Value of [amount hidden] Cortrosyn Stimulation Test

What Was Tested

The trial (not phased) is built around Cosyntropin.

It had two arms (groups): Patients (active comparator) and Volunteers (active comparator).

The registry classes the interventions as procedure.

More on the Plan

The study consisted of two groups of adult patients 18 to 65 years of age.

The first group (G1, n=10) included patients with hypothalamic/pituitary disease with at least one pituitary axis deficiency other than ACTH deficiency.

The patients had the following diagnoses: acromegaly (n=1), prolactinoma (n=2), non-secreting pituitary macroadenomas (n=3), pituitary cholesterol granuloma (1), uncharacterized pituitary stalk lesion(1),recurrent null cell adenoma(1) and craniopharyngioma (n=1).

The second group (G2, n=12) comprised healthy volunteers.

Who Took Part

22 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

Healthy volunteers could join, not only people with the condition.

The full record lists 1 inclusion and 1 exclusion criteria; among the exclusions: under 18 or older than 65 years of age.

How the Study Was Run

The set-up was randomized, crossover and open-label.

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

In the crossover set-up each of the participants took both Cosyntropin and the comparison in turn, acting as their own control.

Nothing was hidden in this open-label Cosyntropin study: the participants and staff both knew the treatment.

It started in 2011-09 with completion listed for 2015-01.

It ran at 1 site in United States.

Its stated primary purpose is diagnostic.

What Was Measured

Primary outcome: Pearson Correlation of the Total Cortisol Levels Between the ITT and CSTs (time frame: 1 hour for the CST interventions and 2 hour for the ITT interventions).

It also tracked 2 secondary outcomes, for example Pearson Correlation of Free Cortisol Values During CSTs With ITT and Peak Total Cortisol Values.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Cosyntropin in 22 people.

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

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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