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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Taiwan, Inc. )
ClinicalTrials.gov Identifier:
NCT01736514
First received: November 27, 2012
Last updated: NA
Last verified: November 2012
History: No changes posted
  Purpose

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
Gout
 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:

MedlinePlus related topics: Gout
U.S. FDA Resources

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
oral
 Drug: febuxostat
oral
Other Name: Adenuric, Uloric, Feburic
Active Comparator: allopurinol group
oral
 Drug: Allopurinol
oral

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01736514

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

No publications provided

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: November 27, 2012
Health Authority: Taiwan: Department of Health

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

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

ClinicalTrials.gov processed this record on May 16, 2013