NCT04069325Unknown不适用
Efficacy and Safety of Simiaowan in Prevention of Acute Flares in Chronic Gout Patients Initiating Febuxostat Therapy：a Randomized Controlled Trial
Guang'anmen Hospital of China Academy of Chinese Medical Sciences1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2019年9月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Proportion of subjects experiencing ≥ 1 gout flare within 12 weeks
研究概览
简要总结
The aim of this study is to evaluate the efficacy and safety of simiaowan in prevention of acute flares in chronic gout patients initiating febuxostat therapy.
详细描述
The study is a multicenter, randomized, double-blind, placebo-controlled, 12-week trial. To determine whether oral simiaowan at standard clinical doses (6g twice daily), compared to placebo, can reduce the incidence of acute gout flares and decrease the serum uric acid level.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, 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 female subjects aged 18 to 75 years (time of get informed consent)
- •Meet the American College of Rheumatology/The European League Against Rheumatism criteria (2015) for the classification of acute arthritis of primary gout
- •Pain Visual Analogue Scale Score (VAS) ≤ 3 at screening
- •Serum uric acid ≥7 mg/dL (420μmol/L) at screening
- •Self-reported history of at least 2 gout flares within 12 months prior to screening
- •Normal electrocardiogram (ECG), or no clinical significant at screening
- •Be capable of understanding and complying with protocol requirements
排除标准
- •Occurrence of an acute gout flare ongoing at screening or within 2 weeks prior to screening
- •Known or suspected of secondary hyperuricemia (e.g. due to renal disorder, hematological disorder, drugs, radiotherapy, chemotherapy or organ transplant)
- •Use of colchicine, allopurinol, probenecid, benzbromarone, febuxostat or history of intra-articular steroid injection within 4 weeks prior to screening
- •Use of glucocorticoids, nonsteroidal antiinflammatory drugs (NSAIDs), or cyclooxygenase-2 (COX-2) inhibitors within 1 week prior to screening
- •History of stroke, transient ischemic attack (TIA), acute myocardial infarction (MI), heart failure (NYHA Class II-IV), coronary intervention procedure (including but not limited to angioplasty, stent placement, coronary revascularization) prior to screening
- •History of gastrointestinal (GI) bleeding, peptic ulcer disease prior to screening
- •History of malignancy and/or mental disorder prior to screening
- •Active infection with hepatitis B, hepatitis C, or has aspartate transaminase (AST), alanine aminotransferase (ALT) or gamma-glutamyl transpeptidase (GGT) values ≥1.2 times the upper limit of normal (×ULN) during the screening period
- •Presence of severe renal function impairment, or has serum creatinine (sCr) values ≥1.2 (×ULN) during the screening period
- •History of allergy or intolerance to febuxostat, diclofenac sodium, simiaowan and/or the placebo
- •History of aspirin-induced asthma, or any other form of allergy to aspirin and other NSAIDs
- •Other (non-gout) chronic arthritis, acute inflammatory arthritis, autoimmune diseases with arthritis at screening
- •Being treated with simiaowan at screening
- •Being treated with azathioprine, mercaptopurine, theophylline, cytotoxic agents at screening
- •Diagnosis of drug or alcohol dependence or abuse or any condition requiring chronic daily use of pain medication
- •Pregnant or nursing, or planning to become pregnant or father a child within 3 months after receiving the last dose of study drug
- •Subjects who participated in another clinical study or clinical trial within 3 months prior to screening
- •Any other condition(s) that will compromise the safety of the patient, prevent compliance with the study protocol, or compromise the quality of the clinical study, as judged by the investigator
研究组 & 干预措施
simiaowan 6g + febuxostat 40mg
Experimental
干预措施: febuxostat (Drug)
simiaowan 6g + febuxostat 40mg
Experimental
干预措施: simiaowan (Drug)
placebo 6g + febuxostat 40mg
Placebo Comparator
干预措施: placebo (Drug)
placebo 6g + febuxostat 40mg
Placebo Comparator
干预措施: febuxostat (Drug)
结局指标
主要结局
Proportion of subjects experiencing ≥ 1 gout flare within 12 weeks
时间窗: Day 1 to Week 12
Proportion of subjects in each group who experiencing at least 1 new gout flare during the 12 weeks study treatment period.
次要结局
- The incidence of new gout flares within 12 weeks in the simiaowan group compared to the placebo group(Day 1 to Week 12)
- Proportion of subjects in each group achieving serum uric acid concentration≤ 7 mg/dL (420μmol/L)(Week4, Week 8 and Week 12)
- Proportion of subjects experiencing from ≥ 1 gout flare and ≥ 2 gout flares within 12 weeks(Day 1 to Week 12)
- Mean pain Visual Analogue Scale Score (VAS) associated with gout flares(Day 1 to Week 12)
- Amount of rescue medication taken within 12 weeks(Day 1 to Week 12)
研究者
Quan Jiang
Director, Devision of Rheumatology
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
研究点 (1)
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