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

NCT ID: NCT01736514

Last Updated: 2014-10-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 109 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2012-02-29

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.

Conditions

Gout

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

febuxostat group

oral

Group Type: EXPERIMENTAL

febuxostat

Intervention Type: DRUG

oral

allopurinol group

oral

Group Type: ACTIVE_COMPARATOR

Allopurinol

Intervention Type: DRUG

oral

Interventions

febuxostat

oral

Intervention Type: DRUG

Allopurinol

oral

Intervention Type: DRUG

Other Intervention Names

Adenuric, Uloric, Feburic

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Astellas Pharma Taiwan, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Astellas Pharma Taiwan, Inc.

Locations

Kaohsiung City, , Taiwan

Linkou District, , Taiwan

Taichung, , Taiwan

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

TMXALL-1001-TW

Identifier Type: -

Identifier Source: org_study_id