EUCTR2011-003756-39-DE进行中（未招募）不适用
A Phase 3 Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Assess the Efficacy and Safety of Lesinurad Monotherapy Compared to Placebo in Subjects with Gout and an Intolerance or Contraindication to a Xanthine Oxidase Inhibitor - Lesinurad Monotherapy in Gout Subjects Intolerant to Xanthine Oxidase Inhibitors (LIGHT)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 200
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
- •Subject is able to understand the study procedures, the risks involved and willing to provide written informed consent before the first study related activity.
- •Subject meets the diagnosis of gout as per the American Rheumatism Association Criteria for the Classification of Acute Arthritis of Primary Gout.
- •Subject has an sUA level = 6.5 mg/dL at the Screening and Day -7 Visits.
- •Subject must be able to take gout flare prophylaxis with colchicine or NSAID (including Cox-2 selective NSAID) ± PPI.
- •Subject has a history (either by medical record or subject interview) of intolerance or a contraindication to either allopurinol or febuxostat.
- •Body mass index (BMI) < 45 kg/m2.
- •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 193
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 7
排除标准
- •Subject who is taking any other approved urate-lowering medication that is indicated for the treatment of gout at the Screening Visit.
- •Subject with a documented history or suspicion of kidney stones.
- •Subject who is pregnant or breastfeeding.
- •Subject who consumes more than 14 drinks of alcohol per week (eg, 1 drink = 5 oz [150 mL] of wine, 12 oz [360 mL] of beer, or 1.5 oz [45 mL] of hard liquor).
- •Subject with a history or suspicion of drug abuse within the past 5 years.
- •Subject that requires or may require systemic immunosuppressive or immunomodulatory treatment.
- •Subject with a known or suspected human immunodeficiency virus (HIV) infection.
- •Subject with a positive test for active hepatitis B or hepatitis C infection.
- •Subject with a history of malignancy within the previous 5 years with the exception of non-melanoma skin cancer that has been treated with no evidence of recurrence, treated cervical dysplasia or treated in situ Grade 1 cervical cancer.
- •Subject within the last 12 months with: unstable angina, New York Heart Association class III or IV heart failure, myocardial infarction, stroke, or deep venous thrombosis; or subjects currently receiving anticoagulants.
- •Subject with uncontrolled hypertension.
- •Subject with an estimated creatinine clearance < 30 mL/min.
- •Subject with active peptic ulcer disease requiring treatment.
- •Subject with active liver disease or hepatic dysfunction.
- •Subject receiving chronic treatment with more than 325 mg salicylates per day.
- •Subject taking valpromide, progabide, or valproic acid.
- •Subject who has received an investigational therapy within 8 weeks or 5 half-lives (whichever is longer) prior to the Screening Visit.
- •Subject with 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.
研究者
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