Low-dose Colchicine With or Without Stepwise Dose Titration of Febuxostat for Flare Prophylaxis in Patients With Gout and Hyperuricemia During the Initial Phase of Urate-lowering Therapy: an Open-label Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- The incidence rate of gout flare during the first 12 weeks.
研究概览
简要总结
The purpose of this study is to compare the incidence rate of gout flare for subjects with gout and hyperuricemia treated by two different starting doses of febuxostat.
详细描述
A prospective randomized open-label study comparing dose titration group (stepwise dose titration of febuxostat and low-dose colchicine) and standard treatment group (fixed dose febuxostat and low-dose colchicine) in the subjects with gout and hyperuricemia. The incidence rate of gout flare will be compared between two groups during the first 12 week of febuxostat 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
- None
入排标准
- 年龄范围
- 20 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hyperuricemia (serum urate ≥7.0 mg/dL and gout by 1977 American College of Rheumatology Criteria
- •Acute gout attack during the last 12 months
排除标准
- •Acute gout attack in the last 2 weeks
- •Urate-lowering therapy in the last 4 weeks
- •Secondary hyperuricemia
- •Creatinine ≥2.0 mg/dL
- •AST or ALT ≥2x upper limits of normal
- •Heart failure (NYHA III-IV)
- •Hypersensitivity to colchicine, NSAID or febuxostat
- •Use of NSAID, glucocorticoid, cyclosporine, clarithromycin, mercaptopurine, azathioprine, pyrazinamide, ethambutol, chemotherapy, tacrolimus, losartan, and fenofibrate
- •Inability to comply with the protocol requirements
- •The judgement of the investigator that the patient was not an appropriate candidate
研究组 & 干预措施
Dose titration group
Stepwise dose titration of febuxostat and low-dose colchicine
干预措施: Stepwise dose titration of febuxostat and low-dose colchicine (Drug)
Standard treatment group
Fixed dose febuxostat and low-dose colchicine
干预措施: Fixed dose febuxostat and low-dose colchicine (Drug)
结局指标
主要结局
The incidence rate of gout flare during the first 12 weeks.
时间窗: 12 weeks
The percentage of the patients suffered from gout flare during the first 12 weeks.
次要结局
- The percentage of patients with serum urate <6.0mg/dL in 12, 24 weeks(12, 24 weeks)
- The number of gout flares per patient during the first 12 weeks(12 weeks)
- The number of gout flares per patient during the second 12 weeks(12 weeks)