Trial of Desmopressin Orally Disintegrating Tablets (ODT) for Nocturia Due to Nocturnal Polyuria in Japanese Male Subjects

What Was Tested

The trial (phase 3) is built around Desmopressin.

It had three arms (groups): one (experimental), one (experimental) and Placebo (placebo comparator).

Desmopressin ODT.

Desmopressin ODT.

Placebo ODT.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 342 actual participants took part.

It was open to men only 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. Man ≥20 years of age. Nocturia symptoms present for ≥6 months prior to trial entry at Visit 1. ≥2 nocturnal voids at the end of screening period prior to Visit 2. Nocturnal polyuria at the end of screening period prior to Visit 2.

The full record lists 7 inclusion and 31 exclusion criteria; among the exclusions: history or diagnosis of any of the following urological diseases at visit 1:; interstitial cystitis or bladder pain disorder; suspicion of moderate or severe benign prostate hyperplasia (bph), defined as international prostate symptom score (ipss) ≥8 points and:.

How the Study Was Run

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

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

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

Neither the participants nor the staff measuring them knew who was on Desmopressin, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2016-09 with completion listed for 2017-09-29.

It ran at 1 site in Japan.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change from baseline in mean number of nocturnal voids during 12 weeks of treatment (time frame: Week 1, 4, 8 and 12).

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

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Desmopressin in 342 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.