study of the pharmacokinetics and pharmacodynamics of desmopressin oral lyophilisate - route of administration in the pediatric patient population - SAFEPEDRUG

Ghent University0 sites24 target enrollmentJune 11, 2015

Overview

No summary available.

Registry

who.int

Start Date

June 11, 2015

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•\-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

•\-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