Desmopressin Melt Therapy in Nocturnal Polyuria Patients: Pharmacodynamic Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Area Under Curve (AUC) frequency/volume chart during the first 14 days
研究概览
简要总结
The objective of this study is to find out what the pharmacodynamic (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?
The patient will be given a prescription to buy Minirin Melt 60µg at the local pharmacy. During 30 days, the patient has to take Minirin Melt 60µg in the evening before going to bed.
There are two groups of patients:
Group A:
Patients that still have to undergo an evaluation phase, according to standard procedures (e.g. osmolality test, blood sample). This procedure is not a part of this study. The study starts when the 1st Minirin Melt tablet has been taken (= day 1).
Group B:
This group already went through the evaluation phase (by participation to study 1 or study 3 as mentioned above) and they have been prescribed Minirin Melt 60 µg ambulatory.
The study starts when the patients takes his first prescribed Minirin Melt tablet:
- On day 3 and day 7 a blood sample will be taken at the UZ Ghent for safety control (Na+, K+, creatinin, osmolality = good clinical practice guideline). These first 2 visits (day 3 and day 7) are standard procedure. If the patient is at high risk for side effects, blood has to be taken during the first 7 days.
- On day 3 the patient has to give a urine sample.
- Patients have to fill out a frequency/volume chart during the first 14 days.
- On day 30, a 3rd blood sample will be taken
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 women, 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
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 < 60 ml/min)
- •psychogenic or habitual polydipsia
- •hyponatraemia or predisposition for hyponatraemia
- •diabetes insipidus
- •syndrome of inadequate ADH production
- •suspicion or evidence of liver failure
研究组 & 干预措施
Desmopressin Melt Therapy in Nocturnal Polyuria Patients
干预措施: Desmopressin (Drug)
结局指标
主要结局
Area Under Curve (AUC) frequency/volume chart during the first 14 days
时间窗: Every day during the first 14 days.
The decrease of number of nocturnal micturition episodes.
时间窗: At day 0
Questionnaires at day 0 to evaluate the decrease of number of nocturnal micturition episodes.
The decrease of the number of nocturnal micturition episodes.
时间窗: At day 30
Questionnaires at day 30 to evaluate the number of nocturnal micturition episodes
Registration of number of side effects at day 3.
时间窗: At day 3
Blood samples for plasma concentration of Na+, K+, creatinin, osmolality (safety profile)at day 7.
时间窗: At day 7 after first desmopressin intake
Blood samples for plasma concentration of Na+, K+, creatinin, osmolality (safety profile)at day 30.
时间窗: At day 30 after first desmopressin intake
Registration of number of side effects at day 7
时间窗: At day 7
Registration of number of side effects at day 30.
时间窗: At day 30
Blood samples for plasma concentration of Na+, K+, creatinin, osmolality (safety profile)at day 3.
时间窗: At day 3 after first desmopressin intake.
Urine sample for urine concentration of Na+, K+, creatinin and osmolality
时间窗: At day 3
次要结局
未报告次要终点