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

This study has been completed.
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Taiwan, Inc. )
ClinicalTrials.gov Identifier:
First received: November 27, 2012
Last updated: October 28, 2014
Last verified: October 2014
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 Intervention Phase
Drug: febuxostat
Drug: Allopurinol
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Proportion of subjects whose serum urate level decreases to < 6.0 mg/dL [ Time Frame: week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percent reduction in serum urate levels [ Time Frame: Baseline and at week 12 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 109
Study Start Date: March 2011
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: febuxostat group
Drug: febuxostat
Other Name: Adenuric, Uloric, Feburic
Active Comparator: allopurinol group
Drug: Allopurinol


Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01736514

Kaohsiung, Taiwan
Linkou, Taiwan
Taichung, Taiwan
Taipei, Taiwan
Sponsors and Collaborators
Astellas Pharma Taiwan, Inc.
Study Director: Medical Director Astellas Pharma Taiwan, Inc.
  More Information

Additional Information:
Responsible Party: Astellas Pharma Inc ( Astellas Pharma Taiwan, Inc. )
ClinicalTrials.gov Identifier: NCT01736514     History of Changes
Other Study ID Numbers: TMXALL-1001-TW 
Study First Received: November 27, 2012
Last Updated: October 28, 2014
Health Authority: Taiwan: Department of Health

Keywords provided by Astellas Pharma Inc:
xanthine oxidase inhibitor
Uric acid lowering drug

Additional relevant MeSH terms:
Genetic Diseases, Inborn
Joint Diseases
Metabolic Diseases
Metabolism, Inborn Errors
Musculoskeletal Diseases
Purine-Pyrimidine Metabolism, Inborn Errors
Rheumatic Diseases
Antirheumatic Agents
Enzyme Inhibitors
Free Radical Scavengers
Gout Suppressants
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Protective Agents

ClinicalTrials.gov processed this record on May 26, 2016