A Phase 3, Randomized, Multicenter, Double-Blind, Allopurinol-Controlled Study Assessing the Efficacy and Safety 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
- 2,269
- 主要终点
- Percentage of Subjects Whose Serum Urate Level is <6.0 Milligrams Per Deciliter (mg/dL) at the Final Visit.
研究概览
简要总结
The purpose of this study is to compare the efficacy and safety of febuxostat, once Daily (QD), to allopurinol in subjects with hyperuricemia and gout.
详细描述
Renal impairment is common in subjects with gout, with the prevalence ranging from 50% to 70%. This population represents an unmet medical need as uricosuric drugs are contraindicated in these patients, and the only available treatment, allopurinol, may have to be dose reduced to avoid overt side effects.
Febuxostat (TMX-67) is a non-purine selective xanthine oxidase inhibitor being developed as an orally administered agent for management of hyperuricemia in patients with gout.
Treatment duration will be 6 months.
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
- •Has one or more of the American Rheumatism Association criteria for the diagnosis of gout.
- •Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
- •Must have a serum urate level greater than or equal to 8.0 milligram per deciliter (mg/dL).
排除标准
- •Have a severe, unstable, or life threatening medical condition that would likely prevent them from completing this study.
- •Has a known body reaction to febuxostat, allopurinol, naproxen, any other non-steroidal anti-inflammatory drug (NSAID), aspirin, lansoprazole, colchicine, or any components in their formulation.
- •History of xanthinuria.
- •Alcohol consumption greater than 14/week.
- •History of significant concomitant illness.
- •Active liver or peptic ulcer disease.
- •Has rheumatoid arthritis requiring treatment.
- •Has estimated creatinine clearance less than 30 milliliter per minute (mL/min) calculated using the Cockcroft-Gault formula corrected for ideal body weight.
- •Requires therapy with any other urate-lowering drug other than the study drug; long-term use of NSAIDs and COX-2 inhibitors; salicylates; thiazide diuretics; losartan; azathioprine; mercaptopurine; theophylline; intravenous (IV) colchicine; cyclosporine; cyclophosphamide; pyrazinamide; sulfamethoxazole;trimethoprim.
研究组 & 干预措施
Febuxostat 40 mg QD
干预措施: Febuxostat (Drug)
Febuxostat 80 mg QD
干预措施: Febuxostat (Drug)
Allopurinol 200 mg or 300 mg QD
(dependent on renal function)
干预措施: Allopurinol (Drug)
结局指标
主要结局
Percentage of Subjects Whose Serum Urate Level is <6.0 Milligrams Per Deciliter (mg/dL) at the Final Visit.
时间窗: Last Visit on treatment (up to 6 months)
The percentage of subjects whose serum urate level was \<6.0 mg/dL at the Final Visit was summarized. The Final Visit was the last visit at which a serum urate value was collected.
次要结局
- Percentage of Renal Impairment Subjects Whose Final Visit Serum Urate Level is <6.0 mg/dl(Last Visit on treatment (up to 6 months))
- Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Month 2 Visit.(Month 2)
- Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Month 4 Visit.(Month 4)
- Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Month 6 Visit.(Month 6)
- Percentage of Subjects Whose Serum Urate Levels Are <5.0 mg/dL at Month 2 Visit.(Month 2)
- Percentage of Subjects Whose Serum Urate Levels Are <5.0 mg/dL at Month 4 Visit.(Month 4)
- Percentage of Subjects Whose Serum Urate Levels Are <5.0 mg/dL at Month 6 Visit.(Month 6)
- Percentage of Subjects Whose Serum Urate Levels Are <5.0 mg/dL at Final Visit.(Last Visit on treatment (up to 6 months))
- Percentage of Subjects Whose Serum Urate Levels Are <4.0 mg/dL at Month 2 Visit(Month 2)
- Percentage of Subjects Whose Serum Urate Levels Are <4.0 mg/dL at Month 4 Visit(Month 4)
- Percentage of Subjects Whose Serum Urate Levels Are <4.0 mg/dL at Month 6 Visit(Month 6)
- Percentage of Subjects Whose Serum Urate Levels Are <4.0 mg/dL at Final Visit(Last Visit on treatment (up to 6 months))
- Mean Percent Change From Baseline in Serum Urate Levels at Month 2 Visit.(Baseline and Month 2)
- Mean Percent Change From Baseline in Serum Urate Levels at Month 4 Visit(Baseline and Month 4)
- Mean Percent Change From Baseline in Serum Urate Levels at Month 6 Visit.(Baseline and Month 6)
- Mean Percent Change From Baseline in Serum Urate Levels at Final Visit.(Baseline and Last Visit on treatment (up to 6 months))