An Extension Study Investigating the Efficacy and Safety of a Fast-Dissolving ("Melt") Formulation of Desmopressin for the Treatment of Nocturia in Adults

What Was Tested

The trial (phase 3) is built around Desmopressin.

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

The registry classes the interventions as drug.

More on the Plan

FE992026 CS31 was a multicenter open-label extension study for patients who were enrolled in Study FE992026 CS29 (NCT00477490) and had completed at least Visit 3E in Part II of that study.

The CS29 study was structured into 2 double-blind parts (Part I and Part II).

Immediately upon completion of Part I of the study, all participants on active treatment continued into Part II on the same treatment for approximately 1 to 6 months.

Participants assigned to placebo in Part I were randomly assigned to 1 of the 4 active treatments in Part II, based on re-randomization predetermined at the initial randomization (to maintain the blind).

Who Took Part

554 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.

The full record lists 2 inclusion and 1 exclusion criteria; among the exclusions: patients using loop diuretics (furosemide, torsemide, ethacrynic acid).

How the Study Was Run

Design: randomized, parallel-group and open-label.

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.

Everyone knew when Desmopressin was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2007-12 with completion listed for 2010-05.

It ran at 73 sites in United States (64) and Canada (9).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change From Baseline in Mean Number of Nocturnal Voids (time frame: Baseline of Study CS29 and Weeks 8, 12, 20, 28, 52-56, 72-76, and 92-96). Change From Baseline in Initial Period of Undisturbed Sleep (time frame: Baseline of Study CS29 and Weeks 8, 12, 20, 28, 52-56, 72-76, and 92-96).

It also tracked 10 secondary outcomes, for example Change From Baseline in Total Sleep Time, Change From Baseline in Nocturia Quality of Life (NQoL) Overall Score, Change From Baseline in NQoL Bother/Concern Domain Score, Change From Baseline in Nocturia Quality of Life (NQoL) Sleep/Energy Domain Score, Change From Baseline in the Nocturia Quality of Life (NQoL) Global Quality of Life Score and Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Global Score.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Desmopressin in 554 people.

With 554 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.