NCT00741442已完成2 期
Randomized, Double-Blind, Multicenter,Placebo-Controlled, Dose Ranging, Efficacy and Safety Study of RDEA806 in Hyperuricemic Subjects With Symptomatic Gout
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 3
- 主要终点
- To compare the proportion of subjects whose serum uric acid (sUA) level is <6.0 mg/dL following 4 weeks of continuous treatment with RDEA806.
研究概览
简要总结
The purpose of this study is to determine whether RDEA806 is effective in the treatment of hyperuricemia in gout patients.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is hyperuricemic: screening serum uric acid ≥8 mg/dL.
- •Patient meets one or more of the 1977 ARA criteria for the diagnosis of gout.
- •Patient is willing and able to give informed consent and adhere to visit/protocol schedules
- •All female subjects of child-bearing potential must agree to use a barrier method of birth control (e.g. condom, diaphragm or cap).
排除标准
- •Consumes more than 14 drinks of alcohol per week.
- •History or suspicion of drug abuse.
- •History of kidney stones, rheumatoid arthritis or other autoimmune disease, significant cardiac dysfunction.
- •Diabetes Mellitus requiring treatment
- •Confirmed or suspected HIV-1 infection.
- •Malignancy, except treated non-melanomatous skin cancer and cervical dysplasia.
- •Uncontrolled hypertension.
- •Inadequate renal function.
- •Hemoglobin < 8 g/dL (males) or < 7 g/dL (females).
- •ALT, AST , or GGT 2 x ULN
- •Active peptic ulcer disease.
- •Requires long-term use of salicylates; thiazide diuretics; losartan; azathioprine; mercaptopurine; theophylline; IV colchicine; cyclosporine; cyclophosphamide; pyrazinamide; sulfamethoxazole; trimethoprim.
- •Pregnant or breast feeding.
- •Use of an investigational drug within 4 weeks prior to study drug administration.
- •Known hypersensitivity or allergy to RDEA806 or colchicine or any components in their formulations.
- •Any other medical or psychological condition which, in the opinion of the investigator, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements, or to complete the study.
- •History of cardiac abnormalities including abnormal and clinically relevant ECG changes.
- •Conditions predisposing to QT prolongation.
- •Any use of concomitant medications that prolong the QT/QTc interval within 14 days prior to Day
- •Subjects with a QTcF interval >450 milliseconds at screening or on Day -1 or at pre-dose (Hour 0) on Day 1.
研究组 & 干预措施
1
Experimental
RDEA806 400 mg qd
干预措施: RDEA806 (Drug)
3
Experimental
RDEA806 400 mg bid
干预措施: RDEA806 (Drug)
2
Placebo Comparator
Placebo QD
干预措施: Placebo (Drug)
4
Placebo Comparator
Placebo BID
干预措施: Placebo (Drug)
结局指标
主要结局
To compare the proportion of subjects whose serum uric acid (sUA) level is <6.0 mg/dL following 4 weeks of continuous treatment with RDEA806.
时间窗: 4 weeks
次要结局
- To evaluate the proportion of subjects whose sUA levels are <6.0 mg/dL, <5.0 mg/dL and <4.0 mg/dL, at each visit.(4 weeks)
- To evaluate the absolute and percent reduction from baseline in sUA levels(4 weeks)
- To evaluate percent change in 24-hour urine uric acid level(4 weeks)
研究者
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