NCT02082769已完成3 期
A Phase 3, Randomized, Multicenter, Allopurinol-Controlled Study Assessing the Safety and Efficacy of Oral Febuxostat in Subjects With Gout
Xijing Hospital0 个研究点目标入组 504 人开始时间: 2011年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 504
- 主要终点
- Percentage of Subjects Whose Last Three Serum Urate Levels Are <6.0 Milligram Per Deciliter (mg/dL)
研究概览
简要总结
The purpose of this study is to compare febuxostat allopurinol in subjects with gout.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Febuxostat 40 mg QD
Experimental
Febuxostat 40 mg, orally, once daily for up to 24 weeks
干预措施: Febuxostat (Drug)
Febuxostat 80 mg QD
Experimental
Febuxostat 80 mg, orally, once daily for up to 24 weeks
干预措施: Febuxostat (Drug)
Allopurinol 100mg QD
Active Comparator
Allopurinol 100mg, orally, three times daily for up to 24 weeks
干预措施: Allopurinol (Drug)
结局指标
主要结局
Percentage of Subjects Whose Last Three Serum Urate Levels Are <6.0 Milligram Per Deciliter (mg/dL)
时间窗: Last 3 visits (any last 3 visits up to week 26)
次要结局
- Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Final Visit(Final Visit (up to 26 weeks))
研究者
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