Pharmacokinetics and Pharmacodynamics of Desmopressin Oral Lyophilisate Formulation in the Paediatric Population
- Registration Number
- NCT02584231
- Lead Sponsor
- University Ghent
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Patients suffering from treatment resistant nocturnal enuresis desmopressin Patients suffering from treatment resistant nocturnal enuresis (age: 5 - 8 year) Patients needing an urinary concentration test desmopressin Patients who need a urinary concentration test because of uro- or nephropathy (age: 6 months - 8 year)
- Primary Outcome Measures
Name Time Method Desmopressine concentrations 24 hours The assessed pharmacokinetic parameters are desmopressine concentrations at timepoints 0, 1/4, 1/2, 1, 2, 3, 5, 6 and 7h.
- Secondary Outcome Measures
Name Time Method Efficacy - urinary volume. 24 hours PD of desmopressin in children with nocturnal enuresis that is resistant to treatment with desmopressin tablet. First PD parameter is antidiuretic effect. This is urinary volume per hour.
Efficacy - osmolality in urine. 24 hours PD of desmopressin in children with nocturnal enuresis that is resistant to treatment with desmopressin tablet. Second PD parameter is urinary concentration capacity. This is osmolality in urine.
Urinary concentration test 24 hours Evaluation of the oral lyophilisate formulation of desmopressin for the urinary concentration test. Assessed parameter is urinary concentration capacity.
Safety of desmopressin in children as assessed by registration of adverse events. 24 hours Registration of adverse events
Safety of desmopressin in children as assessed by the measurement of natremia. 24 hours Measurement of natremia
Trial Locations
- Locations (1)
Ghent University Hospital - Department of Paediatric Nephrology
🇧🇪Ghent, Belgium