Long Term Safety and Efficacy of Pasireotide s.c. in Patients With Cushing's Disease
NCT ID: NCT02310269
Last Updated: 2024-10-15
Study Results
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View full resultsBasic Information
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COMPLETED
152 participants
OBSERVATIONAL
2013-03-28
2023-07-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cohort 1/new use cohort
Subjects who initiated pasireotide s.c. at time of study entry (on or after the signing of the informed consent or acknowledging an equivalent document -for example, written information- as per country regulation).
Pasireotide
Cohort 2/prior use cohort
Subjects who initiated pasireotide s.c. prior to study entry.
Pasireotide
Interventions
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Pasireotide
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Male or female patients aged 18 years or older with a diagnosis of Cushing's disease for whom surgery has failed or for whom surgery is not an option
* Patients must be treated with pasireotide s.c. started either at the first visit for this study or prior to study entry
Exclusion Criteria
* Patients with adrenal Cushing's syndrome
* Patients with Pseudo Cushing's syndrome
18 Years
ALL
No
Sponsors
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RECORDATI GROUP
INDUSTRY
Responsible Party
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Principal Investigators
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Mario MALDONADO, MD
Role: STUDY_DIRECTOR
Recordati AG
Locations
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Praxis Michael Droste
Oldenburg, , Germany
Universitaetsklinikum Wuerzburg
Würzburg, , Germany
Rabin Medical Centre Belinson
Petah Tikva, , Israel
Universitaetsklinikum Freiburg
Freiburg im Breisgau, , Germany
Praxis Dr.med.Frank Ackermann
Halle, , Germany
Universitaetsklinikum Hamburg Eppendorf
Hamburg, , Germany
Universitaetsklinikum Leipzig AoR
Leipzig, , Germany
Universitaetsklinikum Magdeburg AoR
Magdeburg, , Germany
Universitaetsklinikum Muenchen LMU
München, , Germany
Medicover Muenchen Ost MVZ
München, , Germany
St Josephs Hospital and Medical Center
Phoenix, Arizona, United States
University of Southern California CSOM230B2410 - SC
Los Angeles, California, United States
Massachusetts General Hospital SC - SOM230B2410
Boston, Massachusetts, United States
Ohio State University SC - SOM230B2410
Columbus, Ohio, United States
Endocrinology Services
Bend, Oregon, United States
Allegheny Endocrinology Associates
Pittsburgh, Pennsylvania, United States
Swedish Medical Center Dept.ofSeattle Neuroscience(2)
Seattle, Washington, United States
Centre de recherche du CHUM CRCHUM
Montreal, Quebec, Canada
CHUL Centre de recherche du CHU
Québec, Quebec, Canada
CHUS - Hopital Fleurimont
Sherbrooke, Quebec, Canada
Centro Medico Imbanaco de Cali
Cali, , Colombia
CHU Amiens Picardie Site Nord
Amiens, , France
HCL-Groupe Hospitalier Est
Bron, , France
Recordati Investigative Site
Lille, , France
AP-HM - Hopital de la Conception
Marseille, , France
Hopital Lapeyronie
Montpellier, , France
Hopital Cochin
Paris, , France
Hopital Robert Debre
Reims, , France
HIA Begin
Saint-Mandé, , France
CHU de Saint Etienne
Saint-Priest-en-Jarez, , France
Universitaetsklinikum Aachen
Aachen, , Germany
Universitaetsmedizin Charite
Berlin, , Germany
Univ.-Klinikum Düsseldorf
Düsseldorf, , Germany
Universitaetsklinikum Erlangen Nuernberg
Erlangen, , Germany
Universitaetsklinikum Essen
Essen, , Germany
Tel Aviv Sourasky Medical Centre Ichilov
Tel Aviv, , Israel
AOU Osp Riuniti Umberto I GM Lancisi G Salesi Univ Studi
Ancona, AN, Italy
Az.Ospe.Universitaria Policlinico G. Martino Univ.di Messina
Messina, ME, Italy
Fond IRCCS Ca Granda Ospedale Maggiore Policlinico
Milan, MI, Italy
Stab.Osp.S.Luca P.O. S.Luca-S.Michele-Ist.Auxol. Italiano
Milan, MI, Italy
Az Osp Univ Policlinico P Giaccone Universita Studi Palermo
Palermo, PA, Italy
Azienda Ospedaliera di Padova Universita degli Studi
Padua, PD, Italy
Az Ospedaliero Universitaria Pisana Pres Osped di Cisanello
Pisa, PI, Italy
P O Molinette AO Citta della Salute e della Scienza Torino
Torino, TO, Italy
O Universitaria Policlinico Federico II Univ Studi Fed II
Napoli, , Italy
Hotel Dieu de France Hospital
El Achrafiyé, , Lebanon
Maastricht Universitair Medisch Centrum
Maastricht, AZ, Netherlands
Radboudumc
Nijmegen, , Netherlands
Spitalul Clinic Judetean de Urgenta Brasov
Brasov, , Romania
Institutul de Endocrinologie "I. C. Parhon", Bucuresti
Bucharest, , Romania
Spitalul Clinic Jude Emergency Clinical County Hospital Cluj
Cluj-Napoca, , Romania
County Hospital Tg. Mures
Târgu Mureş, , Romania
Derriford Hospital
Plymouth, , United Kingdom
Southampton General Hospital
Southampton, , United Kingdom
Countries
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References
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Manetti L, Deutschbein T, Schopohl J, Yuen KCJ, Roughton M, Kriemler-Krahn U, Tauchmanova L, Maamari R, Giordano C. Long-term safety and efficacy of subcutaneous pasireotide in patients with Cushing's disease: interim results from a long-term real-world evidence study. Pituitary. 2019 Oct;22(5):542-551. doi: 10.1007/s11102-019-00984-6.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CSOM230B2410
Identifier Type: -
Identifier Source: org_study_id
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