EUCTR2012-001858-25-BG进行中（未招募）1 期
A multicentre, randomised, double-blind, parallel group study on the therapeutic efficacy and safety of Febuxostat (taken once daily) and the therapeutic efficacy and safety of Allopurinol on serum urate concentration in subjects suffering from hyperuricemia and gout. - Double-blind, randomised, multicenter, phase IV study in hyperuricemic gout subjects
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 330
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
入选标准
- •Subjects of both sexes suffering from hyperuricemia who had at least one episode of gout flare in their medical history
- •Sign and symptoms of gout flare have to be resolved at least 48 hours before enrolment or randomisation
- •Male or female subjects aged ?18 years
- •Subjects willing and able to give written informed consent
- •Subjects who have met, in their medical history, the preliminary criteria of the American Rheumatism Association for the classification of the acute arthritis of primary gout
- •Serum uric acid ? 8.0 milligrams per decilitre (mg/dL) at baseline
- •Subject willing to comply with the prophylaxis treatment
- •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 330
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 200
排除标准
- •Serum creatinine >1.5 mg/dL or calculated creatinine clearance < 60 milliliters per minutes (mL/min)
- •Pregnancy or lactation
- •Clinical evidence on screening visit of Ischaemic Heart Disease and/or Congestive Heart Failure
- •Concurrent therapy with Losartan
- •Concurrent therapy with urate lowering agents, azathioprine, 6-mercaptopurine, thiazide diuretics, theophylline or medications containing aspirin (>325 mg/day) or other salicylates
- •Concurrent therapy with colchicine, naproxene, indomethacin if not used for gout flares prophylaxis
- •Body Mass Index (BMI) >50 kilogram per square meter (kg/m²)
- •A history or presence of xanthinuria, active liver disease or hepatic dysfunction judged clinically relevant in the opinion of the Investigator
- •Other concurrent severe diseases (cancer, AIDS, thyroid disease etc.) judged clinically relevant in the opinion of the Investigator
- •Subjects with AST and ALT and total bilirubin more than 1.5 x Upper Normal Limit
- •Positive history for organ transplantation
- •Dementia, psychosis, alcoholism (> 350 g ethanol/week) or chronic abuse of medicines, drugs or psychoactive substances
- •Introduction of concurrent therapies among those not permitted and which cannot be suspended without harm to the subject
- •Hypersensitivity or contraindications to use of the product under study
- •Participation in other pharmacological clinical trials in the previous 4 months
- •Conditions which in the Investigator?s opinion may interfere with the study?s execution or due to which the subject should not participate for safety reasons
- •Risk of low subject cooperation
- •Females of childbearing potential not using adequate contraceptive precautions such as implants, injectables, combined oral contraceptives, intrauterine devices, sexual abstinence or vasectomised partner
- •Known lactose intolerance
研究者
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