Addison's DiseasePhase 2/3NCT01063569
Glucocorticoid Treatment in Addison's Disease
A Phase 2/3 study testing Solu-Cortef (hydrocortisone) and Cortef (hydrocortisone) in people with Addison's Disease, run by Haukeland University Hospital at 3 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Addison's Disease
- What is being tested?
- Solu-Cortef (hydrocortisone) and Cortef (hydrocortisone)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Feb 2010to Dec 2012
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with verified Addison's disease on stable treatment.
Who cannot join
- 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).
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
About this study
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
- Being tested
- Solu-Cortef (hydrocortisone), Cortef (hydrocortisone)
- Keywords
- Addison's disease, Glucocorticoid treatment, Continuous subcutaneous hydrocortisone infusion, CSHI, Quality of Life, Sleep
- Medical subject headings
- Addison Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Solu-Cortef (hydrocortisone)Drug
Also called Solu-Cortef
Continuous Subcutaneous Hydrocortisone infusion via insulin pump. Doses adjusted to body surface area.
Cortef (hydrocortisone)Drug
Also called Cortef 5 mg
Oral treatment 3 times a day. Weight adjusted doses.
| Study group | Role | What they receive |
|---|---|---|
| Oral hydrocortisone | Active comparator | Not described Receives: Drug: Cortef (hydrocortisone) |
| Continous subcutaneous hydrocortisone infusion | Experimental | Not described Receives: Drug: Solu-Cortef (hydrocortisone) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morning (08-09) plasma ACTH
Measured: Time 0, months 2, 3, 5, 7 and 8
Secondary outcomes (5)
Health-Related Quality of Life; evaluated by SF-36 vitality scores and AddiQoL scores
Measured: At time 0 and months 2,3,5,7 and 8
Sleep; evaluated by Pittsburgh Sleep Quality Index (PSQI), and 7-days' Actigraph registration combined with self-reported sleep diary
Measured: PSQI: 0 and months 2,3,5,7 and 8; Actigraph/sleep diary: months 2 and 7
24h cortisol profiles in serum and saliva
Measured: months 2 and 7
S-glucose, 24 h profile
Measured: months 2 and 7
Insulin sensitivity assessed by euglycemic clamp
Measured: Months 2 and 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Addison's DiseaseStudies of the same condition, open and under way.
- More trials run by Haukeland University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kristian Løvås, MD,PhD, Principal investigator, Haukeland University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01063569
- Sponsor's protocol ID
- 3.2007.2343
- Other IDs
- 2009-010917-61, 2009
- Status last verified
- Mar 2013
- First submitted
- 26 Jan 2010
- Last updated
- 20 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glucocorticoid Treatment in Addison's Disease
- ClinicalTrials.gov ID
- NCT01063569
- Acronym / sponsor ID
- 3.2007.2343
- Conditions
- Addison's Disease
- Keywords
- Addison's disease, Glucocorticoid treatment, Continuous subcutaneous hydrocortisone infusion, CSHI, Quality of Life, Sleep
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 5 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral hydrocortisone | Active comparator | Drug: Cortef (hydrocortisone) |
| Continous subcutaneous hydrocortisone infusion | Experimental | Drug: Solu-Cortef (hydrocortisone) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with verified Addison's disease on stable treatment.
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Solu-Cortef (hydrocortisone)Also: Solu-CortefContinuous Subcutaneous Hydrocortisone infusion via insulin pump. Doses adjusted to body surface area. | Drug | Continous subcutaneous hydrocortisone infusion |
| Cortef (hydrocortisone)Also: Cortef 5 mgOral treatment 3 times a day. Weight adjusted doses. | Drug | Oral hydrocortisone |
Primary outcome
Morning (08-09) plasma ACTH
Time frame: Time 0, months 2, 3, 5, 7 and 8
5 secondary outcomes
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
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
24h cortisol profiles in serum and saliva
Time frame: months 2 and 7
S-glucose, 24 h profile
Time frame: months 2 and 7
Insulin sensitivity assessed by euglycemic clamp
Time frame: Months 2 and 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristian Løvås, MD,PhD principal investigator
Haukeland University Hospital
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Solu-Cortef (hydrocortisone) and Cortef (hydrocortisone) in people with Addison's Disease, run by Haukeland University Hospital at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sweden, Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morning (08-09) plasma ACTH (time frame: Time 0, months 2, 3, 5, 7 and 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2013.