Dose-Response, Safety and Efficacy of Febuxostat in Subjects With Gout
NCT ID: NCT00174967
Last Updated: 2011-07-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
153 participants
INTERVENTIONAL
2001-01-31
2001-07-31
Brief Summary
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Detailed Description
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Currently allopurinol is the only xanthine oxidase inhibitor available. Allopurinol is the agent of choice for reduction of serum urate levels in patients with: uric acid overproduction; unresponsive or intolerant to uricosuric agents; impaired renal function; uric acid urolithiasis; or tophi.
Febuxostat (TMX-67) is a non-purine selective xanthine oxidase inhibitor being developed as an orally administered agent for management of hyperuricemia in patients with gout.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
TRIPLE
Study Groups
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Placebo QD
Placebo
Febuxostat placebo-matching tablets, orally, once daily for up to 4 weeks.
Febuxostat 40 mg QD
Febuxostat
Febuxostat 40 mg, tablets, orally, once daily for up to 4 weeks.
Febuxostat 80 mg QD
Febuxostat
Febuxostat 80 mg, tablets, orally, once daily for up to 4 weeks.
Febuxostat 120 mg QD
Febuxostat
Febuxostat 120 mg, tablets, orally, once daily for up to 4 weeks.
Interventions
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Placebo
Febuxostat placebo-matching tablets, orally, once daily for up to 4 weeks.
Febuxostat
Febuxostat 40 mg, tablets, orally, once daily for up to 4 weeks.
Febuxostat
Febuxostat 80 mg, tablets, orally, once daily for up to 4 weeks.
Febuxostat
Febuxostat 120 mg, tablets, orally, once daily for up to 4 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Must meet American College of Rheumatology criteria for gout.
* Must have adequate renal function (serum creatinine \<1.5 mg/dL).
* Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
Exclusion Criteria
* Alcohol consumption \>14/week
* Has a history of significant concomitant illness.
* Has active liver disease.
* Has a body mass index greater than 50 kilogram per meter² (kg/m²)
* Any other significant medical condition that would interfere with the treatment, safety or compliance with the protocol, as defined by the investigator.
18 Years
85 Years
ALL
No
Sponsors
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Takeda
INDUSTRY
Responsible Party
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Takeda Global Research & Development Center, Inc.
Principal Investigators
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Medical Director
Role: STUDY_CHAIR
Takeda
References
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Becker MA, Schumacher HR Jr, Wortmann RL, MacDonald PA, Palo WA, Eustace D, Vernillet L, Joseph-Ridge N. Febuxostat, a novel nonpurine selective inhibitor of xanthine oxidase: a twenty-eight-day, multicenter, phase II, randomized, double-blind, placebo-controlled, dose-response clinical trial examining safety and efficacy in patients with gout. Arthritis Rheum. 2005 Mar;52(3):916-23. doi: 10.1002/art.20935.
Colwell HH, Hunt BJ, Pasta DJ, Palo WA, Mathias SD, Joseph-Ridge N. Gout Assessment Questionnaire: Initial results of reliability, validity and responsiveness. Int J Clin Pract. 2006 Oct;60(10):1210-7. doi: 10.1111/j.1742-1241.2006.01104.x. Epub 2006 Aug 15.
Goldfarb DS, MacDonald PA, Hunt B, Gunawardhana L. Febuxostat in gout: serum urate response in uric acid overproducers and underexcretors. J Rheumatol. 2011 Jul;38(7):1385-9. doi: 10.3899/jrheum.101156. Epub 2011 May 15.
Related Links
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Other Identifiers
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U1111-1114-1992
Identifier Type: REGISTRY
Identifier Source: secondary_id
TMX-00-004
Identifier Type: -
Identifier Source: org_study_id