pulses study

• Conditions: Addison's disease and Congenital Adrenal Hyperplasia; MedDRA version: 17.0Level: LLTClassification code 10011195Term: CortisolSystem Organ Class: 100000004848; MedDRA version: 17.0Level: LLTClassification code 10020518Term: HydrocortisoneSystem Organ Class: 100000004848; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2012-001104-37-GB
• Lead Sponsor: niversity Hospitals Bristol NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07-24
• Last Update Posted: 23 March 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

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
Dyslexia

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified