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

Primary Purpose

Primary Adrenal Insufficiency

Status

Completed

Phase

Phase 2

Locations

Germany

Study Type

Interventional

Intervention

Hydrocortisone intramuscular first

Hydrocortisone subcutaneously first

About this trial

This is an interventional treatment trial for Primary Adrenal Insufficiency focused on measuring Adrenal insufficiency, Addison's disease

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Hydrocortisone subcutaneously first

Hydrocortisone intramuscular first

Arm Description

Hydrocortisone subcutaneously first

Hydrocortisone intramuscular first

Outcomes

Primary Outcome Measures

Bioequivalence Study

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

Secondary Outcome Measures

safety

number of adverse events after subcutaneous administration of hydrocortisone

Full Information

NCT ID

NCT01450930

First Posted

September 29, 2011

Last Updated

July 31, 2012

Sponsor

Bruno Allolio

1. Study Identification

Unique Protocol Identification Number

NCT01450930

Brief Title

Pharmacokinetics of Hydrocortisone After Subcutaneous Administration in Chronic Adrenal Insufficiency

Acronym

PHYSCA

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2012

Overall Recruitment Status

Completed

Study Start Date

November 2011 (undefined)

Primary Completion Date

July 2012 (Actual)

Study Completion Date

July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Bruno Allolio

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Primary Adrenal Insufficiency

Keywords

Adrenal insufficiency, Addison's disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Hydrocortisone subcutaneously first

Arm Type

Active Comparator

Arm Description

Hydrocortisone subcutaneously first

Arm Title

Hydrocortisone intramuscular first

Arm Type

Active Comparator

Arm Description

Hydrocortisone intramuscular first

Intervention Type

Drug

Intervention Name(s)

Hydrocortisone intramuscular first

Other Intervention Name(s)

100 mg hydrocortisone (Pfizer®) in 2 ml solvent

Intervention Description

Hydrocortisone intramuscular first

Intervention Type

Drug

Intervention Name(s)

Hydrocortisone subcutaneously first

Other Intervention Name(s)

100 mg hydrocortisone (Pfizer®) in 2 ml solvent

Intervention Description

Hydrocortisone subcutaneously first

Primary Outcome Measure Information:

Title

Bioequivalence Study

Description

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

Time Frame

4 hours

Secondary Outcome Measure Information:

Title

safety

Description

number of adverse events after subcutaneous administration of hydrocortisone

Time Frame

3 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

Eligibility 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Stefanie Hahner, MD

Organizational Affiliation

University Hospital Wuerzburg, Germany

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Wuerzburg

ZIP/Postal Code

97080

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

23672956

Citation

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.

Results Reference

derived

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Pharmacokinetics of Hydrocortisone After Subcutaneous Administration in Chronic Adrenal Insufficiency

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