Pharmacokinetics of Hydrocortisone After Subcutaneous Administration in Chronic Adrenal Insufficiency

Phase 2

Completed

• Conditions: Primary Adrenal Insufficiency
• Interventions: Drug: Hydrocortisone subcutaneously first; Drug: Hydrocortisone intramuscular first

• Registration Number: NCT01450930
• Lead Sponsor: Bruno Allolio

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-09-29
• Study First Submitted QC: 2011-10-12
• Study First Posted: 2011-10-13
• Study Start: 2011-11
• Status Verified: 2012-07
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Last Update Submitted: 2012-07-31
• Last Update Posted: 2012-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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)

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Hydrocortisone subcutaneously first	Hydrocortisone subcutaneously first	Hydrocortisone subcutaneously first
Hydrocortisone intramuscular first	Hydrocortisone intramuscular first	Hydrocortisone intramuscular first

Primary Outcome Measures

Name	Time	Method
Bioequivalence Study	4 hours	pharmakokinetic data (Cmax, time to Cmax, area under the curve of serum/salivary cortisol levels)

Secondary Outcome Measures

Name	Time	Method
safety	3 days	number of adverse events after subcutaneous administration of hydrocortisone

Trial Locations

Locations (1)

Dept of Medicine I, Endocrinology and Diabetology, University Hospital Wuerzburg; 🇩🇪 Wuerzburg, Germany