A Study of Efficacy and Safety of Mongersen (GED-0301) for the Treatment of Adult and Adolescent Subjects With Active Crohn's Disease
NCT ID: NCT02974322
Last Updated: 2017-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE3
INTERVENTIONAL
2017-12-01
2018-12-24
Brief Summary
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All patients who complete the study will have the option to enter a long term active treatment study.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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GED-0301 1 x 160 mg once daily
GED-0301 1 x 160 mg tablet once daily (QD)
GED-0301
GED-0301
GED-0301 - 4 x 40 mg once daily
GED-0301 4 x 40 mg tablets once daily (QD)
GED-0301
GED-0301
Placebo once daily
Placebo once daily (QD)
Placebo
Placebo
Interventions
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GED-0301
GED-0301
Placebo
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Male or female ≥ 12 years
* Subject is able to swallow the IP tablets
* Active Crohn's disease (CD) disease as determined by the Crohn's Disease Activity Index (CDAI) score and the Simple Endoscopic Score for Crohn's Disease (SES-CD)
* Must meet a determined average minimum number of daily stools or rating of abdominal pain over a 7day period
* Subject must have failed or experienced intolerance to at least one of the following: budesonide; systemic corticosteroids; immunosuppressants (eg, azathiopurine, 6-mercaptopurine, or methotrexate); or biologics for the treatment of CD (ie, infliximab, adalimumab, certolizumab, or vedolizumab).
Exclusion Criteria
* Local manifestations of Crohn's Disease (CD) such as abscesses, short bowel syndrome; or other disease complications for which surgery might be indicated or could confound the evaluation of efficacy
* Subject has strictures with prestenotic dilatation, requiring procedural intervention, or with obstructive symptoms. In addition, subjects with colonic strictures that are not passable with an age-appropriate colonoscope, or strictures in the ileum or ileocecal valve that are fibrotic in nature, will be excluded
* Intestinal resection within 6 months or any intra-abdominal surgery within 3 months prior to the Screening Visit
* Ileostomy or a colostomy
* Subject has a history of any clinically significant medical condition that, in the investigator's opinion, would prevent the subject from participating in the study
* Adolescents with delayed growth or pubertal development who are on corticosteroids at baseline and who should not continue treatment with the same dose of corticosteroids until the Week 12 visit.
12 Years
ALL
No
Sponsors
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Celgene
INDUSTRY
Responsible Party
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Principal Investigators
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Denesh Chitkara, MD
Role: STUDY_DIRECTOR
Celgene Corporation
Locations
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Dcr-Pi Pc
Litchfield Park, Arizona, United States
Arizona Digestive Health
Mesa, Arizona, United States
Arizona Digestive Health
Phoenix, Arizona, United States
Phoenix Childrens Hospital
Phoenix, Arizona, United States
Mayo Clinic Arizona
Scottsdale, Arizona, United States
Arizona Digestive Health
Sun City, Arizona, United States
Gastroenterology Associates PA
Little Rock, Arkansas, United States
Valley View Internal Medicine
Garden Grove, California, United States
High Desert Gastroenterology, Inc.
Lancaster, California, United States
University of Southern California Medical Center
Los Angeles, California, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
Facey Medical Foundation
Mission Hills, California, United States
Medical Associates Research Group Inc.
San Diego, California, United States
University of California at San Francisco (PARENT)
San Francisco, California, United States
HCP Clinical Research LLC
Torrance, California, United States
Ventura Clinical Trials
Ventura, California, United States
University Of Colorado
Aurora, Colorado, United States
Innovative Clinical Research
Lafayette, Colorado, United States
Connecticut Gastroenterology Institute
Bristol, Connecticut, United States
Medical Research Center of Connecticut LLC
Hamden, Connecticut, United States
Connecticut GI PC Research Division
Hartford, Connecticut, United States
Yale University
New Haven, Connecticut, United States
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States
Florida Center for Gastroenterology
Largo, Florida, United States
University of Miami
Miami, Florida, United States
Advance Medical Research Center
Miami, Florida, United States
Cordova Research Institute
Miami, Florida, United States
Sanitas Research
Miami, Florida, United States
Galiz Research LLC
Miami Springs, Florida, United States
Gastroenterology Group of Naples
Naples, Florida, United States
GCRM
Orlando, Florida, United States
Center For Digestive Health
Orlando, Florida, United States
Advanced Medical Research Center
Port Orange, Florida, United States
East Coast Institute for Research LLC
Saint Augustine, Florida, United States
Clinical Research of West Florida, Inc.
