Adrenal InsufficiencyNCT00444119
Survey in Patients With Chronic Adrenal Insufficiency in Germany
An observational study of Adrenal Insufficiency and Addison's Disease, run by University of Wuerzburg at 2 sites in Germany.
Trial summary
The purpose of this survey is to assess patients with chronic primary or secondary adrenal failure regarding subjective health status, incidence and causes of adrenal crisis, hormone replacement regimens and concomitant endocrine or non endocrine disease. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Adrenal Insufficiency, Addison's Disease
- How many people
- Not given
- Where
- 2 sitesGermany
- Study dates
- May 2004to Apr 2005
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- age > 18 years
- chronic adrenal failure with disease duration > 12 months and hormone replacement therapy for cortisol deficiency
Who cannot join
- adrenal insufficiency due to adrenocortical carcinoma
- AI due to long-term pharmacological glucocorticoid treatment
- glucocortiocid doses above 7.5 mg prednisolone equivalent for other reasons than AI
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Dept of Medicine, Gastroenterology, Hepatology and Endocrinology, Charité Campus Mitte, Charité, University Medicine Berlin
Berlin, D-10117
University of Wuerzburg, Dept of Medicine - Endocrine and Diabetes unit
Würzburg, D-97080
About this study
The purpose of this survey is to assess patients with chronic primary or secondary adrenal failure regarding subjective health status, incidence and causes of adrenal crisis, hormone replacement regimens and concomitant endocrine or non endocrine disease.
- Conditions
- Adrenal Insufficiency, Addison's Disease
- Keywords
- adrenal insufficiency, subjective health status, quality of life, adrenal crisis, hormone replacement, DHEA
- Medical subject headings
- Adrenal Insufficiency, Addison Disease
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2007 (estimated)
- Study startMay 2004
- Study completionApr 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adrenal InsufficiencyStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Defined population
- Time perspective
- Other
Sponsor and investigators
- Lead sponsor
- University of Wuerzburg
- Sponsor type
- University, hospital or other
- Investigators
- Bruno Allolio, MD, Principal investigator, University of Wuerzburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00444119
- Sponsor's protocol ID
- Wü_NNRIS_45/04
- Status last verified
- Mar 2007
- First submitted
- 5 Mar 2007
- Last updated
- 7 Mar 2007
- Results posted
- No
Publications
Hahner S, Loeffler M, Fassnacht M, Weismann D, Koschker AC, Quinkler M, Decker O, Arlt W, Allolio B. Impaired subjective health status in 256 patients with adrenal insufficiency on standard therapy based on cross-sectional analysis. J Clin Endocrinol Metab. 2007 Oct;92(10):3912-22. doi: 10.1210/jc.2007-0685. Epub 2007 Aug 7.
PubMed 17684047
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survey in Patients With Chronic Adrenal Insufficiency in Germany
- ClinicalTrials.gov ID
- NCT00444119
- Acronym / sponsor ID
- Wü_NNRIS_45/04
- Conditions
- Adrenal Insufficiency, Addison's Disease
- Keywords
- adrenal insufficiency, subjective health status, quality of life, adrenal crisis, hormone replacement, DHEA
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- University of WuerzburgUniversity, hospital or other
- Study start
- May 2004
- Study completion
- Apr 2005
- First posted
- 7 Mar 2007 (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.
The purpose of this survey is to assess patients with chronic primary or secondary adrenal failure regarding subjective health status, incidence and causes of adrenal crisis, hormone replacement regimens and concomitant endocrine or non endocrine disease.
Study design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- age > 18 years
- chronic adrenal failure with disease duration > 12 months and hormone replacement therapy for cortisol deficiency
Key exclusion criteria (3 listed)
- adrenal insufficiency due to adrenocortical carcinoma
- AI due to long-term pharmacological glucocorticoid treatment
- glucocortiocid doses above 7.5 mg prednisolone equivalent for other reasons than AI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 7 Mar 2007.
- Derived from this study: PubMed 17684047Hahner S, Loeffler M, Fassnacht M, Weismann D, Koschker AC, Quinkler M, Decker O, Arlt W, Allolio B. Impaired subjective health status in 256 patients with adrenal insufficiency on standard therapy based on cross-sectional analysis. J Clin Endocrinol Metab. 2007 Oct;92(10):3912-22. doi: 10.1210/jc.2007-0685. Epub 2007 Aug 7.
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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.
Bruno Allolio, MD principal investigator
University of Wuerzburg
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adrenal Insufficiency and Addison's Disease, run by University of Wuerzburg at 2 sites in Germany.
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 2 inclusion and 3 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 7 Mar 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00444119, which also lists 1 linked publication.
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 7 Mar 2007.