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

Monosymptomatic Nocturnal Enuresis Clinical Trial

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

Status Completed

Clinical Trial 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

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Enuresis
• Monosymptomatic Nocturnal Enuresis
• Nocturnal Enuresis

• NCT number: NCT02584231
• Study type: Interventional
• Source: University Hospital, Ghent
• Status: Completed
• Phase: Phase 4
• Start date: September 9, 2015
• Completion date: February 1, 2019