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

July 31, 2012 updated by: Bruno Allolio

Pharmacokinetics of Hydrocortisone After Subcutaneous Administration Compared With Intramuscular Injection 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Hydrocortisone subcutaneously first
Drug: Hydrocortisone subcutaneously first
Hydrocortisone subcutaneously first
Other Names:
  • 100 mg hydrocortisone (Pfizer®) in 2 ml solvent
ACTIVE_COMPARATOR: Hydrocortisone intramuscular first
Drug: Hydrocortisone intramuscular first
Hydrocortisone intramuscular first
Other Names:
  • 100 mg hydrocortisone (Pfizer®) in 2 ml solvent

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
safety
Time Frame: 3 days
number of adverse events after subcutaneous administration of hydrocortisone
3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bruno Allolio

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (ACTUAL)

July 1, 2012

Study Completion (ACTUAL)

July 1, 2012

Study Registration Dates

First Submitted

September 29, 2011

First Submitted That Met QC Criteria

October 12, 2011

First Posted (ESTIMATE)

October 13, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

August 1, 2012

Last Update Submitted That Met QC Criteria

July 31, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PHYSCA-1
  • 2011-002687-25 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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