跳至主要内容
临床试验/EUCTR2011-004560-29-BE
EUCTR2011-004560-29-BE进行中(未招募)1 期

Desmopressin melt therapy in nocturnal polyuria patients: pharmacodynamic study

Ghent University Hospital0 个研究点目标入组 5 人开始时间: 2011年9月14日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
5

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

  • - Written informed consent prior to the performance of any study-related activity
  • - Patients 18 years and older with an average of = 2 nocturnal voids per night
  • - Evidence for nocturnal polyuria (nocturnal urine volume >33% of total volume over 24h), determined on frequency/volume chart
  • - Diuresis < 2,5L
  • 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 40
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 10

排除标准

  • - hypersensitivity/anaphylactic reaction on desmopressin or one of the other substances
  • - pregnancy
  • - genito-urinary tract pathology (infection, tumor,...)
  • - urolithiasis
  • - suspicion or evidence of cardiac failure
  • - suspicion or evidence of liver failure
  • - moderate to severe renal insufficiency (creatinin clearance < 60 ml/min)
  • - psychogenic or habitual polydipsia
  • - hyponatriemia or predisposition for hyponatriemia (sodium < 135 mmol/L) before inclusion
  • - diabetes insipidus
  • - syndrome of inadequate ADH production

研究者

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