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Revival of Stem Cells in Addison's Study
Plain-language guide to NCT01371526: phase 4 interventional trial of Cosyntropin, 13 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01371526
- Phase
- phase 4
- Status
- completed
- Start
- 2010-09
- Completion (planned or actual)
- 2012-09
- Participants
- 13 (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Adrenal Failure
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 4 trial tested Cosyntropin.
Autoimmune Addison's disease (AAD) is a rare and debilitating disease in which an autoimmune attack progressively destroys the adrenal cortex.
Untreated it is universally fatal and treated people are absolutely dependent upon steroid medications lifelong, with a consequent excess in morbidity and mortality.
A key feature of the adrenal cortex is that its cells are responsive to changes in circulating adrenocorticotrophic hormone (ACTH) concentration.
It had 1 arm (groups): Synacthen (experimental).
Active treatment.
The registry classes the interventions as drug.
Who Took Part
Enrollment: 13 actual participants took part.
It was open to people of any sex aged from 16 years up to 66 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Established autoimmune adrenal failure for \>1yr age 16 to 65.
The full record lists 1 inclusion and 5 exclusion criteria; among the exclusions: asthma, current infectious disease, recent live vaccination, acute psychosis, peptic ulcer disease; pregnancy, breast feeding or plan for pregnancy within 9 months; known non-autoimmune cause for adrenal failure (haemorrhage, adrenoleukodystrophy etc.).
How the Study Was Run
The set-up was single-group and open-label.
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 2010-09 with completion listed for 2012-09.
It ran at 1 site in United Kingdom.
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Peak serum Cortisol following ACTH stimulation (time frame: Tested at 20 weeks).
It also tracked 1 secondary outcome, for example Change in QoL.
What This Means in Plain Language
Put simply, this is a phase 4 trial of Cosyntropin in 13 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 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.