PHYSCA: Pharmacokinetics of Hydrocortisone After Subcutaneous Administration in Chronic Adrenal Insufficiency

• Sponsor: Bruno Allolio (Other)
• Overall Status: Completed
• CT.gov ID: NCT01450930
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Arms: 2
• Duration (Months): 8
• Patients Per Site Per Month: 1.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Primary Adrenal Insufficiency	Drug: Hydrocortisone intramuscular first; Drug: Hydrocortisone subcutaneously first	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Pharmacokinetics of Hydrocortisone After Subcutaneous Administration Compared With Intramuscular Injection in Chronic Adrenal Insufficiency
• Study Start Date: Nov 1, 2011
• Actual Primary Completion Date: Jul 1, 2012
• Actual Study Completion Date: Jul 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Hydrocortisone subcutaneously first 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 Hydrocortisone intramuscular first	Drug: Hydrocortisone intramuscular first; Hydrocortisone intramuscular first; Other Names: 100 mg hydrocortisone (Pfizer®) in 2 ml solvent

Outcome Measures

Primary Outcome Measures

1. Bioequivalence Study [4 hours]

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

Secondary Outcome Measures

1. safety [3 days]

   number of adverse events after subcutaneous administration of hydrocortisone

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 64 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dept of Medicine I, Endocrinology and Diabetology, University Hospital Wuerzburg	Wuerzburg		Germany	97080

Sponsors and Collaborators

• Bruno Allolio

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bruno Allolio, MD, Professor of Medicine, head of the Dept. of Endocrinology and Diabetology, University of Wuerzburg, University of Wuerzburg
• ClinicalTrials.gov Identifier: NCT01450930
• Other Study ID Numbers: PHYSCA-1; 2011-002687-25
• First Posted: Oct 13, 2011
• Last Update Posted: Aug 1, 2012
• Last Verified: Jul 1, 2012

• Keywords provided by Bruno Allolio, MD, Professor of Medicine, head of the Dept. of Endocrinology and Diabetology, University of Wuerzburg, University of Wuerzburg: Adrenal insufficiency; Addison's disease
• Additional relevant MeSH terms: Adrenal Insufficiency; Addison Disease; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Hydrocortisone hemisuccinate

Study Results

No Results Posted as of Aug 1, 2012