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Comparison of Intramuscular and Intravenous ACTH Stimulation Test in Normal Volunteers
Plain-language guide to NCT03752190: phase 4 interventional trial of Cosyntropin. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT03752190
- Phase
- phase 4
- Status
- withdrawn
- Start
- 2019-07
- Completion (planned or actual)
- 2020-09-30
- Participants
- n/a (actual)
- Design
- na, open label (everyone knows who gets what), diagnostic
- Conditions studied
- Adrenal Insufficiency
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 4) is built around Cosyntropin.
Cosyntropin (synthetic ACTH) stimulation test is considered the optimal test for diagnosis of primary and long-standing secondary adrenal insufficiency.
Serum cortisol is measured before, and at 30 and 60 minutes after the bolus injection.
It had 1 arm (groups): Intravenous and intramuscular administration (experimental).
Subjects will receive intravenous and intramuscular ACTH on different days.
The registry classes the interventions as drug.
More on the Plan
Investigators will conduct a study looking at healthy subjects to establish the expected range of peak cosyntropin-stimulated cortisol levels in normal healthy subjects with two different cosyntropin administration modalities.
The new Cortisol II assay is also a competitive immunoassay, but employs a monoclonal as opposed to a polyclonal capturing antibody, which was used in the old Cortisol I assay.
This results in greater specificity for cortisol with less interference from other endogenous or exogenous glucocorticoids.
This is a prospective study on healthy subjects.
Who 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.
How the Study Was Run
Design: single-group and open-label.
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 2019-07 with completion listed for 2020-09-30.
Its stated primary purpose is diagnostic.
What Was Measured
Researchers chose this as the main measure: peak serum cortisol (time frame: 60 minutes).
What This Means in Plain Language
Put simply, this is a phase 4 trial of Cosyntropin in people.
It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Cosyntropin compound page, all human trials.
Our Notes on the Compound
Cosyntropin: A synthetic 24-amino-acid fragment of ACTH (also tetracosactide, Synacthen) used mainly in the adrenal stimulation test.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.