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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-002687-25 | EudraCT Number |
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Patients with chronic adrenal insufficiency need to adapt their hydrocortisone replacement dose in conditions of physical or psychological stress to prevent life threatening adrenal crisis. In cases of more severe impairment or unsecure gastrointestinal absorption (e.g. gastroenteritis, severe infectious disease), parenteral administration of the hydrocortisone dose is crucial. The study is conducted to offer patients the possibility to perform hydrocortisone self administration in emergency situations in a way of administration which is easy to perform and accepted by the patient. Therefore, pharmacokinetics and safety of subcutaneous hydrocortisone administration will be studied and compared to intramuscular administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hydrocortisone subcutaneously first | Active Comparator | Hydrocortisone subcutaneously first |
|
| Hydrocortisone intramuscular first | Active Comparator | Hydrocortisone intramuscular first |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydrocortisone intramuscular first | Drug | Hydrocortisone intramuscular first |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bioequivalence Study | pharmakokinetic data (Cmax, time to Cmax, area under the curve of serum/salivary cortisol levels) | 4 hours |
| Measure | Description | Time Frame |
|---|---|---|
| safety | number of adverse events after subcutaneous administration of hydrocortisone | 3 days |
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Inclusion Criteria:
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Stefanie Hahner, MD | University Hospital Wuerzburg, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept of Medicine I, Endocrinology and Diabetology, University Hospital Wuerzburg | Würzburg | 97080 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23672956 | Derived | Hahner S, Burger-Stritt S, Allolio B. Subcutaneous hydrocortisone administration for emergency use in adrenal insufficiency. Eur J Endocrinol. 2013 Jun 29;169(2):147-54. doi: 10.1530/EJE-12-1057. Print 2013 Aug. |
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| ID | Term |
|---|---|
| D000224 | Addison Disease |
| D000309 | Adrenal Insufficiency |
| ID | Term |
|---|---|
| D000307 | Adrenal Gland Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D006854 | Hydrocortisone |
| D012997 | Solvents |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| Hydrocortisone subcutaneously first | Drug | Hydrocortisone subcutaneously first |
|
|
| 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 |
| D020313 | Specialty Uses of Chemicals |
| D020164 | Chemical Actions and Uses |