Glucocorticoid Treatment in Addison's Disease

Addison's Disease Clinical Trial

Official title:

Glucocorticoid Treatment in Addison's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01063569
• Other study ID #: 3.2007.2343
• Secondary ID: 2009-010917-61
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: January 26, 2010
• Last updated: March 19, 2013
• Start date: February 2010
• Est. completion date: December 2012

Study information

• Verified date: March 2013
• Source: Haukeland University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Medicines AgencyNorway: Regional Committee for Medical and Health Research Ethics, Western NorwayNorway: Norwegian Social Science Data Services
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patients with verified Addison's disease on stable treatment.

Exclusion Criteria:

• Insulin treated Diabetes Mellitus, cardiovascular disease,malignant disease, pregnancy.

• Treatment with glucocorticoids or drugs that interfere with cortisol metabolism (antiepileptics, rifampicin, St. John's wart).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Addison Disease
• Addison's Disease

Intervention

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

Locations

Country	Name	City	State
Norway	Haukeland University Hospital	Bergen
Sweden	Karolinska Institutet	Stockholm
Sweden	Uppsala University	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Haukeland University Hospital

Countries where clinical trial is conducted

Norway,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morning (08-09) plasma ACTH		Time 0, months 2, 3, 5, 7 and 8	No
Secondary	Health-Related Quality of Life; evaluated by SF-36 vitality scores and AddiQoL scores		At time 0 and months 2,3,5,7 and 8	No
Secondary	Sleep; evaluated by Pittsburgh Sleep Quality Index (PSQI), and 7-days' Actigraph registration combined with self-reported sleep diary		PSQI: 0 and months 2,3,5,7 and 8; Actigraph/sleep diary: months 2 and 7	No
Secondary	24h cortisol profiles in serum and saliva		months 2 and 7	No
Secondary	S-glucose, 24 h profile		months 2 and 7	No
Secondary	Insulin sensitivity assessed by euglycemic clamp		Months 2 and 7	No