Hyperuricemia and gout
Conditions
Interventions
None listed
Sponsors
Clinical research consortium on uric acid
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who fulfill all three of the criteria below are eligible for the study: 1) Gout/hyperuricemia patients who have not been treated with any uric acid-lowering drugs during the two weeks prior to obtainment of informed consent and have serum uric acid level of 7.0 mg/dL or higher 2) Patients aged 20 years or older at the time of obtainment of informed consent (regardless of sex and inpatient/outpatient status) 3) Patients who consent in writing to participate in the study
Exclusion criteria
Exclusion criteria: Patients who meet any of the 10 criteria below are ineligible for the study: 1) Patients who have a past history of hypersensitivity to febuxostat 2) Secondary hyperuricemia patients 3) Patients who have twice as high AST or ALT as the hospital's reference value 4) Males with serum creatinine level of 2.0 mg/dL or higher and females with serum creatinine level of 1.5 mg/dL or higher 5) Patients who have or have had past history of malignant tumor as a complication requiring treatment 6) Patients who are being treated with either mercaptopurine hydrate or azathioprine 7) Patients who are undergoing hormone replacement therapy (HRT) 8) Patients who are or are likely to become pregnant, and those who are lactating 9) Patients who participated in another clinical study or clinical trial in the six months prior to the confirmation of eligibility 10) Patients who the doctor in charge judges are ineligible for the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The serum uric acid-lowering rate at Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| - The goal attainment rate for serum uric acid level of 6.0 mg/dL or lower at Week 12 - The uric acid-lowering effects at Weeks 4 and 8 [serum uric acid-lowering rate, goal attainment rate (serum uric acid level of 6.0 mg/dL or lower)] | — |
Countries
Japan
Contacts
Public ContactTakashi Oi
Mebix, Inc. Clinical Research III
Outcome results
None listed