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

Phase 3

Completed

• Conditions: Gout
• Interventions: Drug: Allopurinol; Drug: febuxostat

• Registration Number: NCT01736514
• Lead Sponsor: Astellas Pharma Taiwan, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Study First Submitted: 2012-11-27
• Study First Submitted QC: 2012-11-27
• Study First Posted: 2012-11-29
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-28
• Last Update Posted: 2014-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 109

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
allopurinol group	Allopurinol	oral
febuxostat group	febuxostat	oral

Primary Outcome Measures

Name	Time	Method
Proportion of subjects whose serum urate level decreases to < 6.0 mg/dL	week 12

Secondary Outcome Measures

Name	Time	Method
Safety assessed by the incidence of adverse events, physical exam. and vital signs, tabo-tests and 12-lead ECG	Baseline and at week 12
Percent reduction in serum urate levels	Baseline and at week 12