Current partner codePEPTIDESDE
NCT02584231·Phase 4·INTERVENTIONAL

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

Status

Completed

Phase

Phase 4

Enrollment

25

Locations

1

Results

Not posted

Publications

1

Study summary

What the protocol is testing.

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

Interventions

Treatment arms and agents.

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

Timeline

From registration to results.

  1. First posted

    Oct 22, 2015

  2. Study start

    Sep 9, 2015

  3. Primary completion

    Mar 19, 2018

  4. Study completion

    Feb 1, 2019

  5. Results posted

    Not reported

  6. Registry updated

    Feb 6, 2019

Outcomes

What the study measures.

Primary outcomes

Desmopressine concentrations

Time frame · 24 hours

The assessed pharmacokinetic parameters are desmopressine concentrations at timepoints 0, 1/4, 1/2, 1, 2, 3, 5, 6 and 7h.

Secondary outcomes

Efficacy - urinary volume.

Time frame · 24 hours

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.

Efficacy - osmolality in urine.

Time frame · 24 hours

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.

Urinary concentration test

Time frame · 24 hours

Evaluation of the oral lyophilisate formulation of desmopressin for the urinary concentration test. Assessed parameter is urinary concentration capacity.

Safety of desmopressin in children as assessed by registration of adverse events.

Time frame · 24 hours

Registration of adverse events

Safety of desmopressin in children as assessed by the measurement of natremia.

Time frame · 24 hours

Measurement of natremia

Eligibility

Who can take part.

Minimum age
6 Months
Maximum age
8 Years
Sex
ALL
Healthy volunteers
No

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

Study locations

1 registered sites.

Belgium. Showing up to 24 locations stored in the fast local snapshot.

Ghent University Hospital - Department of Paediatric Nephrology

Ghent, Belgium

Related trials

More studies on Desmopressin.

Related PeptideStat pages

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