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临床试验/NCT05759767
NCT05759767进行中(未招募)不适用

The Efficacy and Safety of Medical Expulsive Therapy After Extracorporeal Shock Wave Lithotripsy (ESWL) in Pediatric Urolithiasis

Mansoura University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2021年2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
状态
进行中(未招募)
入组人数
120
试验地点
1
主要终点
assess the Stone-free rate (SFR) between groups

研究概览

简要总结

The aim of this study is to evaluate the clinical efficacy and safety of MET after ESWL in pediatric urolithiasis.

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
Double (Participant, Investigator)

入排标准

年龄范围
5 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Radio- opaque renal stone ≤ 2 cm or ≤ 1cm lower calyceal stone
  • Normal kidney function.

排除标准

  • Bleeding diatheses
  • Uncontrolled UTIs
  • Severe skeletal malformations

研究组 & 干预措施

Tamsulosin

Active Comparator

Children in this group will receive medical expulsive therapy in the form of (tamsulosin at a dose of 0.01 mg/kg once daily for 3 weeks after ESWL session.

干预措施: Tamsulosin (Drug)

Placebo

Placebo Comparator

Children in this group will receive Placebo for 3 weeks after ESWL session.

干预措施: Placebo (Drug)

结局指标

主要结局

assess the Stone-free rate (SFR) between groups

时间窗: three months

SFR is defined as complete stone removal without visible stone fragments on radiological studies assessed by Low dose Non Contrast Computed Tomography

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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