than 20 years Inclusion Criteria: 1. Hyperuricemia (serum urate ≥7.0 mg/dL and gout by 1977 American College of Rheumatology Criteria 2. Acute gout attack during the last 12 months Exclusion Criteria: 1. Acute gout attack in the last 2 weeks 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

Locations (1)

National Taiwan University Hospital

Taipei, Taiwan

Outcomes

Primary Outcomes

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

The percentage of the patients suffered from gout flare during the first 12 weeks.

Time frame: 12 weeks

Secondary Outcomes

The number of gout flares per patient during the first 12 weeks

Time frame: 12 weeks

The number of gout flares per patient during the second 12 weeks

Time frame: 12 weeks

The percentage of patients with serum urate <6.0mg/dL in 12, 24 weeks

The percentage of patients with serum urate \<6.0mg/dL in 12, 24 weeks

Time frame: 12, 24 weeks

Data from ClinicalTrials.gov

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