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OpenTrials
Completed

NCT Number: NCT01450930

Pharmacokinetics of Hydrocortisone After Subcutaneous Administration in Chronic Adrenal Insufficiency

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.

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Key information

Conditions

Primary Adrenal Insufficiency Addison Disease Adrenal Gland Diseases Adrenal Insufficiency Autoimmune Diseases Endocrine System Diseases Immune System Diseases

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

Würzburg, 97080, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Hydrocortisone intramuscular first

Drug

Hydrocortisone intramuscular first

Other names: 100 mg hydrocortisone (Pfizer®) in 2 ml solvent

Hydrocortisone subcutaneously first

Drug

Hydrocortisone subcutaneously first

Other names: 100 mg hydrocortisone (Pfizer®) in 2 ml solvent

Primary outcomes

  1. Bioequivalence Study

    Time frame: 4 hours

    pharmakokinetic data (Cmax, time to Cmax, area under the curve of serum/salivary cortisol levels)

Secondary outcomes

  1. safety

    Time frame: 3 days

    number of adverse events after subcutaneous administration of hydrocortisone

Sponsors and collaborators

Lead sponsor

Bruno Allolio

Other

Registry information

Official study title

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

Acronym: PHYSCA

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Oct 13, 2011
Registry last updated
Aug 1, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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