A Phase 3, Randomized, Multicenter, Allopurinol and Placebo-Controlled Study Assessing the Safety and Efficacy of Oral Febuxostat in Subjects With Gout.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,072
- 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 and placebo, once daily (QD), in subjects with gout.
详细描述
A Phase 3 Study comparing 80 mg, 120 mg or 240 mg of febuxostat, allopurinol (300 mg for those with normal renal function and 100 mg for those with impaired renal function) and placebo administered once daily in subjects with gout.
Subjects will receive treatment for 28 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
- 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
- •Hyperuricemia (serum urate ≥8.0 mg/dL and gout by American 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 Cockroft and Gault formula.
排除标准
- •History of xanthinuria
- •Intolerance to allopurinol
- •Presence of renal calculi,
- •Alcohol intake of ≥ 14 drinks/week
- •Clinically significant medical condition
研究组 & 干预措施
Placebo QD
干预措施: Placebo (Drug)
Febuxostat 80 mg QD
干预措施: Febuxostat (Drug)
Febuxostat 120 mg QD
干预措施: Febuxostat (Drug)
Febuxostat 240 mg QD
干预措施: Febuxostat (Drug)
Allopurinol QD
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 28)
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 Whose Serum Urate Levels Are <6.0 mg/dL at Week 28(Week 28)
- Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Final Visit(Final Visit (up to 28 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 Final Visit(Baseline and Final Visit (up to 28 weeks))
- Percent Change in Primary Tophus Size at Week 28, as Determined by Physical Measurement in the Subset of Subjects With Palpable Tophi at the Screening Visit.(Baseline and Week 28)
- Percent Change in Primary Tophus Size at Final Visit, as Determined by Physical Measurement in the Subset of Subjects With Palpable Tophi at the Screening Visit.(Baseline and Final Visit (up to 28 weeks))
- Change in the Total Number of Tophi at Week 28 in the Subset of Subjects With Palpable Tophi at the Screening Visit.(Baseline and Week 28)
- Change in the Total Number of Tophi at Final Visit in the Subset of Subjects With Palpable Tophi at the Screening Visit(Final Visit (up to 28 weeks))
- Percentage of Subjects Requiring Treatment for a Gout Flare Between Weeks 8 and 28 of the Double-Blind Treatment Period.(Weeks 8 through 28)