Investigation of the Superiority Effect of Orally Disintegrating Desmopressin Tablets to Placebo in Terms of Night Voids Reduction in Nocturia Adult Male Patients

What Was Tested

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

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

The registry classes the interventions as drug.

Who Took Part

395 actual participants took part.

It was open to men only aged from 18 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. Male sex 18 years of age or older. At least 2 voids every night in a consecutive 3-day period during the screening period based on the patient diary.

The full record lists 3 inclusion and 25 exclusion criteria; among the exclusions: interstitial cystitis; chronic prostatitis/chronic pelvic pain syndrome; surgical treatment, including transurethral resection, for boo or benign prostatic hyperplasia within the past 6 months.

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.

The Desmopressin group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received Desmopressin.

Those kept unaware of assignments: participant and investigator.

It started in 2011-02 with completion listed for 2012-01.

It ran at 56 sites in United States (51) and Canada (5).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change From Baseline in Mean Number of Nocturnal Voids Averaged Over a 3-Month Period (time frame: Day 1 (Baseline), Week 1, Months 1, 2, 3 (3-month double-blind treatment period)).

It also tracked 9 secondary outcomes, for example Change From Baseline in Mean Number of Nocturnal Voids at Month 3, Change From Baseline in Mean Time to First Nocturnal Void at Month 3, Change From Baseline in Nocturnal Urine Volume at Month 3, Change From Baseline in 24-Hour Urine Volume at Month 3, Summary of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Double-Blind Period and Summary of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Open-Label Period.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Desmopressin in 395 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.