Trial Investigating the Long Term Safety and Tolerability of Desmopressin Orally Disintegrating Tablets (ODT) for Nocturia Due to Nocturnal Polyuria in Japanese Subjects

What Was Tested

In this phase 3 trial, researchers set out to test Desmopressin.

It had eight arms (groups): one (experimental), one (experimental), one (experimental), one (experimental) and one (experimental).

Subjects received placebo in trial 000129.

New female subjects.

The registry classes the interventions as drug.

Who Took Part

The registry lists 503 actual participants took part.

It was open to people of any sex aged from 20 years with no upper age limit.

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

Examples of who could join: Written informed consent prior to performance of any trial-related activity for the 000131 trial. Has completed participation in trial 000129 or 000130.

The full record lists 2 inclusion and 40 exclusion criteria; among the exclusions: withdrawal from clinical trial 000129 or 000130; written informed consent prior to performance of any trial-related activity; adult ≥20 years of age.

How the Study Was Run

The set-up was randomized, parallel-group and double-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 and investigator.

It started in 2017-01-11 with completion listed for 2018-09-11.

It ran at 1 site in Japan.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: The frequency and severity of adverse events (time frame: Up to 1 year). The incidence and severity of hyponatraemia (time frame: Up to 1 year).

It also tracked 7 secondary outcomes, for example Change from baseline in mean number of nocturnal voids, Change from baseline in mean time to first awakening to void, Change from baseline in mean nocturnal urin volume, Change from baseline in mean Nocturnal Polyuria Index (NPI), Change from baseline in Nocturia-Specific Quality-of-Life Questionnaire (N-QoL) and Change from baseline in Insomnia Severity Index (ISI).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Desmopressin in 503 people.

With 503 participants it is a large trial for this field.

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.