KCT0006930招募中未知
Pragmatic clinical trial of initiating urate lowering therapy during acute gout attack
Seoul Metropolitan Government Seoul National University Boramae Medical Center0 个研究点目标入组 305 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 305
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1) Korean adult men and women aged 19 or older
- •2) At screening, patients diagnosed with acute gout according to 1977 American College of Rheumatology classification criteria for acute gout
- •3) Patients who need to start urate lowering therapy. The indications for urate lowering therapy as follows.
- •? have one or more tophis
- •? have acute gout flare more than once a year
- •? Gout arthritis on X-rays of the hands or feet
- •? when the physicians determines that urate lowering therapy is necessary
- •4) Patients who provided written informed consent for the clinical trial
排除标准
- •1) Patients with ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease, severe congestive heart failure patients and congestive heart failure patients (NYHA II~IV), uncontrolled hypertensive patients (SBP 180 mmHg or DBP 110 mmHg and above)
- •2) Patients with a history of gastrointestinal bleeding or perforation related to previous NSAID therapy, active peptic ulceration or bleeding
- •3) Patients with a history of cerebral hemorrhage or systemic bleeding, or with coagulation disorders or severe hematologic disorders
- •4) Individuals with genetic issues such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
- •5) Patients with inflammatory bowel diseases such as Crohn's disease or ulcerative colitis
- •6) Patients with a history of hypersensitivity reactions or clinically significant hypersensitivity reactions to urate-lowering therapies, such as colchicine, which are investigational drugs
- •7) Patients with a history of hypersensitivity reactions, asthma, rhinitis, nasal polyps, urticaria, allergic reactions to aspirin or other NSAIDs, or a history thereof
- •8) Pregnant or breastfeeding women, defined as women from the time of conception to the end of pregnancy, with a positive urine pregnancy test result. Also, those who do not consent to the use of appropriate contraceptive methods during the clinical trial period
- •9) For fertile women, those who do not agree to adhere to medically acceptable contraceptive methods for a minimum of 7 days during the clinical trial period and after the end of the trial
- •10) A patient who has received corticosteroids or urate-lowering medications (allopurinol, febuxostat, benzbromarone) within 4 weeks prior to screening
- •11) Individuals who have received or plan to receive mercaptopurine or azathioprine within 1 week or a period longer than 5 times the half-life from the screening
- •12) Patients with severe renal impairment (eGFR <50mL/min/1.73 m2)
- •13) Patients with severe hepatic impairment (AST, ALT, or total bilirubin levels greater than 3 times the upper limit of normal)
- •14) Patients who have participated in other clinical trial and have been exposed to investigational drugs or investigational medical devices within 4 weeks prior to screening
- •15) Individuals with a history of alcohol addiction or substance abuse within the past 5 years from the screening date
- •16) Individuals with clinically significant diseases, as determined by the investigator, that would warrant exclusion from this study
研究者
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