Primary Adrenal Insufficiency Clinical Trial
— PHYSCAOfficial title:
Pharmacokinetics of Hydrocortisone After Subcutaneous Administration Compared With Intramuscular Injection in Chronic Adrenal Insufficiency
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.
Status | Completed |
Enrollment | 12 |
Est. completion date | July 2012 |
Est. primary completion date | July 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 64 Years |
Eligibility |
Inclusion Criteria: - Primary adrenal insufficiency under standard glucocorticoid replacement therapy due to autoimmune adrenalitis or bilateral adrenalectomy (disease duration at least 12 months), - age = 18 years, - Patient´s written informed consent, - Ability to comply with the protocol procedures Exclusion criteria - Diabetes mellitus, - Infectious disease with fever at time of investigation, - Known intolerance to the study drug or constituents oft he study drug, - Oral contraception, - Known pregnancy or breast feeding, - Renal failure (creatinine > 2.5 ULN) |
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Germany | Dept of Medicine I, Endocrinology and Diabetology, University Hospital Wuerzburg | Wuerzburg |
Lead Sponsor | Collaborator |
---|---|
Bruno Allolio |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Bioequivalence Study | pharmakokinetic data (Cmax, time to Cmax, area under the curve of serum/salivary cortisol levels) | 4 hours | No |
Secondary | safety | number of adverse events after subcutaneous administration of hydrocortisone | 3 days | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
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