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Completed

NCT Number: NCT01736514

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

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.

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Key information

Conditions

Gout Arthritis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Crystal Arthropathies Genetic Diseases, Inborn Joint Diseases Metabolic Diseases Metabolism, Inborn Errors Musculoskeletal Diseases Nutritional and Metabolic Diseases Purine-Pyrimidine Metabolism, Inborn Errors Rheumatic Diseases

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Kaohsiung City, Taiwan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Febuxostat

Drug

oral

Other names: Adenuric, Uloric, Feburic

Allopurinol

Drug

oral

Primary outcomes

  1. Proportion of subjects whose serum urate level decreases to < 6.0 mg/dL

    Time frame: week 12

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Astellas Pharma Taiwan, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Nov 29, 2012
Registry last updated
Oct 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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