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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02584231
• Other study ID #: EC/2015/0616
• Secondary ID: 2014-005200-13
• Status: Completed
• Phase: Phase 4
• Start date: September 9, 2015
• Est. completion date: February 1, 2019

Study information

• Verified date: February 2019
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: February 1, 2019
• Est. primary completion date: March 19, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 8 Years

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Monosymptomatic Nocturnal Enuresis
• Nocturnal Enuresis

Intervention

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

Locations

Country	Name	City	State
Belgium	Ghent University Hospital - Department of Paediatric Nephrology	Ghent

Sponsors (1)

Lead Sponsor	Collaborator
University Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Desmopressine concentrations	The assessed pharmacokinetic parameters are desmopressine concentrations at timepoints 0, 1/4, 1/2, 1, 2, 3, 5, 6 and 7h.	24 hours
Secondary	Efficacy - urinary volume.	PD of desmopressin in children with nocturnal enuresis that is resistant to treatment with desmopressin tablet. First PD parameter is antidiuretic effect. This is urinary volume per hour.	24 hours
Secondary	Efficacy - osmolality in urine.	PD of desmopressin in children with nocturnal enuresis that is resistant to treatment with desmopressin tablet. Second PD parameter is urinary concentration capacity. This is osmolality in urine.	24 hours
Secondary	Urinary concentration test	Evaluation of the oral lyophilisate formulation of desmopressin for the urinary concentration test. Assessed parameter is urinary concentration capacity.	24 hours
Secondary	Safety of desmopressin in children as assessed by registration of adverse events.	Registration of adverse events	24 hours
Secondary	Safety of desmopressin in children as assessed by the measurement of natremia.	Measurement of natremia	24 hours