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临床试验/EUCTR2013-001838-17-GB
EUCTR2013-001838-17-GB进行中(未招募)1 期

A MULTICENTER, PROSPECTIVE, RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP PLACEBO-CONTROLLED CLINICAL STUDY FOR THE ASSESSMENT OF THE IMMUNOMODULATORY EFFICACY, SAFETY AND CLINICAL IMPACT AFTER THREE AND SIX MONTHS TREATMENT WITH A SUBLINGUAL POLYVALENT BACTERIAL VACCINE (IN ORAL MUCOSA) IN WOMEN WITH RECURRENT URINARY TRACT INFECTIONS (rUTIs). - Evaluation of the Efficacy and Safety of MV140

Syner-Med (PP) Ltd0 个研究点目标入组 240 人开始时间: 2020年8月3日最近更新:
适应症

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
240

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
Female

入选标准

  • The individuals to be included in the study will meet the following criteria:
  • ?Women who have given their informed consent. Age between 18 and 75 years.
  • ?Must be able to meet the dosage regimen
  • ?Individuals who have had at least 5 episodes of cystitis in the last 12 months.
  • ?Individuals who have not responded to hygienic-sanitary measures and / or suppressive treatment and / or postcoital prophylaxis.
  • ?Individuals who are free of urinary tract infections at the time of inclusion in the study.
  • Are the trial subjects under 18? no
  • Number of subjects for this age range: 0
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 40
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 0

排除标准

  • Non- included individuals will be those who/whose:
  • ?Have not given their informed consent.
  • ?Age is not within the established age range.
  • ?Cannot offer cooperation and/or have severe psychiatric disorders
  • ?Present a pathologic post-micturition residue.
  • ?Present moderate to severe incontinence
  • ?Present genital tumors.
  • ?Presents Urinary tract tumors.
  • ?Present lithiasis
  • ?Present alterations in the immune system
  • ?Present complicated UTIs

研究者

发起方
Syner-Med (PP) Ltd

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