Pharmacokinetics of Hydrocortisone After Subcutaneous Administration in Chronic Adrenal Insufficiency
Information source: University of Wuerzburg
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Primary Adrenal Insufficiency
Intervention: Hydrocortisone intramuscular first (Drug); Hydrocortisone subcutaneously first (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Bruno Allolio Official(s) and/or principal investigator(s):
Stefanie Hahner, MD, Principal Investigator, Affiliation: University Hospital Wuerzburg, Germany
Summary
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.
Clinical Details
Official title: Pharmacokinetics of Hydrocortisone After Subcutaneous Administration Compared With Intramuscular Injection in Chronic Adrenal Insufficiency
Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Bioequivalence Study
Secondary outcome: safety
Eligibility
Minimum age: 18 Years.
Maximum age: 64 Years.
Gender(s): Both.
Criteria:
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)
Locations and Contacts
Dept of Medicine I, Endocrinology and Diabetology, University Hospital Wuerzburg, Wuerzburg 97080, Germany
Additional Information
Starting date: November 2011
Last updated: July 31, 2012
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