Desmopressin Melt Therapy in Patients With Nocturnal Polyuria: a Pharmacokinetic/Dynamic Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Pharmacokinetic and dynamic evaluation of desmopressin melt for treatment of nocturnal polyuria in adults
研究概览
简要总结
The objective of this study is to find out what the pharmacokinetic/dynamic (PK/PD) characteristics of desmopressin melt are in nocturia patients (compared to healthy volunteers and children). The main questions the investigators want to answer are:
- Are differences related to the pathophysiological factors involved in nocturia?
- Are there age/gender/size differences?
- Can the investigators identify patients who are likely to develop hyponatraemia?
- Can the investigators individualize treatment and reduce risk for hyponatraemia?
Day 1:
- Patient is being hospitalized in the morning
- General anamnesis and clinical examination
- Uroflow and residue measurements (3x)
- Sober blood sample, to determine plasma concentrations of Na+, Cl-, osmolality and creatinin
Day 1-2:
- In the evening at 20h:
- start (with empty bladder!) 24h miction-incontinence-residue registration: urine collections every 3 hours (every portion of urine within a period of 3 hours must be collected in the same collection device), with: registration of volumes and measurement urinary concentrations of Na+, Cl-, osmolality and creatinin
- Measurement of blood pressure during 24h
Day 2-3:
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In the evening at 19h (day 2): drink 15mL/kg water
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At 20h: take desmopressin melt 120µg + start:
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24h miction-incontinence-residue registration: registration of volumes and measurement urinary concentrations of Na+, Cl-, osmolality and creatinin (U1-U7)
-
Measurement of blood pressure during 24h
-
Collection of urine:U1 at 19h, U2 at 20h, together with intake of first desmopressin melt, U3 at 21h = 1h after desmopressin melt intake, U4 at 22h = 2 after desmopressin melt intake,U5 at 23h = 3h after desmopressin melt intake, U6 at 2h (day 3) = 6h after desmopressin melt intake, U7 at 8h = 12h after desmopressin melt intake
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Blood samples for blood levels of desmopressin: 1h, 2h, 3h, 6h after desmopressin melt intake, 12h after desmopressin melt intake + plasma concentrations of Na+, Cl-, osmolality and creatinin (safety profile)
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At 8h in the morning (day 3): drink 15mL/kg water + collection of urine per hour during 3h with measurement of urinary concentrations of Na+, Cl-, osmolality and creatinin: U8 at 9h, U9 at 10h, U10 at 11h
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Patient can go home on day 3, unless he is at high risk for side effects, high-risk patients are hospitalized for 7 days
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •written informed consent prior to the performance of any study-related activity
- •patients, men and woman, 18 years and older, with nocturnal polyuria, resulting in nocturia (2 voids or more at night) and/or nocturnal incontinence.
排除标准
- •hypersensitivity/anaphylactic reaction on desmopressin or one of the other substances
- •pregnancy
- •genitourinary tract pathology (infection, tumor,...)
- •urolithiasis
- •suspicion or evidence of cardiac failure
- •moderate to severe renal insufficiency (creatinin clearance < 50 ml/min)
- •psychogenic or habitual polydipsia
- •hyponatraemia or predisposition for hyponatraemia
- •diabetes insipidus
- •syndrome of inadequate ADH production
研究组 & 干预措施
nocturnal polyuria patient with desmopressin MELT
干预措施: Desmopressin (Drug)
结局指标
主要结局
Pharmacokinetic and dynamic evaluation of desmopressin melt for treatment of nocturnal polyuria in adults
时间窗: hospitalisation of 3 days of which 15h specific for primary outcome measurements
* blood analysis for plasma concentration of desmopressin: 1h, 2h, 3h, 6h and 12h after drug intake * urine analysis for urinary concentration of sodium, potassium, creatinin and osmolality: * after water load with 15ml/kg body weight (evening day 2): the moment of drug intake, 1h, 2h, 3h, 6h and 12h after drug intake * after water load with 15ml/kg body weight (morning day 3): 1h, 2h, 3h after water load
次要结局
- 24h miction-incontinence-residue registration: urine collections every 3 hours(2x 24h: day 1 19h - day 2 19h ; day 2 20h - day 3 20h)
- Measurement of blood pressure during 24h(2x 24h: day 1 19h - day 2 19h ; day 2 20h - day 3 20h)