Influence of Food-intake on Desmopressin Oral Tablets and MELT-formulation

What Was Tested

The trial (phase 4) is built around Desmopressin.

Alarm-treatment as well as Desmopressin, a synthetic analogue of human vasopressin, are considered the only evidence-based medicine (EBM) IA treatments in monosymptomatic nocturnal enuresis (MNE).

It had two arms (groups): desmopressin tablet (active comparator) and desmopressin MELT-formulation (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 24 actual participants took part.

It was open to people of any sex aged from 6 years up to 16 years.

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

Examples of who could join: Children aged 6-16 years old. With MNE and nocturnal polyuria. Treated with desmopressin tablet, non or partial responders, for whom change to MELT formulation is indicated according to the international standard guidelines.

The full record lists 3 inclusion and 3 exclusion criteria; among the exclusions: no systemic use of antibiotics, diuretics, other medication that influences urinary concentrating mechanism; abnormalities of oral mucosa which could influence drugrelease or absorption.

How the Study Was Run

Design: non-randomized, crossover and open-label.

In the crossover set-up each of the participants took both Desmopressin and the comparison in turn, acting as their own control.

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.

It started in 2009-12 with completion listed for 2010-04.

It ran at 1 site in Belgium.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Bioavailability of desmopressine MELT and tablet when taken with meal (time frame: at 1h, 2h and 6h post adminstration).

What This Means in Plain Language

Put simply, this is a phase 4, non-randomized trial of Desmopressin in 24 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.