A Phase 3, Randomized, Multicenter Study Comparing the Safety and Efficacy of Oral Febuxostat Versus Allopurinol in Subjects With Gout
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 760
- 主要终点
- Percentage of Subjects With the Last 3 Serum Urate Levels <6.0 Milligrams Per Deciliter (mg/dL)
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of febuxostat, once daily (QD), versus allopurinol in subjects with gout.
详细描述
This was a randomized, controlled, double-blind study of 52 weeks duration. Subjects receiving prior urate-lowering therapy underwent a 2-week washout period prior to randomization. Subjects were then randomized to one of three treatment groups: febuxostat 80 milligram (mg), febuxostat 120 mg, or allopurinol 300 mg. Naproxen (250 mg twice daily) or colchicine (0.6 mg once daily) was provided for prophylaxis of acute gout flares during the washout period and the first 8 weeks of double-blind treatment.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meeting the preliminary criteria of the American Rheumatism Association for the classification of the acute arthritis of primary gout.
- •Serum uric acid ≥ 8.0 milligrams per deciliter (mg/dL) at Baseline
排除标准
- •Serum creatinine >1.5 mg/dL
- •Calculated creatinine clearance of <50 milliliters per minutes (mL/min)
- •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 xanthinuria, active liver disease, or hepatic dysfunction;
- •A history of alcohol abuse or intake of 14 or more alcohol-containing drinks/week.
研究组 & 干预措施
Febuxostat 80 mg QD
干预措施: Febuxostat (Drug)
Febuxostat 120 mg QD
干预措施: Febuxostat (Drug)
Allopurinol 300 mg QD
干预措施: Allopurinol (Drug)
结局指标
主要结局
Percentage of Subjects With the Last 3 Serum Urate Levels <6.0 Milligrams Per Deciliter (mg/dL)
时间窗: Last 3 Visits (up to 52 weeks)
Each subject's serum urate at the last 3 visits determined the subject's response for the primary efficacy variable. A subject who prematurely discontinued without least 3 postbaseline serum urate levels was considered a nonresponder; if at least 3 serum urate were obtained postbaseline, those 3 visits were used. The last 3 visits used may have differed for each subject.
次要结局
- Percentage of Subjects With Serum Urate <6.0 mg/dL at Week 28 Visit(Week 28)
- Percentage of Subjects With Serum Urate <6.0 mg/dL at Week 52 Visit(Week 52)
- Percentage of Subjects With Serum Urate <6.0 mg/dL at Final Visit(Final Visit (up to 52 weeks))
- Percent Change From Baseline in Serum Urate Levels at Week 28.(Baseline and Week 28)
- Percent Change From Baseline in Serum Urate Levels at Week 52.(Baseline and Week 52)
- Percent Change From Baseline in Serum Urate Levels at Final Visit(Baseline and Final Visit (up to 52 weeks))
- Percent Change From Baseline in Tophus Size at Week 28, as Determined by Physical Measurement, in Subjects With a Palpable Primary Tophus at Screening.(Baseline and Week 28)
- Percent Change From Baseline in Tophus Size at Week 52, as Determined by Physical Measurement, in Subjects With a Palpable Primary Tophus at Screening.(Baseline and Week 52)
- Percent Change From Baseline in Tophus Size at Final Visit, as Determined by Physical Measurement, in Subjects With a Palpable Primary Tophus at Screening.(Baseline and Final Visit (up to 52 weeks))
- Change From Baseline in Total Number of Tophi at Week 28 in Subjects With Palpable Tophi at Screening.(Baseline and Week 28)
- Change From Baseline in Total Number of Tophi at Week 52 in Subjects With Palpable Tophi at Screening.(Baseline and Week 52)
- Change From Baseline in Total Number of Tophi at Final Visit in Subjects With Palpable Tophi at Screening.(Baseline and Final Visit (up to 52 weeks))
- Percentage of Subjects Requiring Treatment for Gout Flares Between Weeks 8 and 52.(Weeks 8 through 52)