NCT02011737Unknown4 期
The Effectiveness and Safety of Naftopidil 75mg for Improving Clearance of Ureteral and Renal Stones After Shockwave Lithotripsy: Prospective Randomized Controlled Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Difference of the treatment success rate in two weeks after ESWL between treatment group and placebo group
研究概览
简要总结
The purpose of this study is to evaluate Efficacy and Safety of oral intake of Naftopidil 75mg once daily for the improving clearance of ureteral or renal stones.
详细描述
Prospective, Single-center, Double blind, Randomized controlled trial
Treatment
- Oral Naftopidil 75 mg once daily are given to the patients who are scheduled for shockwave lithotripsy (ESWL) because of ureteral or renal stones.
Follow up Assessments including X-ray(KUB), visual analogue pain scale, are done 2, 4, and 6 weeks after the ESWL.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Radio-opaque (identifiable in KUB) ureter or kidney calculi
- •size criteria is from 5mm to 15mm
排除标准
- •Symptomatic acute urinary tract infection during the run-in period
- •severe hydronephrosis
- •2 or more urinary stones
- •Radiolucent (non-visible in KUB) stone
- •recent intervention for the urinary stone within 6 month
- •Patients who have ureteral stent
- •over 2.0 mg/dl of serum creatinine level
- •severe hepatic dysfunction
- •orthostatic hypotension
- •current usage of alpha-adrenergic blocker or calcium channel blocker
- •Pregnant or nursing women
- •Age under 15 year
- •severe or uncontrolled medical conditions
研究组 & 干预措施
Naftopidil
Active Comparator
Naftopidil 75mg once daily
干预措施: naftopidil 75mg (Drug)
结局指标
主要结局
Difference of the treatment success rate in two weeks after ESWL between treatment group and placebo group
时间窗: 2 weeks after ESWL
Treatment success is defined as no or less than 3 mm size remnant stone
次要结局
- Difference of the treatment success rate after ESWL between treatment group and placebo group(4, 6 weeks after ESWL)
- Adverse Event(2,4,6weeks)
- pain scale(baseline, 2, 4, 6 weeks)
- rate of additional intervention(6 week)
研究者
HAN, DEOK HYUN
Assistant Professor
Samsung Medical Center
研究点 (1)
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