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

National Taiwan University

Status: Terminated

Conditions: Gout

Treatments: Drug: Stepwise dose titration of febuxostat and low-dose colchicine; Drug: Fixed dose febuxostat and low-dose colchicine

Study type: Interventional

Funder types: Other

Identifiers

NCT04697602

202009131MIND

Details and patient eligibility

About

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.

Full 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-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.

Enrollment: 21 patients

Sex: All

Ages: 20 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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21 participants in 2 patient groups

Dose titration group

Experimental group

Description:

Stepwise dose titration of febuxostat and low-dose colchicine

Treatment:

Drug: Stepwise dose titration of febuxostat and low-dose colchicine

Standard treatment group

Active Comparator group

Description:

Fixed dose febuxostat and low-dose colchicine

Treatment:

Drug: Fixed dose febuxostat and low-dose colchicine