Desmopressin melt therapy in nocturnal polyuria patients: pharmacodynamic study

Ghent University Hospital0 个研究点目标入组 5 人2011年9月14日

概览

暂无简介。

注册库

who.int

开始日期

2011年9月14日

结束日期

2013年2月1日

最后更新

4年前

研究类型

Interventional clinical trial of medicinal product

性别

All

发起方

•\- 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

•\- 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