EUCTR2009-014660-19-GB进行中（未招募）不适用
Randomized, Double-Blind, Multicenter, Placebo-Controlled, Combination Study to Evaluate the Safety, Efficacy and Potential Pharmacokinetic Interaction of RDEA594 and Allopurinol in Gout Patients with an Inadequate Hypouricemic Response with Standard Doses of Allopurinol - Phase 2 Allopurinol Combination Study - Open Label Extension Period
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 216
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 a post-menopausal or surgically sterile female. (Post-menopausal is generally defined as a period of twelve (12) consecutive months of amenorrhoea. In women under 55 years of age whose menopausal status is in question, a follicle-stimulating hormone (FSH) level of >40 mIU/ml or an oestrogen deficiency of < 30 pg/m or a negative oestrogen test can confirm they are post-menopausal.)
- •2.Subject is 18 - 80 years of age.
- •3.Subject has been taking allopurinol as the sole urate lowering therapy for hyperuricemia for at least 6 weeks at a dose between 200 mg - 600 mg per day without an adequate response (i.e., sUA level not less than 6.0 mg/dL on at least 2 occasions at least approximately 2 weeks apart, which can include the screening visit).
- •4.Subject has a sUA level = 6 mg/dL at screening.
- •5.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.
- •6.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).
- •7. Subjects entering the optional Double-Blind Extension Period must have completed 28 days of dosing (+/- 3 days) in the Double-Blind Treatment Period and the Day 42 Visit in the Follow-up Period within 4 months and must not have experienced any serious adverse events considered possibly related to study drug.
- •8. Subjects entering the optional Open-Label Extension Period must continue to be
- •compliant with the protocol through Week 44 of the Double-Blind Extension Period
- •and must not have experienced any serious adverse events considered possibly related to study drug.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 32
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •1.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).
- •2.Subject with a history or suspicion of drug abuse.
- •3.Subject with a history of documented or suspected kidney stones.
- •4.Subject has rheumatoid arthritis or other autoimmune disease requiring treatment.
- •5.Subject with documented or suspicion of HIV infection.
- •6.Subject with a positive serology to HCV antibodies (Abs), and/or hepatitis B surface antigen (HBsAg).
- •7.Subject with a history of malignancy within 5 years prior to the first dose of study medication, other than non-melanomatous skin cancer or cervical dysplasia.
- •8.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 otherwise healthy individual between the ages of 1 and 30 years.
- •9.Subject with any condition predisposing to QT prolongation including pathological Q-wave (defined as Q-wave >40 msec or depth > 0.4-0.5 mV).
- •10.Subject with any use of concomitant medications that prolong the QT/QTc interval within the 14 days prior to Baseline (Day 1).
- •11.Subject with a QT interval corrected for heart rate according to Fridericia (QTcF) > 450 msec at Screening or pre-dose at Baseline (Day 1).
- •12.Subject with uncontrolled hypertension (above 150/95).
- •13.Subject with inadequate renal function [serum creatinine >1.5 mg/dL or creatinine clearance < 60 mL/min (by Cockroft-Gault formula)].
- •14.Subject with a hemoglobin < 10 g/dL (males) or < 9 g/dL (females).
- •15.Subject with an alanine aminotransferase (ALT) or aspartate aminotransferase (AST) 2.5 x upper limit of normal (ULN).
- •16.Subject with a gamma glutamyl transferase (GGT) > 3 x ULN.
- •17.Subject with active peptic ulcer disease requiring treatment.
- •18.Subject with a history of xanthinuria, active liver disease, or hepatic dysfunction.
- •19.Subject requires therapy with any other urate-lowering medication, other than the study medications.
- •20.Subject requires long-term use of salicylates above 100 mg per day; thiazide diuretics (except low-dose hydrochlorothiazide); losartan; azathioprine; mercaptopurine; theophylline; intravenous colchicine; cyclosporine; cyclophosphamide; pyrazinamide; sulfamethoxazole; or trimethoprim.
- •21.Subject taking medications known as enzyme inducers.
- •22.Subject reports receiving a strong or moderate inhibitor of CYP3A4 or a P-gp inhibitor within 1 month prior to study drug dosing, due to potential interactions with colchicine.
- •23.Subject with an acute gout flare (exclusive of chronic synovitis/ arthritis) during the Screening-Period that has not resolved one week prior to the Baseline Visit (Day 0).
- •24.Subject is pregnant or breast feeding.
- •25.Subject who has received an investigational medication within 4 weeks prior to the screening visit for this study.
- •26.Subject who previously participated in a clinical study involving RDEA806 or RDEA594.
- •27.Subject with known hypersen
研究者
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