EUCTR2011-004560-29-BE进行中(未招募)1 期
Desmopressin melt therapy in nocturnal polyuria patients: pharmacodynamic study
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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