Study With Two Different Doses of Desmopressin Orally Lyophilisate Tablet With Nocturnal Enuresis

What Was Tested

This registered phase 3 trial tested Desmopressin.

It had two arms (groups): Desmopressin (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 89 actual participants took part.

It was open to people of any sex aged from 6 years up to 15 years.

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

Examples of who could join: Age 6 or above but under 16 regardless of gender. Had 10 or more wet nights during the 14-day baseline period and at least 4 wet nights in each respective week. Deemed healthy by the investigator. Able to agree to and comply with fluid-intake restriction during the clinical trial and matters specified in the clinical trial protocol. Consent from the pediatric patient's legally acceptable representative.

The full record lists 10 inclusion and 9 exclusion criteria; among the exclusions: suffer from enuresis with an underlying disease; participated in another clinical trial within six months preceding consent; used an intranasal desmopressin in the past.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

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 and investigator.

It started in 2010-01 with completion listed for 2010-09.

It ran at 15 sites in Japan (15).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in the Number of Wet Nights Between Baseline and Treatment Period II.

It also tracked 2 secondary outcomes, for example Change in Number of Wet Nights Between Baseline and Treatment Period I and Change in Number of Wet Nights Between Treatment Periods I and II.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Desmopressin in 89 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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