Determination of Method-specific Normal Cortisol and Adrenal Hormone Responses to the Short Synacthen Test

What Was Tested

In this phase 4 trial, researchers set out to test Cosyntropin.

Objectives: To establish valid serum total cortisol and salivary cut-offs for use with the short Synacthen test in patients with normal CBG concentrations.

To investigate, using current assays, the effect of assay differences on the serum total cortisol cut-off.

To explore the performance of these cut-offs in groups of patients with suspected adrenal insufficiency and high and low serum CBG concentration.

The registry classes the interventions as drug.

More on the Plan

Synacthen® is a synthetic analogue of ACTH which has been used since the 1960s to assess adrenal sufficiency.

It is now well established as a first line test to investigate diseases of the hypothalamo-pituitary-adrenal axis and to assess adrenal function in patients on long-term corticosteroid therapy.

In 2004 the All Wales Clinical Biochemistry Audit group surveyed protocols for performing and interpreting short Synacthen® tests.

Who Took Part

The registry lists 165 actual participants took part.

It was open to people of any sex aged from 18 years up to 80 years.

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

Examples of who could join: Volunteers will be in self-proclaimed good health. Volunteers will be free of illness on the day of testing. Volunteers will not be taking drug therapy. Patients will be free of intercurrent illness on the day of testing. Patients will have a confirmed diagnosis of hypoadrenalism or hypopituitarism.

The full record lists 5 inclusion and 8 exclusion criteria; among the exclusions: is using corticosteroids,; has a history of thyroid or other autoimmune disease,; has a previous history of hypersensitivity to synacthen®,.

How the Study Was Run

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

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

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

It started in 2008-09 with completion listed for 2012-07-28.

It ran at 1 site in United Kingdom.

Its stated primary purpose is diagnostic.

What Was Measured

The main thing measured (primary outcome): The primary end-point of the study will be to establish method dependent cortisol cut offs for the normal response to Synacthen® using the 5th percentile (time frame: Cortisol response at 30 minutes).

It also tracked 4 secondary outcomes, for example Synacthen® responses in women taking ethinyloestradiol-containing contraceptive pills will be compared with those who are not, We will establish cut offs for the salivary cortisol response to Synacthen® in normal volunteers using the 5th percentile and We will establish a 17OHP cut off in response to Synacthen® in normal female volunteers using the 5th percentile.

What This Means in Plain Language

Put simply, this is a phase 4 trial of Cosyntropin in 165 people.

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

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