Desmopressin Response in the Young

What Was Tested

This registered phase 3 trial tested Desmopressin.

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

Desmopressin.

Placebo.

The registry classes the interventions as drug.

More on the Plan

Primary nocturnal enuresis (PNE), or bedwetting, is a common childhood urological disease.

Regular tablets are more difficult to swallow for some patients and require fluid intake for swallowing.

Nasal spray absorption may be altered by seasonal allergies, upper respiratory infections or improper administration.

Who Took Part

The registry lists 132 actual participants took part.

It was open to people of any sex aged from 5 years up to 16 years.

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

Examples of who could join: Children and adolescents (age 5-16 years) with diagnosed primary monosymptomatic nocturnal enuresis. A minimum of 3 wet nights per week in the 2-week screening period without treatment.

The full record lists 2 inclusion and 3 exclusion criteria; among the exclusions: ongoing systemic antibiotic use, use of diuretics or any drugs affecting urinary concentration, or medical treatment for hyperactivity; usage of any experimental drug or device during 30 days before study entry.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

Because people in this Desmopressin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

As a double-blind Desmopressin study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2004-07 with completion listed for 2006-01.

It ran at 9 sites in Canada (9).

Its stated primary purpose is treatment.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Desmopressin in 132 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.