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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01736514
Recruitment Status : Completed
First Posted : November 29, 2012
Last Update Posted : October 29, 2014
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Taiwan, Inc. )

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 Type : Interventional  (Clinical Trial)
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 : March 2011
Actual Primary Completion Date : February 2012
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Gout

Arm Intervention/treatment
Experimental: febuxostat group
Drug: febuxostat
Other Name: Adenuric, Uloric, Feburic

Active Comparator: allopurinol group
Drug: Allopurinol

Primary Outcome Measures :
  1. Proportion of subjects whose serum urate level decreases to < 6.0 mg/dL [ Time Frame: week 12 ]

Secondary Outcome Measures :
  1. Percent reduction in serum urate levels [ Time Frame: Baseline and at week 12 ]
  2. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01736514

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

Additional Information:
Responsible Party: Astellas Pharma Taiwan, Inc. Identifier: NCT01736514     History of Changes
Other Study ID Numbers: TMXALL-1001-TW
First Posted: November 29, 2012    Key Record Dates
Last Update Posted: October 29, 2014
Last Verified: October 2014

Keywords provided by Astellas Pharma Inc ( Astellas Pharma Taiwan, Inc. ):
xanthine oxidase inhibitor
Uric acid lowering drug

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