A Trial to Investigate Efficacy, Safety and Tolerability of FE 201836 for Nocturia Due to Nocturnal Polyuria in Adults

What Was Tested

In this phase 2 trial, researchers set out to test Desmopressin.

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

The registry classes the interventions as drug.

Who Took Part

Enrollment: 302 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: Adults ≥18 years of age (at the time of written consent). Medical history of, or subject reported nocturia symptoms during the 6 months prior to Visit 1. ≥2 nocturnal voids (an average over 3 days) as documented in the 3-day e-Diary prior to Visit 2.

The full record lists 6 inclusion and 27 exclusion criteria; among the exclusions: current diagnosis of obstructive sleep apnoea (osa); restless legs syndrome (rls); history of any neurological disease affecting bladder function or muscle strength (e.g., multiple sclerosis, parkinson's, spinal cord injury, spina bifida).

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

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

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 2017-07-27 with completion listed for 2019-10-31.

It ran at 72 sites in United States (43), Canada (10), Belgium (5), Czechia (5), Hungary (5) and Germany (3).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change From Baseline in Aggregated Mean Number of Nocturnal Voids During 12 Weeks of Treatment (time frame: Baseline, during 12 weeks of treatment).

It also tracked 45 secondary outcomes, for example Change From Baseline in Mean Number of Nocturnal Voids at Week 1, Change From Baseline in Mean Number of Nocturnal Voids at Week 4, Change From Baseline in Mean Number of Nocturnal Voids at Week 8, Change From Baseline in Mean Number of Nocturnal Voids at Week 12, Responder Rate in Nocturnal Voids at Week 1 and Responder Rate in Nocturnal Voids at Week 4.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Desmopressin in 302 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.