Pharmacokinetics of Hydrocortisone After Subcutaneous Administration in Chronic Adrenal Insufficiency - Full Text View

Purpose

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	Intervention	Phase
Primary Adrenal Insufficiency	Drug: Hydrocortisone intramuscular first Drug: Hydrocortisone subcutaneously first	Phase 2


Study Type:	Interventional
Study Design:	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

Resource links provided by NLM:

Genetics Home Reference related topics: autoimmune Addison disease familial glucocorticoid deficiency

MedlinePlus related topics: Addison Disease

Drug Information available for: Hydrocortisone acetate Hydrocortisone Hydrocortisone sodium succinate Hydrocortisone cypionate Hydrocortisone valerate Hydrocortisone probutate Proctofoam-HC

Genetic and Rare Diseases Information Center resources: Addison's Disease Hypoadrenalism

U.S. FDA Resources

Further study details as provided by Bruno Allolio, University of Wuerzburg:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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


Enrollment:	12
Study Start Date:	November 2011
Study Completion Date:	July 2012
Primary Completion Date:	July 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility


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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01450930

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

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 )
Study First Received:	September 29, 2011
Last Updated:	July 31, 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 Cortisol succinate Hydrocortisone acetate 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

ClinicalTrials.gov processed this record on August 17, 2017

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