Optimization of the Evaluation of the Adrenal Function After Discontinuation of a Prolonged Therapy With Corticosteroids

What Was Tested

In this not phased trial, researchers set out to test Cosyntropin.

Indeed, this long test could be realized in ambulatory conditions, and turn out more contributory than the definitive standard to estimate the capacities of answer of the adrenal glands in front of a prolonged stress, as it is the case during a surgical procedure for example.

The registry classes the interventions as biological.

More on the Plan

Synthetic glucocorticoids (GC) are used in the treatment of numerous inflammatory or auto-immune diseases, in particular the intestinal chronic inflammatory diseases (Crohn's disease, chronic ulcerative colitis).

Their protocol of medical research concerns these two complications, and aims at optimizing the evaluation of the adrenal function.

The adrenocortical insufficiency after prolonged corticotherapy is the most frequent cause of secondary adrenocortical insufficiency.

It is due to the braking of the hypothalamo-pituitary-adrenal (HPA) axis which controls the endogenous secretion of cortisol.

Who Took Part

Enrollment: 10 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: Intestinal chronic inflammatory diseases (Crohn's disease, chronic ulcerative colitis). Systemic prolonged treatment with corticosteroids during 2 months at least. Discontinuation of the treatment with corticosteroids for 6 weeks.

The full record lists 4 inclusion and 4 exclusion criteria; among the exclusions: systemic prolonged treatment with corticosteroids because of an other disease than a intestinal chronic inflammatory disease; pregnancy, breast feeding; hypersensibility to synacthene.

How the Study Was Run

It was run as a single-group and open-label study.

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

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

It started in 2010-01 with completion listed for 2012-07.

It ran at 1 site in France.

Its stated primary purpose is diagnostic.

What Was Measured

Researchers chose this as the main measure: To estimate a new test, the "long" synacthen stimulation test, using an IM injection of [amount hidden] of delate synacthen, with regard to the definitive standard.

What This Means in Plain Language

Put simply, this is a not phased trial of Cosyntropin in 10 people.

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

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

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