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Trial · Interventional

CompletedPhase 4Registry data

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

NCTNCT02584231 (opens ClinicalTrials.gov in a new tab)Other idEC/2015/0616Other id2014-005200-13Other id2014
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Overview

Status
Completed
Phase
Phase 4
Enrollment
25 participants (actual)
Sponsor
University Ghent · Other
Design
Not randomized · Open label (no masking)
Countries
1 country

Belgium

Start
9 Sept 2015
Primary completion
19 Mar 2018
Completion
1 Feb 2019
First posted
22 Oct 2015 (estimated)
Last update posted
6 Feb 2019
Conditions
Monosymptomatic Nocturnal Enuresis

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201520162017201820192020
  1. Ph 4

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

    NCT02584231

    9 Sept 2015 to 1 Feb 2019

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

  • desmopressinDrug

Arms2

  • Experimental

    Patients needing an urinary concentration test

    Patients who need a urinary concentration test because of uro- or nephropathy (age: 6 months - 8 year)

  • Experimental

    Patients suffering from treatment resistant nocturnal enuresis

    Patients suffering from treatment resistant nocturnal enuresis (age: 5 - 8 year)

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Desmopressine concentrations

    Time frame · 24 hours

    Registry description

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

Secondary outcomes(5)

  1. Efficacy - urinary volume.

    Time frame · 24 hours

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    Registration of adverse events

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

    Time frame · 24 hours

    Registry description

    Measurement of natremia

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

More studies

1 study on this page

Indexing hint: Randomized controlled trial · 2020

An Integrated Paediatric Population PK/PD Analysis of dDAVP: How do PK Differences Translate to Clinical Outcomes?

Michelet et al. 2020Clinical pharmacokineticscited by 5

PMID 31347012DOI 10.1007/s40262-019-00798-6PUB-31347012

Full text at the publisher
Publisher page

Eligibility

Who could join, as posted.

Sex
All
Age
from 6 Months up to 8 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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