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

February 4, 2019 updated by: Pediatrie, University Ghent
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Ghent, Belgium, 9000
        • Ghent University Hospital - Department of Paediatric Nephrology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 8 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients needing an urinary concentration test
Patients who need a urinary concentration test because of uro- or nephropathy (age: 6 months - 8 year)
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
Other Names:
  • dDAVP
Experimental: Patients suffering from treatment resistant nocturnal enuresis
Patients suffering from treatment resistant nocturnal enuresis (age: 5 - 8 year)
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
Other Names:
  • dDAVP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 hours
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.
24 hours
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.
24 hours
Safety of desmopressin in children as assessed by registration of adverse events.
Time Frame: 24 hours
Registration of adverse events
24 hours
Safety of desmopressin in children as assessed by the measurement of natremia.
Time Frame: 24 hours
Measurement of natremia
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Ghent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 9, 2015

Primary Completion (Actual)

March 19, 2018

Study Completion (Actual)

February 1, 2019

Study Registration Dates

First Submitted

September 10, 2015

First Submitted That Met QC Criteria

October 20, 2015

First Posted (Estimate)

October 22, 2015

Study Record Updates

Last Update Posted (Actual)

February 6, 2019

Last Update Submitted That Met QC Criteria

February 4, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EC/2015/0616
  • 2014-005200-13 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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