Primary adrenal insufficiency MedDRA version: 14.1 Level: PT Classification code 10052381 Term: Primary adrenal insufficiency System Organ Class: 10014698 - Endocrine disorders
Conditions
Sponsors
DuoCort Pharma AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Males and females; age 18 years and above. - Previously diagnosed (e.g. more than 6 months ago) primay adrenal insufficiency with a stable daily glucocorticoid substitution dose of at least 3 months prior to study entry. - An oral hydrosortisone substitution therapy dose of 15-40 mg total dialy dose. - Signed informed consent to participate in the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Clinical or laboratory signs of sigificant cerebral, cardiovascular, respiratory, hepatiobiliary, pancreatic disease, which in the investigators judgment may interfere with the study assessment or completion of the study. - Clinically significant renal dysfunction with a serum creatinine above 150 mmol/L. - Any additional underlying disease that may need regular or periodic pharmacological treatment with glucocorticoids. - Administration of other investigational drugs within eight weeks preceding the preentry examination. - Alcohol/drug abuse or any condition associated with poor patient compliance, including expected non-cooperation, as judged by investigator. - Regular DHEA medication for the past 4 weeks. - Deranged mineralcorticoid status as determined by clinical (hypotension, ortostatic hypotension) and biochemical status (serum sodium and potassium level).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety, tolerability and efficacy in long term treatment of once-daily oral modified-release hydrocortisone in patients with chronic primary adrenal insufficiency.;Secondary Objective: To assess the safety of using the novel modified release formulation as "rescue therapy" during minor intercurrent illnessess in patients with primary adrenal insufficiency. ;Primary end point(s): To evaluate the safety, tolerability and efficacy of dosing of one-daily oral modified release hydrocortisone in patiens with adrenal insufficiency. | — |
Countries
Sweden
Contacts
Public ContactAssociateDirector,ClinicalOperation
DuoCort Pharma AB
Outcome results
None listed