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

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Taiwan University Hospital
• Collaborator: National Taiwan University Hospital, Yun-Lin Branch
• Treatments: Colchicine; Febuxostat

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