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