A Study of Minirin Melt in Japanese Patients With Central Diabetes Insipidus (CDI).

What Was Tested

The trial (phase 3) is built around Desmopressin.

It had 1 arm (groups): Desmopressin (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 20 actual participants took part.

It was open to people of any sex aged from 6 years up to 75 years.

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

Examples of who could join: Participants must be documented to have Central Diabetes Insipidus (CDI) by at least two of the following four criteria (a-d):. Complete and continuous control of the DI by desmopressin therapy without "breakthrough" diuresis, hypernatremia, hyponatremia, or symptoms or signs of water intoxication. A deficient plasma vasopressin response to osmotic or non-osmotic stimulation. Absence of the posterior pituitary bright spot on T-1 weighted midsagittal magnetic resonance imaging (MRI) of the brain. Given written informed consent prior to any trial-related procedure is performed.

The full record lists 10 inclusion and 13 exclusion criteria; among the exclusions: presence or a history of nephrogenic diabetes insipidus or diabetes mellitus; presence of uncorrected hypothyroidism, hypoadrenalism or hypogonadism; abnormalities or disease of the oral cavity that might affect the release and absorption of drug.

How the Study Was Run

The set-up was single-group and open-label.

Being open-label, the Desmopressin study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2011-01 with completion listed for 2011-08.

It ran at 5 sites in Japan (5).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change from Baseline in 24-hour Urine Volume (time frame: Day 0, Week 4).

It also tracked 7 secondary outcomes, for example 24-hour urine volume (mL), Hourly diuresis rate (mL/hr), Urine specific gravity (g/mL), Percentage of participants within normal range for urinary output, urinary osmolality and urine specific gravity, Serum sodium level and Participants with Adverse Events Summarized by Incidence and Severity.

What This Means in Plain Language

Put simply, this is a phase 3 trial of Desmopressin in 20 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Desmopressin compound page, all human trials.