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

Sponsor

Astellas Pharma Taiwan, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT01736514

Collaborator

(none)

109

Enrollment

Locations

Arms

11.1

Duration (Months)

27.3

Patients Per Site

2.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gout	Drug: febuxostat Drug: Allopurinol	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

109 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Randomized, Open Label, Multicenter, Allopurinol- Controlled Study to Assess the Safety and Efficacy of Oral Febuxostat in Patients With Gout

Study Start Date :

Mar 1, 2011

Actual Primary Completion Date :

Feb 1, 2012

Actual Study Completion Date :

Feb 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: febuxostat group oral	Drug: febuxostat oral Other Names: Adenuric, Uloric, Feburic
Active Comparator: allopurinol group oral	Drug: Allopurinol oral

Arm

Intervention/Treatment

Experimental: febuxostat group

oral

Drug: febuxostat

oral

Other Names:

Adenuric, Uloric, Feburic

Active Comparator: allopurinol group

oral

Drug: Allopurinol

oral

Outcome Measures

Primary Outcome Measures

Proportion of subjects whose serum urate level decreases to < 6.0 mg/dL [week 12]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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