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A European Post-Authorisation Observational Study (Registry) of Patients With Chronic Adrenal Insufficiency (AI)

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ClinicalTrials.gov Identifier: NCT01661387
Recruitment Status : Recruiting
First Posted : August 9, 2012
Last Update Posted : January 27, 2017
Sponsor:
Information provided by (Responsible Party):
Shire

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
As a post-approval requirement of the European Medicines Agency, this European patient post authorization safety study is an observational study being conducted to monitor the safety of long-term treatment with Plenadren and other glucocorticoid replacement therapies in routine clinical practice in patients with chronic adrenal insufficiency (primary or secondary).

Condition or disease
Chronic Adrenal Insufficiency

Study Design
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Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A European, Multi-Centre, Multi-Country, Post-Authorisation, Observational Study (Registry) of Patients With Chronic Adrenal Insufficiency (AI)
Study Start Date : August 2012
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
Plenadren
Modified release hydrocortisone
Other Glucocorticoid Replacement Therapy


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of intercurrent illness [ Time Frame: 5 years ]
    Monitor the safety of long-term treatment with PLENADREN and other glucocorticoid replacement therapies in patients with chronic AI

  2. Incidence of adrenal crisis [ Time Frame: 5 years ]
    Monitor the safety of long-term treatment with PLENADREN and other glucocorticoid replacement therapies in patients with chronic AI

  3. Incidence of serious adverse events [ Time Frame: 5 years ]
    Monitor the safety of long-term treatment with PLENADREN and other glucocorticoid replacement therapies in patients with chronic AI


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with chronic adrenal insufficiency (primary or secondary) who are receiving Plenadren or other glucocorticoid replacement therapies at endocrinology centres in certain European countries as part of their routine clinical care. Approximately 20 sites are planned for enrollment.
Criteria

Inclusion Criteria:

  • Diagnosis of chronic adrenal insufficiency
  • Written informed consent/assent in compliance with applicable country-specific and local regulations

Exclusion Criteria:

  • Participation in an interventional clinical trial
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT01661387


Contacts
Contact: Shire Contact protocol0918400@shire.com
Contact: Shire Transparency clinicaltransparency@shire.com

