NCT02584231View on ClinicalTrials.gov

Pharmacokinetics and Pharmacodynamics of Desmopressin Oral Lyophilisate Formulation in the Paediatric Population

PHASE4CompletedINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

September 9, 2015

Primary Completion Date

March 19, 2018

Study Completion Date

February 1, 2019

Conditions
Monosymptomatic Nocturnal Enuresis
Interventions
DRUG

desmopressin

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

Trial Locations (1)

9000

Ghent University Hospital - Department of Paediatric Nephrology, Ghent

All Listed Sponsors
lead

University Ghent

OTHER

NCT02584231 - Pharmacokinetics and Pharmacodynamics of Desmopressin Oral Lyophilisate Formulation in the Paediatric Population | Biotech Hunter | Biotech Hunter