JPRN-jRCT2031190051进行中（未招募）2 期
A Double-Blind, Placebo-Controlled, Randomized, Multicenter Study of the Expulsion-Promoting Effect of Tadalafil on Ureteral Stones
Arai Seiji0 个研究点目标入组 50 人开始时间: 2019年7月3日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •(1)Patients diagnosed with ureteral calculus
- •(2)Patients whose ureteral calculus can be confirmed with KUB
- •(3)Single unilateral ureteral calculus of 3 mm or more and less than 10 mm (size of calculus is evaluated by CT)
- •(4)Patients within 5 days from the onset of ureteral calculi (the day of outpatient visit with colic attack or hematuria)
- •(5)Patients over 20 years old
- •(6)Patients whose written consent for participation in this trial can be obtained
排除标准
- •(1)Patients receiving the following drugs
- •1)PDE5 inhibitor
- •2)alpha1 blocker
- •3)Calcium antagonist
- •4)Steroid agent (except external preparation)
- •5)Nitric acid agent or nitrogen monoxide (NO) donor (nitroglycerin, amyl nitrite, isosorbide nitrate etc.)
- •6)Soluble guanylate cyclase (sGC) stimulator (Rio sigato)
- •7)Drugs that strongly inhibit CYP3A4
- •(2)Patients with cardiovascular disorders listed below
- •Unstable angina
- •Heart failure (NYHA classification III or higher)
- •Uncontrolled arrhythmia, hypotension (blood pressure <90/50 mmHg) or hypertension (Resting blood pressure> 170/100 mmHg)
- •The history of myocardial infarction within 3 months before investigational drug administration
- •The past history of cerebral infarction, cerebral hemorrhage within 6 months before investigational drug administration
- •(3)Patients with moderate renal injury (below)
- •Serum creatinine level: 1.5 x ULN mg / dl or more
- •(4)Patients with severe liver disorder (below)
- •Blood bilirubin level: 3.0 x ULN mg / dl or more
- •Aspartate transferase (AST) value: 5.0 x ULN U / L or more
- •Alanine aminotransferase (ALT) value: 5.0 x ULN U / L or more
- •(5)Patients with concomitant urinary tract infections (fever and positive urinary white blood cells)
- •(6)Patients who need drinking restriction
- •(7)Patients who are pregnant and may be pregnant, or patients who are nursing
- •(8)Patients who can not come to the hospital for evaluation of treatment effect
- •(9)In addition, patients judged to be inappropriate by the investigator or subinvestigator
研究者
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