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

niversity Hospitals Bristol NHS Foundation Trust0 个研究点开始时间: 2014年7月24日最近更新: 2015年3月23日

适应症

试验速览

暂无简介。

•Male and female patients with confirmed Addison’s disease and CAH
•Aged 18 to 64 years
•Females of child bearing potential must be using a highly effective method of contraception / birth control as defined in ICH (M3) if sexually active
•Right handed
•Able to give informed consent
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 20
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range 0

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

发起方

niversity Hospitals Bristol NHS Foundation Trust