A 6-week Open Label Cross-over Study With 2 Different Daily Doses of Minirin® Oral Lyophilisate in Children and Adolescents With Primary Nocturnal Enuresis (PNE)

What Was Tested

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

To evaluate the preference of subjects for Minirin® oral lyophilisate treatment compared with Minirin® tablet treatment after 6 weeks.

To compare ease of use of both formulations at 3 and 6 weeks using a VAS-scale.

It had two arms (groups): 1 (active comparator) and 2 (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 221 actual participants took part.

It was open to people of any sex aged from 5 years up to 15 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Children suffering from primary nocturnal enuresis with no organic pathology. Children of either sex, not below 5 and not above 15 years of age (not below 6 years in The Netherlands and France). Children with a minimum of 6 wet nights in 2 weeks.

The full record lists 3 inclusion and 4 exclusion criteria; among the exclusions: children who have previously been treated with desmopressin or other medications for nocturnal enuresis or enuresis alarms; children receiving substances that are known or suspected to potentiate antidiuretic hormone, e.g. ssri, tricyclic antidepressant drugs, chlorpromazine and carbamazepine; diagnosed renal diabetes insipidus or central diabetes insipidus with an avp (arginine vasopressin) deficiency.

How the Study Was Run

Design: randomized, crossover and open-label.

Random assignment meant chance, not the researchers, decided who got Desmopressin and who got the comparison, which limits bias.

Each person switched between Desmopressin and the comparison at some point, usually with a gap in between.

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 2004-12 with completion listed for 2005-08.

It ran at 1 site in France.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: The primary endpoint will be the difference in the proportion of subjects who preferred each formulation at the end of the 6-week treatment period (time frame: 6 weeks (melt) and 6 weeks (tablet). Total 12 weeks).

It also tracked 6 secondary outcomes, for example Subjects will be asked to complete a QoL questionnaire at visit 2 and visit 3, Safety comparison between the 2 formulations and Comparison of compliance between the 2 formulations.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Desmopressin in 221 people.

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.