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Pharmacokinetics of Hydrocortisone After Subcutaneous Administration in Chronic Adrenal Insufficiency

NCT ID: NCT01450930

Last Updated: 2012-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2012-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Primary Adrenal Insufficiency

Keywords

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Adrenal insufficiency Addison's disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Hydrocortisone subcutaneously first

Hydrocortisone subcutaneously first

Group Type ACTIVE_COMPARATOR

Hydrocortisone subcutaneously first

Intervention Type DRUG

Hydrocortisone subcutaneously first

Hydrocortisone intramuscular first

Hydrocortisone intramuscular first

Group Type ACTIVE_COMPARATOR

Hydrocortisone intramuscular first

Intervention Type DRUG

Hydrocortisone intramuscular first

Interventions

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Hydrocortisone intramuscular first

Hydrocortisone intramuscular first

Intervention Type DRUG

Hydrocortisone subcutaneously first

Hydrocortisone subcutaneously first

Intervention Type DRUG

Other Intervention Names

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100 mg hydrocortisone (Pfizer®) in 2 ml solvent 100 mg hydrocortisone (Pfizer®) in 2 ml solvent

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bruno Allolio

OTHER

Sponsor Role lead

Responsible Party

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Bruno Allolio

MD, Professor of Medicine, head of the Dept. of Endocrinology and Diabetology, University of Wuerzburg

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Stefanie Hahner, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Wuerzburg, Germany

Locations

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

Würzburg, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 23672956 (View on PubMed)

Other Identifiers

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2011-002687-25

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

PHYSCA-1

Identifier Type: -

Identifier Source: org_study_id