therapeutic population: monosympthomatic enuresis nocturna diagnostic population: children with a history of a urinary tract infection or suspicion of renal damage who need a renal concentration test
Conditions
Interventions
Trade Name: Minirin Melt 60 microgram lyophilisaat voor oraal gebruik
Pharmaceutical Form: Sublingual tablet
INN or Proposed INN: DESMOPRESSIN
CAS Number: 16679-58-6
Concentration unit: µg microgram(
Sponsors
Ghent University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -children with uro-nephropathy who need a renal concentration test, or children with monosympthomatic enuresis nocturna and nightly polyuria with lack of efficacy of desmopressin tablet -healthy children (cfr medical history and clinical examination) -informed consent voluntary signed by the parents or legal guardian -age between 6 months and 8 years -minimum weight of 8 kg Are the trial subjects under 18? yes Number of subjects for this age range: 24 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -diabetes insipidus (proven central diabetes insipidus) -renal insufficiency (eGFR < 60ml/min/1,73m²) -active urine tract infection (on day of testing, based on clinical data) - SIADH (syndrome of inappropriate ADH-release), -heart failure -clinical significant disease (renal, hepatic, gastrointestinal, pulmonary, cardia, endocrinological or neurological) which could interfere with the evaluation of the end points -hypersensitivity of desmopressin and/or the excipients of the lyophilisate (lactose monohydrate, potato starch, povidone, magnesium stearate) -the use of antibiotics, diuretics or other medicines (like tricyclic antidepressants, chlorpropamide, oxcarbazepine, selective serotonin reuptake inhibitors, chlorpromazin and carbamazepine) which could influence the diuresis -use of medication (like loperamide) which could influence the gastrointestinal motility -abnormalities or diseases of the oral cavity which vould influence the release or absorption of the medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to evaluate the influence of the weight, length and gender on the pharmacokinetcs of desmopressin;Secondary Objective: to evaluate the pharmacodynamics of desmopressin on children with enuresis nocturna: -changes in urinary osmolality -anti-diuretic effect -duration of activity to evaluate the oral lyophilisate as route of administration for the renal concentration test to evaluate the safety of despmopressin -adverse events -vital parameters (blood pressure, heart rate) -natremia -weight;Primary end point(s): to evaluate the influence of the weight, length and gender on the pharmacokinetcs of desmopressin;Timepoint(s) of evaluation of this end point: after last visit last subject | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): to evaluate the pharmacodynamics of desmopressin on children with enuresis nocturna: -changes in urinary osmolality -anti-diuretic effect -duration of activity to evaluate the oral lyophilisate as route of administration for the renal concentration test to evaluate the safety of despmopressin -adverse events -vital parameters (blood pressure, heart rate) -natremia -weight;Timepoint(s) of evaluation of this end point: after last visit last subject | — |
Countries
Belgium
Contacts
Public ContactBimetra Clinics
Ghent University Hospital
Outcome results
None listed