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Glucocorticoid Treatment in Addison's Disease

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ClinicalTrials.gov Identifier: NCT01063569
Recruitment Status : Completed
First Posted : February 5, 2010
Last Update Posted : March 20, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.


Condition or disease Intervention/treatment Phase
Addison's Disease Drug: Solu-Cortef (hydrocortisone) Drug: Cortef (hydrocortisone) Phase 2 Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Glucocorticoid Treatment in Addison's Disease
Study Start Date : February 2010
Primary Completion Date : December 2012
Study Completion Date : December 2012


Arms and Interventions

Arm Intervention/treatment
Active Comparator: Oral hydrocortisone Drug: Cortef (hydrocortisone)
Oral treatment 3 times a day. Weight adjusted doses.
Other Name: Cortef 5 mg
Experimental: Continous subcutaneous hydrocortisone infusion Drug: Solu-Cortef (hydrocortisone)
Continuous Subcutaneous Hydrocortisone infusion via insulin pump. Doses adjusted to body surface area.
Other Name: Solu-Cortef


Outcome Measures

Primary Outcome Measures :
  1. Morning (08-09) plasma ACTH [ Time Frame: Time 0, months 2, 3, 5, 7 and 8 ]

Secondary Outcome Measures :
  1. Health-Related Quality of Life; evaluated by SF-36 vitality scores and AddiQoL scores [ Time Frame: At time 0 and months 2,3,5,7 and 8 ]
  2. Sleep; evaluated by Pittsburgh Sleep Quality Index (PSQI), and 7-days' Actigraph registration combined with self-reported sleep diary [ Time Frame: PSQI: 0 and months 2,3,5,7 and 8; Actigraph/sleep diary: months 2 and 7 ]
  3. 24h cortisol profiles in serum and saliva [ Time Frame: months 2 and 7 ]
  4. S-glucose, 24 h profile [ Time Frame: months 2 and 7 ]
  5. Insulin sensitivity assessed by euglycemic clamp [ Time Frame: Months 2 and 7 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01063569


Locations
Norway
Haukeland University Hospital
Bergen, Norway, 5021
Sweden
Karolinska Institutet
Stockholm, Sweden
Uppsala University
Uppsala, Sweden
Sponsors and Collaborators
Haukeland University Hospital
Investigators
Principal Investigator: Kristian Løvås, MD,PhD Haukeland University Hospital
More Information

Responsible Party: Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT01063569     History of Changes
Other Study ID Numbers: 3.2007.2343
2009-010917-61 ( EudraCT Number )
First Posted: February 5, 2010    Key Record Dates
Last Update Posted: March 20, 2013
Last Verified: March 2013

Keywords provided by Haukeland University Hospital:
Addison's disease
Glucocorticoid treatment
Continuous subcutaneous hydrocortisone infusion
CSHI
Quality of Life
Sleep

Additional relevant MeSH terms:
Addison Disease
Adrenal Insufficiency
Adrenal Gland Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Cortisol succinate
Hydrocortisone
Glucocorticoids
Anti-Inflammatory Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs