Comparative Trial to Investigate the Dose-Response of 4 Different Dose Levels of Minirin Melt and Placebo

What Was Tested

The trial (phase 2) is built around Desmopressin.

This is a multi-centre, randomised, placebo-controlled, double-blind, parallel-group comparative trial to be conducted in nocturia patients.

In particular, the trial is designed to link the duration of action to the clinical endpoint.

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

The registry classes the interventions as drug.

Who Took Part

Enrollment: 116 actual participants took part.

It was open to people of any sex aged from 55 years up to 75 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Given written informed consent prior to any trial-related activity is performed. Aged 55-75 years. Mean number of nocturnal voids of at least two per night. Reached post-menopause (applicable to females only).

The full record lists 4 inclusion and 24 exclusion criteria; among the exclusions: A surgical treatment for BOO or prostatic hyperplasia within the past 6 months (applicable to males only); psychosomatic or habitual polydipsia; A history or complication of urologic malignancy (e.g. bladder cancer or prostate cancer).

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.

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

As a double-blind Desmopressin study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2010-07 with completion listed for 2011-04.

It ran at 36 sites in Japan (36).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change From Baseline in Number of Nocturnal Voids After 28 Days of Treatment - Period 2 (time frame: 3 days between study days -6 to 0 (Baseline), and days 25 to 32).

It also tracked 14 secondary outcomes, for example Area Under the Urine Osmolality Curve (AUCosm), Area Under the Urine Production Curve (AUCurine Prod), Change From Baseline in Duration of First Period of Undisturbed Sleep After 28 Days of Treatment - Period 2, Change From Baseline in Total Sleep Time at Approximately Day 32, Change From Baseline in Number of Daytime Voids at Approximately Day 32 and Change From Baseline in Number of 24-hour Urine Voids at Approximately Day 32.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Desmopressin in 116 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.