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Pharmacokinetics of Hydrocortisone After Subcutaneous Administration in Chronic Adrenal Insufficiency

Information source: University of Wuerzburg
Information obtained from ClinicalTrials.gov on December 08, 2011
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: Not yet recruiting

Sponsored by: Bruno Allolio

Official(s) and/or principal investigator(s):
Stefanie Hahner, MD, Principal Investigator, Affiliation: University Hospital Wuerzburg, Germany

Overall contact:
Stefanie Hahner, MD, Phone: +49 931 201 1, Email: hahner_s@medizin.uni-wuerzburg.de

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

Stefanie Hahner, MD, Phone: +49 931 201 1, Email: hahner_s@medizin.uni-wuerzburg.de

Dept of Medicine I, Endocrinology and Diabetology, University Hospital Wuerzburg, Wuerzburg 97080, Germany
Additional Information

Starting date: November 2011
Last updated: October 12, 2011

Page last updated: December 08, 2011

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