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临床试验/EUCTR2010-022096-54-DE
EUCTR2010-022096-54-DE进行中(未招募)不适用

Randomised, prospective, double-dummy double-blinded study to evaluate safety and efficacy of Angocin Anti-Infekt N versus standard antibiotics in the treatment of acute uncomplicated cystitis - ANGOCYS

Repha GmbH0 个研究点开始时间: 2010年12月14日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • Patients of both sexes aged between 18 and 70 years, with an acute uncomplicated cystitis (diagnosed by the investigator), signed informed consent form, leucocytes in urine positive at visit 1, bacteriurie (>10^5 cfu/ml) in urine at visit 1
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 712
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 200

排除标准

  • - signs of a complicated urinary tract infection
  • - acute infection beneath cystitis
  • - known hypersensitivity to any of the components of the study medicine
  • - irritable bladder
  • - pyelonephritis, urosepsis
  • - subjects with a disease or in any situation that exposed the opinion of the investigator the subject is a significant risk of prejudice the study results or influence them significantly
  • - abnormal laboratory values

研究者

发起方
Repha GmbH

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