CompletedPhase 2

Pharmacokinetics of Hydrocortisone After Subcutaneous Administration in Chronic Adrenal Insufficiency

Germany12 participantsStarted 2011-11

Plain-language 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.

Who can participate

Age range18 Years – 64 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

What they're measuring

Bioequivalence Study

Timeframe: 4 hours

Trial details

NCT IDNCT01450930

SponsorBruno Allolio

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-07

View on ClinicalTrials.gov More Primary Adrenal Insufficiency trials