Efficacy and Safety of Desmopressin Melt for the Treatment of Nocturia

What Was Tested

This registered phase 3 trial tested Desmopressin.

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

Participants took a placebo 'melt' for 28 days to complete part 1 of the study. In part 2, placebo patients were randomized to one of the other 4 treatment arms based on assignments predetermined at the initial randomization, to receive active desmopressin melt for between 1 and 6 months (until the database for part 1 was locked and treatment was unblinded).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 799 actual participants took part.

It was open to people of any sex 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 the performance of any study-related activity. Patients 18 years and older with an average of ≥ 2 nocturnal voids per night as determined by a 3 day frequency-volume chart during the screening period.

The full record lists 2 inclusion and 34 exclusion criteria; among the exclusions: surgical treatment for bladder outlet obstruction/benign prostatic hyperplasia performed within the past 6 months; pregnancy. females of reproductive age must have documentation of a reliable method of contraception; use of pessary for pelvic prolapse.

How the Study Was Run

The set-up was randomized, parallel-group and triple-blind.

The participants were allocated by chance, so the Desmopressin group and the comparison group should start out alike.

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

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

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

It started in 2007-05 with completion listed for 2008-02.

It ran at 80 sites in United States (70) and Canada (10).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Part I: Change From Baseline in Mean Number of Nocturnal Voids at Week 4 (time frame: - Week 3 to Day 1 (Baseline), Week 4 (end of Part I)).

It also tracked 10 secondary outcomes, for example Part II: Change From Baseline in Mean Number of Nocturnal Voids to Days 29, 57, 113 and 169, Part I: Change From Baseline in Total Reported Sleep Time at Week 4, Part I: Change From Baseline in Initial Period of Undisturbed Sleep at Week 4, Part I: Change From Baseline in the Two Domain Scores of the Nocturia Quality of Life (NQoL) Questionnaire at Week 4, Part I: Change From Baseline in Quality of Sleep as Assessed by the Global Score of the Pittsburgh Sleep Quality Index (PSQI) at Week 4 and Part I: Participants With Treatment-Emergent Adverse Events (AEs) During Study Part I.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Desmopressin in 799 people.

With 799 participants it is a large trial for this field.

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.