Status:
COMPLETED
Dual RElease Hydrocortisone Versus conventionAl Glucocorticoid replaceMent Therapy in Hypocortisolism (DREAM)
Lead Sponsor:
University of Roma La Sapienza
Conditions:
Primary Adrenal Insufficiency
Secondary Adrenal Insufficiency
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
This is a randomized, controlled, open, three-armed, multi-centre study designed to compare the effects of dual-release hydrocortisone preparations versus conventional glucocorticoid therapy on anthro...
Detailed Description
Hypocortisolism is a disease with more than 80% 1-year mortality before the availability of synthetic glucocorticoids. Current replacement therapy has improved this dramatically, but recent data sugge...
Eligibility Criteria
Inclusion
- Previously diagnosed (e.g. more than 6 months ago) primary or secondary adrenal insufficiency with a stable daily glucocorticoid substitution dose for at least 3 months prior to study entry
- Signed informed consent to participate in the study
Exclusion
- acute primary or secondary adrenal insufficiency
- clinical or laboratory signs of significant cerebral, cardiovascular, respiratory, hepatobiliary, pancreatic disease
- clinically significant renal dysfunction
- any medication with agents which could interfere with glucocorticoid kinetics
Key Trial Info
Start Date :
March 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2016
Estimated Enrollment :
89 Patients enrolled
Trial Details
Trial ID
NCT02277587
Start Date
March 1 2014
End Date
June 1 2016
Last Update
April 25 2019
Active Locations (1)
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1
Department of Experimental Medicine
Rome, Italy, 00161