NCT00955981已完成2 期
Randomized, Double-Blind, Multicenter, Placebo-Controlled, Safety and Efficacy Study of RDEA594 Versus Placebo in the Treatment of Hyperuricemia in Patients With Gout
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 123
- 主要终点
- To compare the proportion of subjects whose serum urate (sUA) level is < 6.0 mg/dL after 28 days of dosing by treatment group.
研究概览
简要总结
To compare the proportion of subjects whose serum urate (sUA) level is < 6.0 mg/dL after 28 days of dosing by treatment group.
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
- •Male or post-menopausal or surgically sterile female.
- •18 - 75 years of age.
- •Hyperuricemic (i.e., screening sUA ≥8 mg/dL).
- •Meets criteria for the diagnosis of gout as per the American Rheumatism Association (ARA) Criteria for the Classification of Acute Arthritis of Primary Gout.
- •Willing and able to give informed consent and adhere to visit/protocol schedules (informed consent must be given before the first study procedure is performed).
- •Subjects entering the optional Extension Period must have successfully completed the Double-Blind Treatment Period and Follow-up Period within approximately 4 months and must not have experienced any serious adverse events considered possibly related to study drug.
排除标准
- •Classified as an overproducer of urine urate (Cur > 6.0 ml/min/1.73 m2 24- hour urine).
- •Consumes more than 14 drinks of alcohol per week (e.g., 1 drink = 5 oz [150 ml] of wine, 12 oz [360 ml] of beer, or 1.5 oz [45 ml] of hard liquor).
- •History or suspicion of drug abuse.
- •Documented history of or suspicion of kidney stones.
- •History of rheumatoid arthritis or other autoimmune disease.
- •Confirmed (positive serology to HIV1 and HIV 2) or suspected HIV infection.
- •Positive serology to HCV antibodies (Abs), and/or hepatitis B surface antigen (HBsAg).
- •History of malignancy, except treated non-melanomatous skin cancer or cervical dysplasia.
- •History of cardiac abnormalities, including abnormal and clinically relevant ECG changes such as bradycardia (sinus rate <45 bpm), complete left bundle branch block (LBBB), second or third degree heart block, intraventricular conduction delay with QRS duration >120 msec, symptomatic or asymptomatic arrhythmias with the exception of sinus arrhythmia, evidence of ventricular pre-excitation, frequent palpitations or syncopal episodes, heart failure, hypokalemia, family history of Long QT Syndrome, and/or family history of sudden death in an otherwise healthy individual between the ages of 1 and 30 years.
- •Any condition predisposing them to QT prolongation including pathological Q-wave (defined as Q-wave >40 msec or depth > 0.4-0.5 mV).
- •Any use of a concomitant medication that prolong the QT/QTc interval within the 14 days prior to Baseline (Day 0)
- •QT interval corrected for heart rate according to Fridericia (QTcF) > 450 msec at Screening or pre-dose at Baseline (Day 0)
- •Uncontrolled hypertension (above 150/95)
- •Inadequate renal function
- •Hemoglobin < 10 g/dL (males) or < 9 g/dL (females)
- •Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 x upper limit of normal (ULN)
- •Gamma glutamyl transferase (GGT) > 3 x ULN
- •Active peptic ulcer disease requiring treatment
- •History of xanthinuria, active liver disease, or hepatic dysfunction.
- •Requires therapy with any other urate-lowering medication, other than the study medication.
- •Requires long-term use of salicylates; diuretics; azathioprine; mercaptopurine; theophylline; intravenous colchicine; cyclosporine; cyclophosphamide; pyrazinamide; sulfamethoxazole; or trimethoprim
- •Taking medications known as enzyme inducers
- •Receiving a strong or moderate inhibitor of CYP3A4 or a P-gp inhibitor within 1 month prior to study drug dosing
- •Gout flare at screening that is resolved for less than one week prior to the first treatment with study medication (exclusive of chronic synovitis/ arthritis)
- •Female of childbearing potential
- •Received an investigational medication within 4 weeks prior to study medication administration
- •Previously participated in a clinical study involving RDEA806 or RDEA
- •Known hypersensitivity or allergy to RDEA594 or colchicine or any components in their formulations.
- •Body mass index (BMI) >40 kg/m
- •Taking greater than 1000 mg/day of Vitamin C.
- •Any other medical or psychological condition, which in the opinion of the Investigator and/or Medical Monitor, 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.
- •Inadequate renal function after completing the Double-Blind Treatment period prior to entering Extension Period.
- •Requiring treatment with prohibited medications noted in exclusion criteria numbers 20-23 after completing the Double-Blind Treatment Period prior to entering the Extension Period.
- •Clinically relevant medical event as determined by the investigator in consultation with medical monitor prior to entering the Extension Period.
研究组 & 干预措施
Matching placebo
Placebo Comparator
RDEA594 matching placebo qd for 28 days
干预措施: Placebo (Drug)
RDEA594 200 mg qd for 28 days
Experimental
干预措施: RDEA594 (Drug)
RDEA594 200 mg, 400 mg
Experimental
RDEA594 200 mg qd for 7 days followed by 400 mg qd for 21 days
干预措施: RDEA594 (Drug)
RDEA594 200 mg, 400 mg and 600 mg
Experimental
RDEA594 200 mg qd for 7 days followed by 400 mg qd for 7 days followed by 600 mg qd for 14 days
干预措施: RDEA594 (Drug)
结局指标
主要结局
To compare the proportion of subjects whose serum urate (sUA) level is < 6.0 mg/dL after 28 days of dosing by treatment group.
时间窗: 28 Days
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 weekly study visit during the Double-Blind Period.(28 Days)
- To evaluate the absolute and percent reduction from baseline in sUA levels at each weekly study visit.(28 Days and through extension)
- To evaluate the percentage change in 24-hour urine urate level (excretion) from baseline to Day 28.(28 Days and through extension)
- To evaluate the incidence of gout flares.(28 Days and through extension)
- To evaluate the safety and tolerability of RDEA594 in subjects with gout.(28 Days and through extension)
- To evaluate the proportion of subjects whose sUA level decreases to or is maintained at <6.0 mg/dL in the Open-Label Extension Period.(18 Months)
研究者
相似试验
已完成
2 期
Allopurinol Combination StudyGoutNCT01001338Ardea Biosciences, Inc.227
已完成
4 期
Microalbuminuria and Allopurinol in Type 1 DiabetesType 1 DiabetesDiabetic NephropathyNCT02829177Peter Rossing30
招募中
4 期
the Effects of Febuxostat Dose Tapering in Gout Patients Optimally Controlled for 5 Years or MoreGoutUric AcidNCT06622603Seoul National University Hospital59
已完成
2 期
Study of URC102 to Assess the Safety and Efficacy in Gout PatientsGoutHyperuricemiaNCT02557126JW Pharmaceutical76
已完成
2 期
Study of of URC102 to Assess the Efficacy and Safety in Gout PatientsGoutNCT04804111JW Pharmaceutical171