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Slow recruitment
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| Name | Class |
|---|---|
| National Taiwan University Hospital, Yun-Lin Branch | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose titration group | Experimental | Stepwise dose titration of febuxostat and low-dose colchicine |
|
| Standard treatment group | Active Comparator | Fixed dose febuxostat and low-dose colchicine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stepwise dose titration of febuxostat and low-dose colchicine | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| The number of gout flares per patient during the second 12 weeks |
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Ages Eligible for Study: more than 20 years
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yi-Min Huang | National Taiwan University Hospital, Yun-Lin Branch | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital | Taipei | Taiwan |
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| ID | Term |
|---|---|
| D006073 | Gout |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D000070657 | Crystal Arthropathies |
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| ID | Term |
|---|---|
| D003078 | Colchicine |
| D000069465 | Febuxostat |
| ID | Term |
|---|---|
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
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|
| Fixed dose febuxostat and low-dose colchicine | Drug | Febuxostat 40 mg, orally, once daily, in week 1-12 Concomitant colchicine 0.5 mg, orally, once daily in week 1-12 |
|
The number of gout flares per patient during the second 12 weeks
| 12 weeks |
| 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 |
| D012216 |
| Rheumatic Diseases |
| D011686 | Purine-Pyrimidine Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D009930 |
| Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |