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Safety and Efficacy of Oral Febuxostat in Subjects With Gout

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ClinicalTrials.gov Identifier: NCT02082769
Recruitment Status : Completed
First Posted : March 10, 2014
Results First Posted : February 3, 2016
Last Update Posted : February 3, 2016
Sponsor:
Collaborator:
Qingdao Shengbang Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Xijing Hospital

Tracking Information
First Submitted Date  ICMJE March 6, 2014
First Posted Date  ICMJE March 10, 2014
Results First Submitted Date  ICMJE May 11, 2015
Results First Posted Date  ICMJE February 3, 2016
Last Update Posted Date February 3, 2016
Study Start Date  ICMJE July 2011
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 30, 2015)
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) ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 6, 2014)
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 28) ]
Change History Complete list of historical versions of study NCT02082769 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 30, 2015)
Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Final Visit [ Time Frame: Final Visit (up to 26 weeks) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 6, 2014)
Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Final Visit [ Time Frame: Final Visit (up to 28 weeks) ]
Current Other Pre-specified Outcome Measures
 (submitted: December 30, 2015)
Absolute Change in the Serum Urate Level at the Final Visit Relative to Baseline [ Time Frame: Baseline and Final Visit (up to 26 weeks) ]
Original Other Pre-specified Outcome Measures
 (submitted: March 6, 2014)
Percent Change From Baseline in Serum Urate Levels at Final Visit [ Time Frame: Baseline and Final Visit (up to 28 weeks) ]
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Oral Febuxostat in Subjects With Gout
Official Title  ICMJE A Phase 3, Randomized, Multicenter, Allopurinol-Controlled Study Assessing the Safety and Efficacy of Oral Febuxostat in Subjects With Gout
Brief Summary The purpose of this study is to compare febuxostat allopurinol in subjects with gout.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Gout
Intervention  ICMJE
  • Drug: Febuxostat
  • Drug: Allopurinol
Study Arms  ICMJE
  • Experimental: Febuxostat 40 mg QD
    Febuxostat 40 mg, orally, once daily for up to 24 weeks
    Intervention: Drug: Febuxostat
  • Experimental: Febuxostat 80 mg QD
    Febuxostat 80 mg, orally, once daily for up to 24 weeks
    Intervention: Drug: Febuxostat
  • Active Comparator: Allopurinol 100mg QD
    Allopurinol 100mg, orally, three times daily for up to 24 weeks
    Intervention: Drug: Allopurinol
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 30, 2015)
504
Original Actual Enrollment  ICMJE
 (submitted: March 6, 2014)
522
Actual Study Completion Date  ICMJE October 2013
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02082769
Other Study ID Numbers  ICMJE SFDA2010L04287
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Xijing Hospital
Study Sponsor  ICMJE Xijing Hospital
Collaborators  ICMJE Qingdao Shengbang Pharmaceutical Co., Ltd.
Investigators  ICMJE
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. 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
PRS Account Xijing Hospital
Verification Date March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP