- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01450930
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
-
-
-
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
|
Hydrocortisone subcutaneously first
Other Names:
|
ACTIVE_COMPARATOR: Hydrocortisone intramuscular first
|
Hydrocortisone intramuscular first
Other Names:
|
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
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.
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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