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

What Was Tested

In this phase 4 trial, researchers set out to test Desmopressin.

It had two arms (groups): Patients needing an urinary concentration test (experimental) and Patients suffering from treatment resistant nocturnal enuresis (experimental).

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

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

The registry classes the interventions as drug.

Who Took Part

25 actual participants took part.

It was open to people of any sex aged from 6 months up to 8 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 5 inclusion and 10 exclusion criteria; among the exclusions: diabetes insipidus; current urinary tract infection; syndrome of inappropriate antidiuretic hormone secretion.

How the Study Was Run

The set-up was non-randomized, single-group and open-label.

Everyone knew when Desmopressin was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2015-09-09 with completion listed for 2018-03-19.

It ran at 1 site in Belgium.

Its stated primary purpose is diagnostic.

What Was Measured

Primary outcome: Desmopressine concentrations (time frame: 24 hours).

It also tracked 5 secondary outcomes, for example Urinary concentration test, Safety of desmopressin in children as assessed by registration of adverse events and Safety of desmopressin in children as assessed by the measurement of natremia.

What This Means in Plain Language

Put simply, this is a phase 4, non-randomized trial of Desmopressin in 25 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Desmopressin compound page, all human trials.