Clinical trial NCT01736514: A Study to Evaluate Safety and Efficacy of Oral Febuxostat in Patients With Gout
Official title: A Randomized, Open Label, Multicenter, Allopurinol- Controlled Study to Assess the Safety and Efficacy of Oral Febuxostat in Patients With Gout
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gout
Keywords: xanthine oxidase inhibitor
Uric acid lowering drug
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2012-11-29
Enrollment: 109
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of subjects whose serum urate level decreases to < 6.0 mg/dL
timeFrame: week 12
Secondary outcomes:
measure: Percent reduction in serum urate levels
timeFrame: Baseline and at week 12
measure: Safety assessed by the incidence of adverse events, physical exam. and vital signs, tabo-tests and 12-lead ECG
timeFrame: Baseline and at week 12
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
city: Linkou
country: Taiwan
city: Taichung
country: Taiwan
city: Taipei
country: Taiwan
Study officials:
affiliation: Astellas Pharma Taiwan, Inc.
name: Medical Director
role: STUDY_DIRECTOR
References: