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

University Ghent

Status and phase

Completed

Phase 4

Conditions

Monosymptomatic Nocturnal Enuresis

Treatments

Drug: desmopressin

Study type

Interventional

Funder types

Other

Identifiers

NCT02584231

EC/2015/0616

2014-005200-13 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment

25 patients

Sex

All

Ages

6 months to 8 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Children with an uro- and/or nephropathy who need an urinary concentration test OR Children with monosymptomatic nocturnal enuresis (based on nocturnal polyuria) with treatment failure on desmopressin tablet
Otherwise healthy children (on medical history and physical examination)
Parents or legal guardian of the child signed the informed consent form
Age: between 6 months and 8 years
Minimum weight: 8 kg

Exclusion criteria

Diabetes insipidus
Renal failure (eGFR<60ml/min/1,73m²)
Current urinary tract infection
Syndrome of inappropriate antidiuretic hormone secretion
Heart failure
Clinical significant medical conditions (renal, hepatic, gastro-intestinal, pulmonary, cardiac, endocrinologic) that might interfere with the clinical endpoints
Sensitivity to desmopressin or excipients of the oral lyophilisate formulation
Use of antibiotics, diuretics or other drugs that can influence diuresis (tricyclic antidepressants, chlorpropamide, oxcarbazepine, selective serotonin reuptake inhibitors, chlorpromazine and carbamazepine).
Use of drugs that influence intestinal motility (such as loperamide)
Anomalies of the mouth that might interfere with the intake / absorption of the medication