Overview

This trial is active, not recruiting.

Conditions addison disease, adrenal hyperplasia congenital
Treatments solu-cortef, cortef
Phase phase 1/phase 2
Sponsor Haukeland University Hospital
Start date August 2014
End date December 2016
Trial size 10 participants
Trial identifier NCT02096510, 2013/1738

Summary

The aim of this study is to compare the effects of tablet treatment, circadian and combined circadian and ultradian subcutaneous hydrocortisone infusion on steroid metabolism and tissue responses to therapy.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification pharmacokinetics study
Intervention model crossover assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
continuous subcutaneous hydrocortisone infusion (CSHI), Solu-Cortef ® 50mg/ml infusate
solu-cortef hydrocortisone
administration by pump for minimum 2 weeks
cortef hydrocortisone tablets
tablet treatment 2 ro 3 times per day for 14 days
(Active Comparator)
the patient regular treatment by Cortef 5 mg, produced by Nycomed Pharma two times or three times a day.
solu-cortef hydrocortisone
administration by pump for minimum 2 weeks
cortef hydrocortisone tablets
tablet treatment 2 ro 3 times per day for 14 days
(Experimental)
ultradian subcutaneous hydrocortisone infusion, Solu-Cortef ® 50mg/ml infusate
solu-cortef hydrocortisone
administration by pump for minimum 2 weeks
cortef hydrocortisone tablets
tablet treatment 2 ro 3 times per day for 14 days

Primary Outcomes

Measure
Serum cortisol -24 hours curve
time frame: 24 hours

Secondary Outcomes

Measure
Salivary cortisol - 24 hours curve
time frame: 24 hours
24 h urine cortisol and metabolites
time frame: 24 hours
levels of corticotropic hormone
time frame: 24 hours
24 hours curve of tissue cortisol
time frame: 24 hours
gene expression
time frame: 24 hours

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

Inclusion Criteria: 1. clinical diagnosis of primary adrenal insufficiency 2. Written informed consent Exclusion Criteria:. 1. Diabetes mellitus 2. Severe cardiovascular disease 3. Active malignant disease 4. Pregnancy or breast feeding 5. treatment with interfering drugs 6. Intake of grapefruit juice

Additional Information

Official title Ultradian Subcutaneous Hydrocortisone Infusion in Addison Disease and Congenital Adrenal Hyperplasia
Principal investigator Katerina Simunkova, MD, PhD
Description The conventional glucocorticoid replacement therapy in primary adrenal insufficiency (Addison's disease) and congenital adrenal hyperplasia renders the cortisol levels unphysiological, which may cause symptoms and long-term complications. This therapeutical approach does not enable to restore physiological circadian and ultradian rhythm of glucocorticoids. Current studies conclude that constant or unphysiological administration of glucocorticoids leads to abnormal gene transcription and causes sides effect of glucocorticoids treatment and long standing complications Glucocorticoid replacement is technically feasible by continuous subcutaneous hydrocortisone infusion, which can mimic not only the normal diurnal cortisol rhythm, but potentially also the ultradian cadence. This is a pilot trial with an open cross-over design of 3 x minimum 2 weeks in 10 patients comparing the effects of tablet treatment versus continuous subcutaneous hydrocortisone infusion versus ultradian subcutaneous hydrocortisone infusion on serum, salivary, tissue hormonal response and glucocorticoid related gene expression.
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by Haukeland University Hospital.