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Safety and Efficacy of Oral Febuxostat in Subjects 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: NCT02082769
Recruitment Status : Completed
First Posted : March 10, 2014
Results First Posted : February 3, 2016
Last Update Posted : February 3, 2016
Qingdao Shengbang Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Xijing Hospital

Brief Summary:
The purpose of this study is to compare febuxostat allopurinol in subjects with gout.

Condition or disease Intervention/treatment Phase
Gout Drug: Febuxostat Drug: Allopurinol Phase 3

Detailed Description:
A randomized, double-blind, multicenter, allopurinol-controlled and parallel-assigned study comparing 40 mg, 80 mg of febuxostat, and allopurinol 300 mg in subjects with gout. Subjects will receive treatment for 24 weeks.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 504 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Multicenter, Allopurinol-Controlled Study Assessing the Safety and Efficacy of Oral Febuxostat in Subjects With Gout
Study Start Date : July 2011
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Gout
MedlinePlus related topics: Gout

Arm Intervention/treatment
Experimental: Febuxostat 40 mg QD
Febuxostat 40 mg, orally, once daily for up to 24 weeks
Drug: Febuxostat
Experimental: Febuxostat 80 mg QD
Febuxostat 80 mg, orally, once daily for up to 24 weeks
Drug: Febuxostat
Active Comparator: Allopurinol 100mg QD
Allopurinol 100mg, orally, three times daily for up to 24 weeks
Drug: Allopurinol

Primary Outcome Measures :
  1. Percentage of Subjects Whose Last Three Serum Urate Levels Are <6.0 Milligram Per Deciliter (mg/dL) [ Time Frame: Last 3 visits (any last 3 visits up to week 26) ]

Secondary Outcome Measures :
  1. Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Final Visit [ Time Frame: Final Visit (up to 26 weeks) ]

Other Outcome Measures:
  1. Absolute Change in the Serum Urate Level at the Final Visit Relative to Baseline [ Time Frame: Baseline and Final Visit (up to 26 weeks) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Hyperuricemia (serum urate ≥8.0 mg/dL) and gout by Chinese Rheumatism Association 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:

  • Pregnancy or lactation;
  • 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.

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): NCT02082769

Sponsors and Collaborators
Xijing Hospital
Qingdao Shengbang Pharmaceutical Co., Ltd.
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Principal Investigator: Shenren Chen, M.D. The Second Affiliated Hospital of Shantou University Medical College
Principal Investigator: Yangang Wang, M.D. The Affiliated Hospital of Qingdao University
Principal Investigator: Xiumei Liu, M.D. The First Affiliated Hospital of Shanxi Medical University
Principal Investigator: Hong Liu, M.D. First Affiliated Hospital of Guangxi Medical University
Principal Investigator: Yongde Peng, M.D. Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Principal Investigator: Jianqin Wang, M.D. LanZhou University
Principal Investigator: Jinying Lin, M.D. People's Hospital of Guangxi
Principal Investigator: Haiwang Ji, M.D. Shaanxi Provincial People's Hospital
Principal Investigator: Bin Liu, M.D. The First Hospital of Jilin University
Principal Investigator: Ying Lu, M.D. Zhejiang Provincial Tongde Hospital
Principal Investigator: Peng Liu, M.D. Guangxi Ruikang Hospital
Principal Investigator: Yonghong Zhang, M.D. Luoyang Orthopedic-Traumatological Hospital
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Xijing Hospital Identifier: NCT02082769    
Other Study ID Numbers: SFDA2010L04287
First Posted: March 10, 2014    Key Record Dates
Results First Posted: February 3, 2016
Last Update Posted: February 3, 2016
Last Verified: March 2014
Keywords provided by Xijing Hospital:
Uric Acid
Xanthine oxidase
Additional relevant MeSH terms:
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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