A Phase 1/2 interventional study of Solu-Cortef and Cortef in Addison Disease and Adrenal Hyperplasia Congenital, sponsored by Haukeland University Hospital. Completed at 1 site in Norway. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-06-07.
Sponsored by Haukeland University Hospital · Phase 1/2, Interventional, and Treatment
The aim of this study is to compare the effects of tablet treatment, circadian and combined circadian and ultradian subcutaneous hydrocortisone infusion on steroid metabolism and tissue responses to therapy.
The conventional glucocorticoid replacement therapy in primary adrenal insufficiency (Addison's disease) and congenital adrenal hyperplasia renders the cortisol levels unphysiological, which may cause symptoms and long-term complications. This therapeutical approach does not enable to restore physiological circadian and ultradian rhythm of glucocorticoids. Current studies conclude that constant or unphysiological administration of glucocorticoids leads to abnormal gene transcription and causes sides effect of glucocorticoids treatment and long standing complications Glucocorticoid replacement is technically feasible by continuous subcutaneous hydrocortisone infusion, which can mimic not only the normal diurnal cortisol rhythm, but potentially also the ultradian cadence.
This is a pilot trial with an open cross-over design of 3 x minimum 2 weeks in 10 patients comparing the effects of tablet treatment versus continuous subcutaneous hydrocortisone infusion versus ultradian subcutaneous hydrocortisone infusion on serum, salivary, tissue hormonal response and glucocorticoid related gene expression.
36 studies on the registry are indexed under Addison Disease; 9 are open to participants now.
This study's enrollment of 8 is below the median of 24 across 25 interventional studies indexed under Addison Disease.
Browse Addison Disease studies →Haukeland University Hospital is the lead sponsor of 284 studies on the registry; 59 are open to participants now.
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Inclusion Criteria:
Exclusion Criteria:.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
continuous subcutaneous hydrocortisone infusion (CSHI), Solu-Cortef ® 50mg/ml infusate
Drug: Solu-Cortef · Drug: Cortef
the patient regular treatment by Cortef 5 mg, produced by Nycomed Pharma two times or three times a day.
Drug: Solu-Cortef · Drug: Cortef
ultradian subcutaneous hydrocortisone infusion, Solu-Cortef ® 50mg/ml infusate
Drug: Solu-Cortef · Drug: Cortef
administration by pump for minimum 2 weeks
Also known as: hydrocortisone
tablet treatment 2 ro 3 times per day for 14 days
Also known as: hydrocortisone tablets
Serum cortisol -24 hours curve
admission to hospital for 24 hours
Time frame: 24 hours
Salivary cortisol - 24 hours curve
admission to the hospital for 25 hours
Time frame: 24 hours
24 h urine cortisol and metabolites
urine samples for 24 hours
Time frame: 24 hours
levels of corticotropic hormone
blood samples
Time frame: 24 hours
24 hours curve of tissue cortisol
The tissue effect of glucocorticoid replacement - 24 hours curve of tissue cortisol (microdialysis)
Time frame: 24 hours
gene expression
m RNA expression of genes
Time frame: 24 hours
This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Hydrocortisone hemisuccinate · Hydrocortisone
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