Pharmacokinetics and Pharmacodynamics of Desmopressin Oral Lyophilisate Formulation in the Paediatric Population
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Desmopressine concentrations
研究概览
简要总结
Patients suffering from nocturnal enuresis (starting from the age of 5 till adulthood) are all treated with the same dose of desmopressin, i.e. 120mcg once daily. In treatment resistant enuresis, this dose is doubled: those patients take 240mcg once daily. A pilot study performed at our department showed a correlation between weight and plasma concentration when a fixed dose of desmopressin oral lyophilisate formulation was given to the pediatric patient (older than 6 years). This study will investigate the pharmacokinetics (PK) and pharmacodynamics (PD) of desmopressin in young children, less than 8 years old. Additionally, the efficacy of desmopressin oral lyophilisate formulation in urinary concentration testing will be evaluated
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
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with an uro- and/or nephropathy who need an urinary concentration test OR Children with monosymptomatic nocturnal enuresis (based on nocturnal polyuria) with treatment failure on desmopressin tablet
- •Otherwise healthy children (on medical history and physical examination)
- •Parents or legal guardian of the child signed the informed consent form
- •Age: between 6 months and 8 years
- •Minimum weight: 8 kg
排除标准
- •Diabetes insipidus
- •Renal failure (eGFR<60ml/min/1,73m²)
- •Current urinary tract infection
- •Syndrome of inappropriate antidiuretic hormone secretion
- •Heart failure
- •Clinical significant medical conditions (renal, hepatic, gastro-intestinal, pulmonary, cardiac, endocrinologic) that might interfere with the clinical endpoints
- •Sensitivity to desmopressin or excipients of the oral lyophilisate formulation
- •Use of antibiotics, diuretics or other drugs that can influence diuresis (tricyclic antidepressants, chlorpropamide, oxcarbazepine, selective serotonin reuptake inhibitors, chlorpromazine and carbamazepine).
- •Use of drugs that influence intestinal motility (such as loperamide)
- •Anomalies of the mouth that might interfere with the intake / absorption of the medication
研究组 & 干预措施
Patients needing an urinary concentration test
Patients who need a urinary concentration test because of uro- or nephropathy (age: 6 months - 8 year)
干预措施: desmopressin (Drug)
Patients suffering from treatment resistant nocturnal enuresis
Patients suffering from treatment resistant nocturnal enuresis (age: 5 - 8 year)
干预措施: desmopressin (Drug)
结局指标
主要结局
Desmopressine concentrations
时间窗: 24 hours
The assessed pharmacokinetic parameters are desmopressine concentrations at timepoints 0, 1/4, 1/2, 1, 2, 3, 5, 6 and 7h.
次要结局
- Efficacy - urinary volume.(24 hours)
- Efficacy - osmolality in urine.(24 hours)
- Urinary concentration test(24 hours)
- Safety of desmopressin in children as assessed by registration of adverse events.(24 hours)
- Safety of desmopressin in children as assessed by the measurement of natremia.(24 hours)
研究者
Pediatrie
Prof Johan Vande Walle
University Hospital, Ghent