A study of markers of glucocorticoid effects

Phase 1

• Conditions: Adrenal insufficiency e.g. Addison´s disease; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2016-004078-16-SE
• Lead Sponsor: Sahlgrenska University Hospital, Gothenburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-05-05
• Last Update Posted: 2 March 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

•Males and females at ages 20-65 years
•Previously diagnosed (e.g. more than 12 months ago) with primary adrenal insufficiency due to autoimmune adrenalitis, i.e. Addison´s disease
•A stable daily glucocorticoid replacement dose for at least 3 months prior to study entry
•An oral glucocorticoid replacement dose of 15-30 mg Hydrocortisone total daily dose
•If needed, a stable fludrocortisone replacement dose for at least 3 months prior to study entry
•Body mass index (BMI) of 20-35 kg/m2
•Ability to comply to the protocol procedures and having 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 30
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Clinical or laboratory signs of significant cerebral, cardiovascular, respiratory, hepaticobiliary/ pancreatic disease which in the investigators judgement may interfere with the study assessment of completion of the study
•Clinically significant renal dysfunction with a serum creatinine above 150 mmol/L
•Pregnant or lactating women
•Diabetes Mellitus
•Systemic infections
•Regular dehydroepiandrosterone (DHEA) medication for the past 4 weeks
•Any medication with agents which in the investigators judgement might interfere with the study drugs kinetics, including therapies affecting gastro intestinal emptying or motility
•Alcohol/drug abuse or any other condition associated with poor patient compliance, including expected non-cooperation, as judged by the investigator
•Hypersensitivity to the active substance or any excipients used in the study drug of choice
•Any additional underlying disease that may need regular or periodic pharmacological treatment with glucocorticoids during the trail, such as asthma, skin- or eye conditions treated with inhaled or topical glucocorticoids
•Any additional underlying condition that needs treatment with intramuscular or intra-articular steroid injections during the trial

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified