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临床试验/NCT00489112
NCT00489112Unknown4 期

The Use of Medical-Expulsive Therapy With Alfuzocine xl 10mg x1/d for Distal Ureterolithiasis.a Randomized Prospective Study

HaEmek Medical Center, Israel4 个研究点 分布在 1 个国家开始时间: 2007年6月21日最近更新:
适应症
相关药物

试验速览

阶段
4 期
试验地点
4

研究概览

简要总结

We will performe a prospective randomized study to evaluate the effects of the addition of alfuzocine xl 10 mg once a day for the conservative treatment of selected ureteral stones. A total of 60 patients with distal ureteral calculi will randomly divide into two treatment groups: group A (n=30) who will receive only analgetic therapy(Dipyrone)and diclofenac i.m. 75mg and group B (n=30) who will receive the same therapy plus alfuzocin xl (10 mg/daily) for a maximum of 2 weeks.No significant differences will be between the groups for age, gender distribution and mean stone size measured in the single largest dimension at presentation.Randomization will be done only with the patients permission after they had read a summary describing the goals of conservative management and a description of the drugs they would be taking. Potential side effects and complications of the drugs were discussed. The expulsion rate will the primary end-point of this study.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Stone in the distal ureter until 1 cm of diameter

排除标准

  • Evidence of urinary tract infection or sepsis
  • Moderate or severe hydronephrosis
  • Acute renal failure
  • Ureteral stricture
  • Stone with >1cm of diameter
  • Previuos use of alpha blocker
  • Pregnancy
  • Previuos ureteral endoscopic or open surgery

研究者

申办方类型
Other

研究点 (4)

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