Overview

Modified-release Compared to Conventional Hydrocortisone on Diurnal Fatigue in Secondary Hypoadrenalism

Status:
Unknown status
Trial end date:
2017-12-01
Target enrollment:
0
Participant gender:
All
Summary
Despite optimized hydrocortisone replacement regimes, many patients with adrenal insufficiency (AI) suffer from impaired quality of life (QoL). Characteristically, patients report high fatigue levels at certain times during the day. A modified-release hydrocortisone has been shown to improve QoL, particularly fatigue, in patients with primary AI. However, it is unknown, if the same effect can be observed in patients with secondary AI. Further, no studies have evaluated the effect, taking into account the diurnal variation of fatigue. A novel survey method termed Ecological Momentary Assessments (EMA) has the potential to provide reliable measurements of diurnal variations in patient-reported outcomes, such as fatigue. We will compare the effect of modified-release compared to conventional hydrocortisone on fatigue in patients with secondary AI due to pituitary disease, and hereby assess the feasibility of EMA as outcome in future large-scale randomised clinical trials (RCTs).
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Ulla Feldt-Rasmussen
Treatments:
Cortisol succinate
Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Criteria
Inclusion Criteria:

- Diagnosed with adrenal insufficiency due to hypopituitarism

- In steady twice or thrice daily (10-40 mg) hydrocortisone replacement treatment

- Written informed consent

- For women: Use of reliable methods of contraception in clinical trials in accordance
with the definition by the Danish Health and Medicines Authority; intrauterine devices
or hormonal methods (oral contraceptives, contraceptive implants, transdermal patches,
hormonal vaginal devices or injections with prolonged release).

Exclusion Criteria:

- Pregnancy

- Breast feeding

- Acromegaly

- Cushing's Disease

- Diabetes Mellitus

- Other major confounding disease

- Known or expected hypersensitivity to any of the excipients

- Lack of compliance (attendance and medication)