A Study to Evaluate Safety and Efficacy of Oral Febuxostat in Patients With Gout

Astellas

Status and phase

Completed

Phase 3

Conditions

Gout

Treatments

Drug: febuxostat

Drug: Allopurinol

Study type

Interventional

Funder types

Industry

Identifiers

NCT01736514

TMXALL-1001-TW

Details and patient eligibility

About

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.

Enrollment

109 patients

Sex

All

Ages

20 to 65 years old

Volunteers

No Healthy Volunteers

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