The study will be looking at the cortisol profiles of hypocortisolaemic patients following 100mg injections of two hydrocortisone preparations (Solu-Cortef® \& Hydrocortisone 100mg/ml). The investigators plan to use two methods of intramuscular injection to administer the preparations, one using a 1inch orange needle into the deltoid muscle and the other using a 1.25inch blue needle into the thigh muscle.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
8
Licensed medicine used in clinical practice. Preparations will be used unmodified in this trial withinmarketing authorisations.
Licensed medicine used in clinical practice. Preparations will be used unmodified in this trial within marketing authorisations.
The London Clinic
London, United Kingdom
RECRUITINGState of Hypocortisolaemia when injected into deltoid muscle or thigh muscle
Measure of Peak Serum Cortisol
Time frame: 4 weeks
Pain perception following use of difference sizes of needles (1inch orange needle versus 1.25inch blue needle), muscle groups (deltoid versus thigh) and hydrocortisone preparations (Solu-Cortef® versus Hydrocortisone 100mg/ml)
Verbal Numerical Rating Scale for Pain from 0 (no pain) to 10 (worst pain) Size of needle Injection site used Hydrocortisone preparation
Time frame: 4 Weeks
Hydrocortisone absorption
Measured by Injection site circumference measured in Centimeters and BMI (weight in kilograms, height in meters) BMI combined to view Area under curve and Time to peak concentration
Time frame: 4 Weeks
Ability to Self-Inject
Measure by assessment of the following: Hypocortisolaemia symptoms Leftover IMP in ampoules (Quanitity of IMP measure in ml to calculate remaining mg of IMP) Time taken to inject
Time frame: 4 Weeks
Subjective health status/impact on quality of life
AddiQol score (AddiQol Health-related quality of life in Addison's disease) total score 30 Ability to self-inject
Time frame: 5 Weeks
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