Survey in Patients With Chronic Adrenal Insufficiency in... | NCT00444119

Studies
Survey in Patients With Chronic Adrenal Insufficiency in Germany

NCT00444119

Sponsor

University of Wuerzburg

Status

Completed

Last Update Posted

Mar 7, 2007Estimated

Enrollment

Not provided

Phase

Not provided

Conditions

Adrenal Insufficiency
Addison's Disease

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2004

Primary Completion Date

Not provided

Completion Date

Apr 2005

First Submitted Date

Mar 5, 2007

First Submission Date that Met QC Criteria

Mar 5, 2007

First Posted Date

Mar 7, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 5, 2007

Last Update Posted Date

Mar 7, 2007Estimated

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age > 18 years
chronic adrenal failure with disease duration > 12 months and hormone replacement therapy for cortisol deficiency

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bruno Allolio, MD	University of Wuerzburg	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dept of Medicine, Gastroenterology, Hepatology and Endocrinology, Charité Campus Mitte, Charité, University Medicine Berlin		Berlin		D-10117	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17684047	Derived	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.

ID	Term
D000309	Adrenal Insufficiency
D000224	Addison Disease

ID	Term
D000307	Adrenal Gland Diseases
D004700	Endocrine System Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases