drugset / Trial / NCT03210545
A Study of Markers of Glucocorticoid Effects in Patients With Addisons Disease (DOSCORT)
RandomizedCrossoverDouble-blindTreatment
Summary
DOSCORT is a 2-dose, cross-over study primarily aiming to identify and validate novel biological markers (biomarkers) of glucocorticoid effect in the human body. Patients with Addison´s disease, primary adrenal insufficiency, with life-long glucocorticoid replacement therapy will undergo 2 treatment periods where their usual hydrocortisone treatment will be replaced with betamethasone in physiological and supra physiological doses. Blood, saliva, urine, health related Quality-of-life self-assessment forms, measurements of physical activity and sleep quality will be collected from both treatment periods.
Timeline
- Start
- 2021-03-02
- Primary completion
- 2021-11-09
- Completion
- 2022-02-16
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Betamethasone | Other / unclassified | — | — |