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Completed

NCT Number: NCT02584231

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

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

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Key information

Conditions

Monosymptomatic Nocturnal Enuresis

Age range

6 month–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ghent University Hospital - Department of Paediatric Nephrology

Ghent, 9000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Desmopressin

Drug

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

Other names: dDAVP

Primary outcomes

  1. 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

  1. 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.

  2. 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.

  3. 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.

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

    Time frame: 24 hours

    Registration of adverse events

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

    Time frame: 24 hours

    Measurement of natremia

Sponsors and collaborators

Lead sponsor

University Ghent

Other

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2019
First posted
Oct 22, 2015
Registry last updated
Feb 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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