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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bruno Allolio, University of Wuerzburg
ClinicalTrials.gov Identifier:
NCT01450930
First received: September 29, 2011
Last updated: July 31, 2012
Last verified: July 2012
History of Changes
  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
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: 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:

MedlinePlus related topics: Addison Disease
U.S. FDA Resources

Further study details as provided by University of Wuerzburg:

Primary Outcome Measures:
  • Bioequivalence Study [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
    pharmakokinetic data (Cmax, time to Cmax, area under the curve of serum/salivary cortisol levels)


Secondary Outcome Measures:
  • safety [ Time Frame: 3 days ] [ Designated as safety issue: Yes ]
    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
Genders Eligible for Study:   Both
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
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

No publications provided

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
Study First Received: September 29, 2011
Last Updated: July 31, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by 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
Cortisol succinate
Hydrocortisone acetate
 Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone
Hydrocortisone-17-butyrate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Dermatologic Agents

ClinicalTrials.gov processed this record on May 16, 2013