EUCTR2009-013055-30-CZ进行中（未招募）不适用
Randomized, Double-Blind, Multicenter, Placebo-Controlled, Safety and Efficacy Study of RDEA594 Versus Placebo in the Treatment of Hyperuricemia in Patients with Gout - Phase 2 Gout Dose Response Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 140
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Subject is male or post-menopausal or surgically sterile female.
- •2.Subject is 18 - 75 years of age.
- •3.Subject is hyperuricemic (i.e., screening sUA ?8 mg/dL).
- •4.Subject meets criteria for the diagnosis of gout as per the American Rheumatism Association (ARA) Criteria for the Classification of Acute Arthritis of Primary Gout.
- •5.Subject is 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).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Subject is classified as an overproducer of urine urate (Cur > 6.0 ml/min/1.73 m2 24- hour urine).
- •2.Subject who 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).
- •3.Subject with a history or suspicion of drug abuse.
- •4.Subject with a documented history of or suspicion of kidney stones.
- •5.Subject with a history of rheumatoid arthritis or other autoimmune disease.
- •6.Subject with confirmed (positive serology to HIV1 and HIV 2) or suspected HIV infection.
- •7.Subject with a positive serology to HCV antibodies (Abs), and/or hepatitis B surface antigen (HBsAg).
- •8.Subjects with a history of malignancy, except treated non-melanomatous skin cancer or cervical dysplasia.
- •9.Subject with a 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.
- •10.Subject with any condition predisposing them to QT prolongation including pathological Q-wave (defined as Q-wave >40 msec or depth > 0.4-0.5 mV).
- •11.Subject with any use of a concomitant medication that prolong the QT/QTc interval within the 14 days prior to Baseline (Day 0).
- •12.Subject with a QT interval corrected for heart rate according to Fridericia (QTcF) > 450 msec at Screening or pre-dose at Baseline (Day 0).
- •13.Subject with uncontrolled hypertension (above 150/95).
- •14.Subject with inadequate renal function [serum creatinine >1.5 mg/dL or creatinine clearance < 60 mL/min (by Cockroft-Gault formula)].
- •15.Subject with hemoglobin < 10 g/dL (males) or < 9 g/dL (females).
- •16.Subject with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 x upper limit of normal (ULN).
- •17.Subject with gamma glutamyl transferase (GGT) > 3 x ULN.
- •18.Subject with active peptic ulcer disease requiring treatment.
- •19.Subject with a history of xanthinuria, active liver disease, or hepatic dysfunction.
- •20.Subject requires therapy with any other urate-lowering medication, other than the study medication.
- •21.Subject requires long-term use of salicylates; diuretics; azathioprine; mercaptopurine; theophylline; intravenous colchicine; cyclosporine; cyclophosphamide; pyrazinamide; sulfamethoxazole; or trimethoprim.
- •22.Subjects taking medications known as enzyme inducers (see section 3.7 for listing).
- •23.Subject with a 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).
- •24.Subject is pregnant or breast feeding.
- •25.Subject who has received an investigational medication within 4 weeks prior to study medication administration.
- •26.Subject who previously participated in a clinical study involving RDEA806 or RDEA594.
- •27.Subject with a known hypersensitivity or allergy to RDEA594 or colchicine or any components in their formulations.
- •28.Subject with a body mass index (BMI) >40 kg/m2.
- •29.Subjects taking greater than 1000 mg/day of Vitamin C.
- •30.Subject with any other medi
研究者
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