Pharmacokinetics of Hydrocortisone After Subcutaneous Administration in Chronic Adrenal Insufficiency (PHYSCA)

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Primary Adrenal Insufficiency	Drug: Hydrocortisone intramuscular first; Drug: Hydrocortisone subcutaneously first	Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	12 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Pharmacokinetics of Hydrocortisone After Subcutaneous Administration Compared With Intramuscular Injection in Chronic Adrenal Insufficiency
Study Start Date :	November 2011
Actual Primary Completion Date :	July 2012
Actual Study Completion Date :	July 2012

Arms and Interventions

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Arm	Intervention/treatment
Active Comparator: Hydrocortisone subcutaneously first; Hydrocortisone subcutaneously first	Drug: Hydrocortisone subcutaneously first; Hydrocortisone subcutaneously first; Other Name: 100 mg hydrocortisone (Pfizer®) in 2 ml solvent
Active Comparator: Hydrocortisone intramuscular first; Hydrocortisone intramuscular first	Drug: Hydrocortisone intramuscular first; Hydrocortisone intramuscular first; Other Name: 100 mg hydrocortisone (Pfizer®) in 2 ml solvent

Outcome Measures

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Primary Outcome Measures :

1. Bioequivalence Study [ Time Frame: 4 hours ]
   pharmakokinetic data (Cmax, time to Cmax, area under the curve of serum/salivary cortisol levels)

Secondary Outcome Measures :

1. safety [ Time Frame: 3 days ]
   number of adverse events after subcutaneous administration of hydrocortisone

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 64 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

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Locations

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

Sponsors and Collaborators

Bruno Allolio

Investigators

Principal Investigator:	Stefanie Hahner, MD	University Hospital Wuerzburg, Germany

More Information

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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Hahner S, Burger-Stritt S, Allolio B. Subcutaneous hydrocortisone administration for emergency use in adrenal insufficiency. Eur J Endocrinol. 2013 Jun 29;169(2):147-54. doi: 10.1530/EJE-12-1057. Print 2013 Aug.

Responsible Party:	Bruno Allolio, MD, Professor of Medicine, head of the Dept. of Endocrinology and Diabetology, University of Wuerzburg, University of Wuerzburg
ClinicalTrials.gov Identifier:	NCT01450930 History of Changes
Other Study ID Numbers:	PHYSCA-1; 2011-002687-25 ( EudraCT Number )
First Posted:	October 13, 2011
Last Update Posted:	August 1, 2012
Last Verified:	July 2012

Keywords provided by Bruno Allolio, University of Wuerzburg:

Adrenal insufficiency; Addison's disease

Additional relevant MeSH terms:

Addison Disease; Adrenal Insufficiency; Adrenal Gland Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Cortisol succinate; Hydrocortisone; Epinephrine; Racepinephrine; Epinephryl borate; Anti-Inflammatory Agents; Adrenergic alpha-Agonists	Adrenergic Agonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs; Adrenergic beta-Agonists; Bronchodilator Agents; Autonomic Agents; Peripheral Nervous System Agents; Anti-Asthmatic Agents; Respiratory System Agents; Mydriatics; Sympathomimetics; Vasoconstrictor Agents