NCT01450930

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Nov 2011

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 29, 2011

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 13, 2011

Completed
19 days until next milestone

Study Start

First participant enrolled

November 1, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

August 1, 2012

Status Verified

July 1, 2012

Enrollment Period

8 months

First QC Date

September 29, 2011

Last Update Submit

July 31, 2012

Conditions

Primary Adrenal Insufficiency

Keywords

Adrenal insufficiencyAddison's disease

Outcome Measures

Primary Outcomes (1)

  • Bioequivalence Study

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

    4 hours

Secondary Outcomes (1)

  • safety

    3 days

Study Arms (2)

Hydrocortisone subcutaneously first

ACTIVE COMPARATOR

Hydrocortisone subcutaneously first

Drug: Hydrocortisone subcutaneously first

Hydrocortisone intramuscular first

ACTIVE COMPARATOR

Hydrocortisone intramuscular first

Drug: Hydrocortisone intramuscular first

Interventions

Hydrocortisone intramuscular firstDRUG

Hydrocortisone intramuscular first

Also known as: 100 mg hydrocortisone (Pfizer®) in 2 ml solvent
Hydrocortisone intramuscular first
Hydrocortisone subcutaneously firstDRUG

Hydrocortisone subcutaneously first

Also known as: 100 mg hydrocortisone (Pfizer®) in 2 ml solvent
Hydrocortisone subcutaneously first

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Würzburg, 97080, Germany

Location

Related Publications (1)

  • 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.

    PMID: 23672956DERIVED

MeSH Terms

Conditions

Addison DiseaseAdrenal Insufficiency

Interventions

HydrocortisoneSolvents

Condition Hierarchy (Ancestors)

Adrenal Gland DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds11-HydroxycorticosteroidsHydroxycorticosteroidsAdrenal Cortex HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists17-HydroxycorticosteroidsSpecialty Uses of ChemicalsChemical Actions and Uses

Study Officials

  • Stefanie Hahner, MD

    University Hospital Wuerzburg, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, Professor of Medicine, head of the Dept. of Endocrinology and Diabetology, University of Wuerzburg

Study Record Dates

First Submitted

September 29, 2011

First Posted

October 13, 2011

Study Start

November 1, 2011

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

August 1, 2012

Record last verified: 2012-07

Locations

DE(1)