NCT01063569

Glucocorticoid Treatment in Addison's Disease

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Haukeland University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Addison's disease is a rare condition which in most cases is caused by autoimmune destruction of the adrenals, leading to deficiency of cortisol, aldosterone and adrenal androgens. Unrecognized the disease is life threatening, but with proper treatment patients can live near normal lives. The conventional glucocorticoid replacement therapy renders the cortisol levels unphysiological, which may cause symptoms and long-term complications. Glucocorticoid replacement therapy is technically feasible by continuous subcutaneous hydrocortisone infusion (CSHI), and can mimic the normal diurnal cortisol rhythm. This study aims to further evaluate CSHI treatment in terms of metabolic effects, effects on health-related quality-of-life and sleep in an 8 months randomised open label clinical trial with crossover design.

Conditions

• Addison's Disease

Interventions

Type	Name	Description
DRUG	Solu-Cortef (hydrocortisone)	Continuous Subcutaneous Hydrocortisone infusion via insulin pump. Doses adjusted to body surface area.
DRUG	Cortef (hydrocortisone)	Oral treatment 3 times a day. Weight adjusted doses.

Timeline

• Start date: 2010-02-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2010-02-05
• Last updated: 2013-03-20

Locations

3 sites across 2 countries: Norway, Sweden