Clinical trial NCT02082769: Safety and Efficacy of Oral Febuxostat in Subjects With Gout
Official title: A Phase 3, Randomized, Multicenter, Allopurinol-Controlled Study Assessing the Safety and Efficacy of Oral Febuxostat in Subjects With Gout
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gout
Keywords: Gout
Uric Acid
Xanthine oxidase
Febuxostat
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
Collaborators: name: Qingdao Shengbang Pharmaceutical Co., Ltd.
First posted: 2014-03-10
Enrollment: 504
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Subjects Whose Last Three Serum Urate Levels Are <6.0 Milligram Per Deciliter (mg/dL)
timeFrame: Last 3 visits (any last 3 visits up to week 26)
Secondary outcomes:
measure: Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Final Visit
timeFrame: Final Visit (up to 26 weeks)
Other outcomes:
measure: Absolute Change in the Serum Urate Level at the Final Visit Relative to Baseline
timeFrame: Baseline and Final Visit (up to 26 weeks)
Locations:
Study officials:
affiliation: Second Affiliated Hospital of Shantou University Medical College
name: Shenren Chen, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: The Affiliated Hospital of Qingdao University
name: Yangang Wang, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital of Shanxi Medical University
name: Xiumei Liu, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: First Affiliated Hospital of Guangxi Medical University
name: Hong Liu, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
name: Yongde Peng, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Lanzhou University Second Hospital
name: Jianqin Wang, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: People's Hospital of Guangxi Zhuang Autonomous Region
name: Jinying Lin, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Shaanxi Provincial People's Hospital
name: Haiwang Ji, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Hospital of Jilin University
name: Bin Liu, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Zhejiang Provincial Tongde Hospital
name: Ying Lu, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Guangxi Ruikang Hospital
name: Peng Liu, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Luoyang Orthopedic-Traumatological Hospital
name: Yonghong Zhang, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.