Overview

Once-daily Oral Modified Release Hydrocortisone in Patients With Adrenal Insufficiency

Status:
Completed
Trial end date:
2009-01-28
Target enrollment:
0
Participant gender:
All
Summary
This is a randomised, controlled, open, two-armed, two-period cross-over, multi-centre phase II/III study to assess the safety, tolerability and pharmacokinetics of once-daily oral modified-release hydrocortisone in comparison to conventional thrice-daily oral hydrocortisone tablets in patients with adrenal insufficiency
Phase:
Phase 2/Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Shire
Treatments:
Cortisol succinate
Epinephrine
Epinephryl borate
Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Racepinephrine
Criteria
Inclusion Criteria:

- Previously diagnosed (e.g. more than 6 months ago) primary 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 Criteria:

- Clinical or laboratory signs of significant cerebral, cardiovascular, respiratory,
Hepatobiliary, pancreatic disease

- Clinically significant renal dysfunction

- Clinical or laboratory signs of significant gastrointestinal emptying or motility
disease

- Any medication with agents which could interfere with hydrocortisone kinetics

- Pregnant or lactating women

- Regular dehydroepiandrosterone (DHEA) medication for the past 4 weeks

- Oral oestrogen medication for the past 4 weeks

- Deranged mineralocorticoid status