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

Low-dose Colchicine With or Without Stepwise Dose Titration of Febuxostat for Flare Prophylaxis in Patients With Gout and Hyperuricemia During the Initial Phase of Urate-lowering Therapy: an Open-label Randomized Controlled Trial

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04697602

Enrollment

Registered

2021-01-06

Start date

2021-01-20

Completion date

2023-08-23

Last updated

2023-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gout

Keywords

gout,febuxostat,flare prophylaxis,stepwise dose titration,colchicine

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-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.

Interventions

DRUGStepwise 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

DRUGFixed 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 100 Years

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	Time frame	Description
The incidence rate of gout flare during the first 12 weeks.	12 weeks	The percentage of the patients suffered from gout flare during the first 12 weeks.

Secondary

Measure	Time frame	Description
The number of gout flares per patient during the first 12 weeks	12 weeks	The number of gout flares per patient during the first 12 weeks
The number of gout flares per patient during the second 12 weeks	12 weeks	The number of gout flares per patient during the second 12 weeks
The percentage of patients with serum urate <6.0mg/dL in 12, 24 weeks	12, 24 weeks	The percentage of patients with serum urate \<6.0mg/dL in 12, 24 weeks

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026