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
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
25
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
Ghent University Hospital - Department of Paediatric Nephrology
Ghent, Belgium
Desmopressine concentrations
The assessed pharmacokinetic parameters are desmopressine concentrations at timepoints 0, 1/4, 1/2, 1, 2, 3, 5, 6 and 7h.
Time frame: 24 hours
Efficacy - urinary volume.
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.
Time frame: 24 hours
Efficacy - osmolality in urine.
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.
Time frame: 24 hours
Urinary concentration test
Evaluation of the oral lyophilisate formulation of desmopressin for the urinary concentration test. Assessed parameter is urinary concentration capacity.
Time frame: 24 hours
Safety of desmopressin in children as assessed by registration of adverse events.
Registration of adverse events
Time frame: 24 hours
Safety of desmopressin in children as assessed by the measurement of natremia.
Measurement of natremia
Time frame: 24 hours
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