Glucocorticoid Treatment in Addison's Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2012-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Addison's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Oral hydrocortisone

Group Type ACTIVE_COMPARATOR

Cortef (hydrocortisone)

Intervention Type DRUG

Oral treatment 3 times a day. Weight adjusted doses.

Continous subcutaneous hydrocortisone infusion

Group Type EXPERIMENTAL

Solu-Cortef (hydrocortisone)

Intervention Type DRUG

Continuous Subcutaneous Hydrocortisone infusion via insulin pump. Doses adjusted to body surface area.

Interventions

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Solu-Cortef (hydrocortisone)

Continuous Subcutaneous Hydrocortisone infusion via insulin pump. Doses adjusted to body surface area.

Intervention Type DRUG

Cortef (hydrocortisone)

Oral treatment 3 times a day. Weight adjusted doses.

Intervention Type DRUG

Other Intervention Names

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Solu-Cortef Cortef 5 mg

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No