Pulsed glucocorticoid replacement therapy for patients with adrenocortical insufficiency secondary to Addison’s disease and congenital adrenal hyperplasia

niversity Hospitals Bristol NHS Foundation Trust0 个研究点目标入组 21 人开始时间: 2014年12月3日最近更新: 2023年10月30日

适应症

试验速览

2023 Results article in https://doi.org/10.1111/joim.13721 (added 20/10/2023)

•1. Male and female patients with confirmed Addison’s disease and CAH
•2. Aged 18 to 64 years
•3. Females of child bearing potential must be using a highly effective method of contraception / birth control as defined in ICH (M3) if sexually active
•4. Right handed
•5. Able to give informed consent

•1. Any significant current cerebral, cardiovascular, respiratory, hepatobiliary, pancreatic disease, renal dysfunction, gastrointestinal emptying or motility disturbances.
•2. No current treatment or within the last 3 months of another underlying disease that could necessitate treatment with glucocorticoids
•3. Taking of medications that interfere with cortisol metabolism (antiepileptics, St Johns wart, rifampicin)
•4. Diagnosis of Addison’s disease less than 6 months ago
•5. Pregnant or lactating women
•6. Greater than 21 units of alcohol per week
•7. Taking of any investigational drug within the past two months
•8. Known allergy to any of the study medications and /or materials used in the pump
•9. Needle phobia
•10. Contraindication to fMRI scan i.e. metal implant/shrapnel
•11. Claustrophobia
•12. Left handed/significant ambidexterity
•13. Dyslexia

发起方

niversity Hospitals Bristol NHS Foundation Trust