Monosymptomatic Nocturnal Enuresis
Conditions
Keywords
Desmopressin, Paediatrics, urinary concentration test
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
Interventions
DRUGdesmopressin
One time dosing of desmopressin oral lyophilisate formulation. The dose is age-dependant: \>6 months and \< 2years: 60µg; ≥2 years and \<4 years: 120µg PO and ≥4 years and \<8 years: 240 µg PO. There will be blood sampling and urine sampling for PK and PD/safety
Sponsors
University Ghent
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 8 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Belgium
Outcome results
None listed