drugset / Trial / NCT03210545

A Study of Markers of Glucocorticoid Effects in Patients With Addisons Disease (DOSCORT)

NCT03210545

Phase 4 Completed 30 enrolled Göteborg University
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

EvaluationDrugModalityDoseRoute
Comparator Betamethasone Other / unclassified