Locations
Germany
Charité - Universitätsmedizin Berlin Recruiting
Berlin, Germany, 10117
Contact: Kathrin Zopf    0049 30450 51 4019    Kathrin.Zopf@charite.de   
Principal Investigator: Tina Kienitz         
Endokrinologiepraxis am Stuttgarter Platz Recruiting
Berlin, Germany, 10627
Contact: Kathrin Zopf    0049 302132004    praxis@endokrinologie-charlottenburg.de   
Principal Investigator: Marcus Quinkler         
Friedrich Alexander Universitat Erlangen Nurnberg Recruiting
Erlangen, Germany, 91054
Contact: Monika Lindenberg    0049 9131853-5223    monika.lindenberg@uk-erlangen.de   
Principal Investigator: Flavius Zoicas         
Universitätsklinikum Frankfurt Recruiting
Frankfurt, Germany, 60590
Contact: Maria Sandler    0049 069 6301 7818    maria.sandler@kgu.de   
Principal Investigator: Klaus Badenhoop         
LMU Klinikum der Universität München Recruiting
Munchen, Germany, 80336
Contact: Susanne Schmid    0049 89 5160 5 2414    Susanne_Schmid@med.uni-muenchen.de   
Principal Investigator: Felix Beuschlein         
Max Planck Institute für Psychiatrie Recruiting
Munchen, Germany, 80804
Contact: E Stettberger    0049 89 3062 2593    stettberger@mpipsukl.mpg.de   
Principal Investigator: Gunter Stalla         
Medicover Oldenburg MVZ Recruiting
Oldenburg, Germany, 26122
Contact: Smadar Pahl    00 49 441 218 460    s.pahl@endokrin-ol.de   
Principal Investigator: Michael Droste         
Endokrinologiezentrum Ulm Praxis Not yet recruiting
Ulm, Germany, 89073
Contact: Gwendolin Etzrodt-Walter       info@endokrinologie-ulm.de   
Principal Investigator: Gwendolin Etzrodt-Walter         
Universitätsklinikum Würzburg Recruiting
Wuerzburg, Germany, 97080
Contact: Martina Zink    0049 93120139968    zink_m@klinik.uni-wuerzburg.de   
Principal Investigator: Stephanie Hahner         
Italy
Università degli Studi Federico II Not yet recruiting
Napoli, Italy, 80131
Principal Investigator: Rosario Pivonello         
Policlinico Umberto I Not yet recruiting
Rome, Italy, 00161
Principal Investigator: Andrea Isidori         
Policlinico Universitario Agostino Gemelli Not yet recruiting
Rome, Italy, 00168
Contact: Salvatore Corsello       corsello.sm@mclink.it   
Principal Investigator: Salvatore Corsello         
Netherlands
Universitair Medisch Centrum Groningen Recruiting
Groningen, Netherlands, 9700
Contact: Mariska Groeneveld    0031503612987    m.a.groeneveld@umcg.nl   
Principal Investigator: Andre van Beek         
Erasmus MC Recruiting
Rotterdam, Netherlands, 3015
Contact: Sjaan Poldermans       b.poldermans@erasmusmc.nl   
Principal Investigator: Richard Feelders         
Universitair Medisch Centrum Utrecht Recruiting
Utrecht, Netherlands, 3584
Contact: Marjolijn Peltenburg       mpeltenb@umcutrecht.nl   
Principal Investigator: Pierre Zelissen         
Sweden
Sahlgrenska Universitetssjukhuset Recruiting
Gothenborg, Sweden, 413 45
Contact: Kristina Cid Käll    004631471249    kristina.cid.kall@vgregion.se   
Principal Investigator: Anna Nilsson         
Universitetssjukhuset i Linköping Recruiting
Linkoping, Sweden, 58185
Contact: Sofia Sjoberg    0046703822234    sofia.k.sjoberg@regionostergotland.se   
Principal Investigator: Bertil Ekman         
United Kingdom
Queen Elizabeth Hospital Recruiting
Birmingham, United Kingdom, B12 2TT
Contact: Niki Karavitaki    0044 1214 158 715    niki.karavitaki@uhb.nhs.uk   
Principal Investigator: Nikki Karavitaki         
St James University Hospital Recruiting
Leeds, United Kingdom, LS9 7TF
Contact: Julie Lynch    0044113 20 64660    julie.lynch5@nhs.net   
Principal Investigator: Robert Murray         
Barts and The London NHS Trust Recruiting
London, United Kingdom, EC1A 7BE
Contact: Jane Pheby    0044 20 7882 5660    j.m.pheby@qmul.ac.uk   
Principal Investigator: William Drake         
Royal Free Hospital Completed
London, United Kingdom, NW3 2QG
Christie Hospital Recruiting
Manchester, United Kingdom, M20 4BX
Contact: Victoria Hutchinson    0044 (0)161 446 8132    Victoria.Hutchinson@christie.nhs.uk   
Principal Investigator: Peter Trainer         
Royal Victoria Infirmary Recruiting
Newcastle, United Kingdom, NE1 4LP
Contact: Margaret Morris    0044 0191 282 0462    margaret.morris@nuth.nhs.uk   
Principal Investigator: Simon Pearce         
Churchill Hospital Recruiting
Oxford, United Kingdom, OX3 7LE
Contact: Violet Fazal-Sanderson    00441865 857266    violet.sanderson@ouh.nhs.uk   
Principal Investigator: Ashley Grossman         
Sponsors and Collaborators
Shire
Investigators
Study Director: Shire Physician Shire
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01661387     History of Changes
Other Study ID Numbers: Protocol 0918-400
First Posted: August 9, 2012    Key Record Dates
Last Update Posted: January 27, 2017
Last Verified: January 2017

Keywords provided by Shire:
Adrenal insufficiency
DuoCort
Congenital adrenal hyperplasia (CAH)
Modified release
Hydrocortisone

Additional relevant MeSH terms:
Adrenal Insufficiency
Adrenal Gland Diseases
Endocrine System Diseases
Hydrocortisone
Epinephrine
Racepinephrine
Epinephryl borate
Anti-Inflammatory Agents
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
 Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents