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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 2012

Interventions

  • Drug: febuxostat
    • oral
  • Drug: Allopurinol
    • oral

Arms, Groups and Cohorts

  • Experimental: febuxostat group
    • oral
  • Active Comparator: allopurinol group
    • oral

Clinical Trial Outcome Measures

Primary Measures

  • Proportion of subjects whose serum urate level decreases to < 6.0 mg/dL
    • Time Frame: week 12

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Astellas Pharma Taiwan, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Medical Director, Study Director, Astellas Pharma Taiwan, Inc.

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