Gout
Conditions
Keywords
xanthine oxidase inhibitor, Uric acid lowering drug
Brief summary
This is a multicenter, open label, randomized, allopurinol-controlled, parallel-design study. Approximately 120 subjects will be randomly assigned in 1:1 ratio to receive febuxostat, or allopurinol for subjects with gout.
Interventions
DRUGfebuxostat
oral
DRUGAllopurinol
oral
Sponsors
Astellas Pharma Taiwan, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Subjects will also have a history or presence of gout as defined by the American College of Rheumatology (ACR) criteria * Subject has serum urate level \>= 8.0 mg/dL at the screening Visit
Exclusion criteria
* Female subject who is breast-feeding or pregnant * Subject has a history of xanthinuria * Subject who is intolerant of allopurinol, ie hypersensitivity, Steven-Johnson syndrome/topic epidermal necrolysis * Subject who takes allopurinol \> 300 mg/day and with serum urate level \> 8mg/dL * Subject who is HLA B\*5801 positive * Subject who is receiving thiazide diuretic therapy * Subject who has secondary hyperuricemia * Subject who requires concurrent therapy with any systemic or topical medications, prescribed or non-prescribed, containing aspirin or other salicylates (low doses of aspirin will be allowed(ie. =\< 325mg/day) * Subject who requires therapy with prednisone \> 10 mg/ day during the study * Subject who has active liver disease or hepatic dysfunction, defined as both ALT and AST \> 1.5 times the upper limit of normal * Subject who has serum creatinine \>= 1.5mg/dL * Subject who has any another significant medical condition as defined by the investigator that would interfere with the treatment, safety or compliance with the protocol (eg. A clinically significant ECG result) * Subject who has a history of cancer (other than basal cell carcinoma of the skin) within 5 years prior to the study, or has taken any systemic cancer chemotherapy within 5 years prior to the study * Subject who has previously participated in a clinical study in which febuxostat was administered * Subject who has participated in another investigational trial within the 30 days prior to the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects whose serum urate level decreases to < 6.0 mg/dL | week 12 |
Secondary
| Measure | Time frame |
|---|---|
| Percent reduction in serum urate levels | Baseline and at week 12 |
| Safety assessed by the incidence of adverse events, physical exam. and vital signs, tabo-tests and 12-lead ECG | Baseline and at week 12 |
Countries
Taiwan
Outcome results
None listed