Gout with Hyperuricemia
Conditions
Interventions
Duration: 24 weeks Dosage: Start from 10mg/day febuxostat. Increased to 20 mg/day at the week 5 and to 40mg/day at the week 9. Maintain 40mg/day to the week 24 Administration: PO, s.i.d.
Dur
Sponsors
Clinical research consortium on uric acid
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Patients who fulfill all five criteria below are eligible for the study: 1) Gout patients with uric acid level over 7.0 mg/dL who are not under treatment with any uric-acid lowering drugs; 2) Patients who had gout attack in the last twelve months; 3) Patients are aged 20 years or older at the time of acquisition of informed consent; 4) Patients who are not hospitalized (out-patient status); 5) Patient who consents in writing to participate in the study.
Exclusion criteria
Exclusion criteria: Patients who meet any of the sixteen criteria below are ineligible for the study: 1) Patients who have previous history of hypersensitivity to febuxostat; 2) Patients who have previous history of hypersensitivity to colchicine; 3) Patients who have previous history of hypersensitivity to NSAIDs or patients who have not been affected by NSAIDs; 4) Patients who had gout attack in the last two weeks; 5) Patients who have used any uric-acid lowering drugs in the last four weeks; 6) Patients with secondary hyperuricemia; 7) Patients who have twice as high AST or ALT as the hospital's reference value; 8) Patients with serum creatinine level of 2.0 mg/dL or higher; 9) Patients who have or have had past history of malignant tumor as a complication requiring treatment; 10) Patients who are being treated with either mercaptopurine hydrate or azathioprine; 11) Patients with peptic ulcer; 12) Patients with serious hematological disorder; 13) Patients with serious cardiac disorder; 14) Patients with aspirin-induced asthma or its previous history; 15) Patients who participated in another clinical study or clinical trial in the six months prior to the confirmation of eligibility; 16) Patients who the doctor in charge judges are ineligible for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence rate (percentage of the patients who needed analgesic treatment with NSAIDs or adrenal corticosteroid) of gout attack (predictors are not included) during "the treatment period" (the first twelve weeks of the study). | — |
Secondary
| Measure | Time frame |
|---|---|
| - Frequency of occurrence (number of the patients who needed analgesic treatment with NSAIDs or adrenal corticosteroid) of gout attack (predictors are not included) during "the treatment period" (the first twelve weeks of the study); - Frequency of occurrence (Number of the patients who needed analgesic treatment with NSAIDs or adrenal corticosteroid) of gout attack (predictors are not included) during "the observation period" (entire period of the study); - Achievement rate of serum uric-acid level of 6.0 mg/dL or lower during "the observation period" (entire period of the study). | — |
Countries
Japan
Contacts
Public ContactTakashi Oi
Mebix, Inc. Clinical Research III
Outcome results
None listed