Pharmacokinetics of Hydrocortisone After Subcutaneous Administration in Chronic Adrenal Insufficiency

Primary Adrenal Insufficiency Clinical Trial

— PHYSCA  

Official title:

Pharmacokinetics of Hydrocortisone After Subcutaneous Administration Compared With Intramuscular Injection in Chronic Adrenal Insufficiency

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01450930
• Other study ID #: PHYSCA-1
• Secondary ID: 2011-002687-25
• Status: Completed
• Phase: Phase 2
• First received: September 29, 2011
• Last updated: July 31, 2012
• Start date: November 2011
• Est. completion date: July 2012

Study information

• Verified date: July 2012
• Source: University of Wuerzburg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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)

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Addison Disease
• Adrenal Insufficiency
• Primary Adrenal Insufficiency

Intervention

Drug:
• Hydrocortisone intramuscular first
Hydrocortisone intramuscular first
• Hydrocortisone subcutaneously first
Hydrocortisone subcutaneously first

Locations

Country	Name	City	State
Germany	Dept of Medicine I, Endocrinology and Diabetology, University Hospital Wuerzburg	Wuerzburg

Sponsors (1)

Lead Sponsor	Collaborator
Bruno Allolio

Country where clinical trial is conducted

Germany, 

Outcome

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