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

Not Applicable

Terminated

• Conditions: Gout
• Interventions: Drug: Stepwise dose titration of febuxostat and low-dose colchicine; Drug: Fixed dose febuxostat and low-dose colchicine

• Registration Number: NCT04697602
• Lead Sponsor: National Taiwan University Hospital

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.

Study Timeline

• Study First Submitted: 2021-01-05
• Study First Submitted QC: 2021-01-05
• Study First Posted: 2021-01-06
• Study Start: 2021-01-20
• Primary Completion: 2023-08-23
• Study Completion: 2023-08-23
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-09
• Last Update Posted: 2023-11-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 21

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dose titration group	Stepwise dose titration of febuxostat and low-dose colchicine	Stepwise dose titration of febuxostat and low-dose colchicine
Standard treatment group	Fixed dose febuxostat and low-dose colchicine	Fixed dose febuxostat and low-dose colchicine

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan