Safety and Efficacy of Oral Febuxostat in Subjects With Gout
NCT ID: NCT02082769
Last Updated: 2016-02-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
504 participants
INTERVENTIONAL
2011-07-31
2013-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Febuxostat 40 mg QD
Febuxostat 40 mg, orally, once daily for up to 24 weeks
Febuxostat
Febuxostat 80 mg QD
Febuxostat 80 mg, orally, once daily for up to 24 weeks
Febuxostat
Allopurinol 100mg QD
Allopurinol 100mg, orally, three times daily for up to 24 weeks
Allopurinol
Interventions
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Febuxostat
Allopurinol
Eligibility Criteria
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Inclusion Criteria
* Renal function defined as a serum creatinine level of \< 2.0 mg/dL and creatinine clearance of \> 20 milliliters per minute (mL/min) by Cockcroft and Gault formula;
* No gout flare 2 weeks beforehand during 2-week screening period.
Exclusion Criteria
* Concurrent therapy with urate lowering agents, azathioprine, 6-mercaptopurine, thiazide diuretics, or medications containing aspirin (\>325 mg) or other salicylates;
* Body Mass Index (BMI) \>50 kilogram per meter²(kg/m²);
* A history of active liver disease, or hepatic dysfunction;
* A history of bronchial asthma;
* A history of renal calculi or thyroid disease;
* Secondary gout Joint diseases induced by rheumatoid arthritis, psoriatic arthritis and bone tumor;
* Intolerance to allopurinol and Ibuprofen;
* Alcohol intake of ≥ 14 drinks/week;
* Clinically significant medical condition.
18 Years
70 Years
ALL
No
Sponsors
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Qingdao Shengbang Pharmaceutical Co., Ltd.
INDUSTRY
Xijing Hospital
OTHER
Responsible Party
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Principal Investigators
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Shenren Chen, M.D.
Role: PRINCIPAL_INVESTIGATOR
Second Affiliated Hospital of Shantou University Medical College
Yangang Wang, M.D.
Role: PRINCIPAL_INVESTIGATOR
The Affiliated Hospital of Qingdao University
Xiumei Liu, M.D.
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital of Shanxi Medical University
Hong Liu, M.D.
Role: PRINCIPAL_INVESTIGATOR
First Affiliated Hospital of Guangxi Medical University
Yongde Peng, M.D.
Role: PRINCIPAL_INVESTIGATOR
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Jianqin Wang, M.D.
Role: PRINCIPAL_INVESTIGATOR
Lanzhou University Second Hospital
Jinying Lin, M.D.
Role: PRINCIPAL_INVESTIGATOR
People's Hospital of Guangxi Zhuang Autonomous Region
Haiwang Ji, M.D.
Role: PRINCIPAL_INVESTIGATOR
Shaanxi Provincial People's Hospital
Bin Liu, M.D.
Role: PRINCIPAL_INVESTIGATOR
The First Hospital of Jilin University
Ying Lu, M.D.
Role: PRINCIPAL_INVESTIGATOR
Zhejiang Provincial Tongde Hospital
Peng Liu, M.D.
Role: PRINCIPAL_INVESTIGATOR
Guangxi Ruikang Hospital
Yonghong Zhang, M.D.
Role: PRINCIPAL_INVESTIGATOR
Luoyang Orthopedic-Traumatological Hospital
References
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Xu S, Liu X, Ming J, Chen S, Wang Y, Liu X, Liu H, Peng Y, Wang J, Lin J, Ji H, Liu B, Lu Y, Liu P, Zhang Y, Ji Q. A phase 3, multicenter, randomized, allopurinol-controlled study assessing the safety and efficacy of oral febuxostat in Chinese gout patients with hyperuricemia. Int J Rheum Dis. 2015 Jul;18(6):669-78. doi: 10.1111/1756-185X.12648. Epub 2015 May 27.
Other Identifiers
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SFDA2010L04287
Identifier Type: -
Identifier Source: org_study_id
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