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Clinical trial

Ultradian Subcutaneous Hydrocortisone Infusion in Addison Disease and Congenital Adrenal Hyperplasia

ID
Name
2013/1738
Description
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.
Trial arms
Trial start
2014-03-27
Estimated PCD
2016-12-01
Trial end
2017-12-01
Status
Completed
Phase
Early phase I
Treatment
Solu-Cortef
administration by pump for minimum 2 weeks
Arms:
continuous subcutaneous hydrocortisone, cortef tablets, ultradian subcutaneous hydrocortisone
Other names:
hydrocortisone
Cortef
tablet treatment 2 ro 3 times per day for 14 days
Arms:
continuous subcutaneous hydrocortisone, cortef tablets, ultradian subcutaneous hydrocortisone
Other names:
hydrocortisone tablets
Size
8
Primary endpoint
Serum cortisol -24 hours curve
24 hours
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 8, 'type': 'ACTUAL'}}
Updated at
2024-06-07

1 organization

2 products

2 indications

Organization
Haukeland University Hospital
Product
Solu-Cortef
Indication
Addison's Disease
Indication
Congenital Adrenal Hyperplasia
Product
Cortef