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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Solu-Cortef® in deltoid muscle | Experimental | Solu-Cortef® in deltoid muscle |
|
| Solu-Cortef® in thigh muscle | Experimental | Solu-Cortef® in thigh muscle |
|
| Hydrocortisone 100mg/ml in deltoid muscle | Experimental | Hydrocortisone 100mg/ml in deltoid muscle |
|
| Hydrocortisone 100mg/ml in thigh muscle | Experimental | Hydrocortisone 100mg/ml in thigh muscle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Solu-Cortef 100 MG Injection | Drug | Licensed medicine used in clinical practice. Preparations will be used unmodified in this trial withinmarketing authorisations. |
|
| Measure | Description | Time Frame |
|---|---|---|
| State of Hypocortisolaemia when injected into deltoid muscle or thigh muscle | Measure of Peak Serum Cortisol | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 4 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christine Topham | Contact | 0203 219 3570 | clinicalresearch@thelondonclinic.co.uk | |
| Phillip Yeoh | Contact | 0207 953 4444 |
| Name | Affiliation | Role |
|---|---|---|
| Pierre Bouloux | Endocrinology Consultant | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The London Clinic | Recruiting | London | W1G 6HL | United Kingdom |
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| ID | Term |
|---|---|
| D000224 | Addison Disease |
| ID | Term |
|---|---|
| D000309 | Adrenal Insufficiency |
| D000307 | Adrenal Gland Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
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| ID | Term |
|---|---|
| C007133 | hydrocortisone hemisuccinate |
| D007267 | Injections |
| D006854 | Hydrocortisone |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D011282 | Pregnenediones |
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| Hydrocortisone 100mg/ml | Drug | Licensed medicine used in clinical practice. Preparations will be used unmodified in this trial within marketing authorisations. |
|
| 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 | 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 | 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 | 5 Weeks |
| D007154 | Immune System Diseases |
| D011283 |
| Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D015062 | 11-Hydroxycorticosteroids |
| D006889 | Hydroxycorticosteroids |
| D000305 | Adrenal Cortex Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D015065 | 17-Hydroxycorticosteroids |