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

Gout Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04697602
• Other study ID #: 202009131MIND
• Status: Terminated
• Phase: N/A
• Start date: January 20, 2021
• Est. completion date: August 23, 2023

Study information

• Verified date: November 2023
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 21
• Est. completion date: August 23, 2023
• Est. primary completion date: August 23, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Gout

Intervention

Drug:
• Stepwise 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
• Fixed 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

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
National Taiwan University Hospital	National Taiwan University Hospital, Yun-Lin Branch

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 weeks
Secondary	The number of gout flares per patient during the first 12 weeks	The number of gout flares per patient during the first 12 weeks	12 weeks
Secondary	The number of gout flares per patient during the second 12 weeks	The number of gout flares per patient during the second 12 weeks	12 weeks
Secondary	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	12, 24 weeks