Tampa, Florida, United States
Cleveland Clinic Florida Weston
Weston, Florida, United States
Shafran Gastroenterology Center
Winter Park, Florida, United States
Georgia Regents University
Augusta, Georgia, United States
Columbus Regional Research Institute
Columbus, Georgia, United States
Atlanta Gastroenterology Specialists PC
Suwanee, Georgia, United States
Northwestern University-Feinberg School of Medicine
Chicago, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
Northshore University Healthsystem Research Institute
Evanston, Illinois, United States
Indiana University School of Medicine
Indianapolis, Indiana, United States
Iowa Digestive Disease Center
Clive, Iowa, United States
Health Science Research Center, LLC
Pratt, Kansas, United States
Heartland Research Associates LLC
Wichita, Kansas, United States
Via Christi Research a division of Via Christi Hospitals Wichita Inc
Wichita, Kansas, United States
Graves Gilbert Clinic
Bowling Green, Kentucky, United States
University of Kentucky Medical Center
Lexington, Kentucky, United States
University of Louisville
Louisville, Kentucky, United States
Gastroenterology Associates, LLC
Baton Rouge, Louisiana, United States
Clinical Trials of SW Louisiana LLC
Lake Charles, Louisiana, United States
Louisiana Research Center LLC
Shreveport, Louisiana, United States
University of Maryland Medical Group
Baltimore, Maryland, United States
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States
Charm City Research Group
Towson, Maryland, United States
Boston Medical Center
Boston, Massachusetts, United States
Lahey Clinic Inc. - PARENT ACCOUNT
Burlington, Massachusetts, United States
UMass Medical Center
Worcester, Massachusetts, United States
University of Michigan Health System
Ann Arbor, Michigan, United States
Medex Research Institute
Caro, Michigan, United States
Clinical Research Institute of Michigan, LLC
Chesterfield, Michigan, United States
Henry Ford Health System
Novi, Michigan, United States
Gastroenterology Associates of Western Michigan PLC
Wyoming, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Ehrhardt Clinical Research, LLC
Belton, Missouri, United States
Jefferson City Medical Group
Jefferson City, Missouri, United States
Mercy Research
Springfield, Missouri, United States
Saint Louis University
St Louis, Missouri, United States
Mercy Research
Washington, Missouri, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
AGA Clinical Research Associates LLC
Egg Harbor, New Jersey, United States
North Shore-LIJ Health System-Division of Rheumatology
Great Neck, New York, United States
NYU Langone Long Island Clinical Research Associates
Great Neck, New York, United States
Montefiore Medical Center PRIME
Lake Success, New York, United States
The Feinstein Institute for Medical Research PRIME
Manhasset, New York, United States
Winthrop University Hospital
Mineola, New York, United States
New York University School of Medicine
New York, New York, United States
Mount Sinai School of Medicine
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
Premier Medical Group of the Hudson Valley PC
Poughkeepsie, New York, United States
University of Rochester
Rochester, New York, United States
Asheville Gastroenterology Associates, P.A.
Asheville, North Carolina, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Carolina Center for Liver Disease
Charlotte, North Carolina, United States
Gaffney Health Services
Charlotte, North Carolina, United States
PhysiqueMed Clinical Trials
Greensboro, North Carolina, United States
Kinston Medical Specialists PA
Kinston, North Carolina, United States
Clinical Trials of America, LLC
Mount Airy, North Carolina, United States
Trial Management Associates LLC
Wilmington, North Carolina, United States
PMG Research of Winston-Salem
Winston-Salem, North Carolina, United States
Ohio Clinical Research Partners LLC
Akron, Ohio, United States
Clinical Inquest Center Ltd
Beavercreek, Ohio, United States
Dr. Deepak Sarwal, MD
Centerville, Ohio, United States
UC Health Clinical Trials Office
Cincinnati, Ohio, United States
Consultants for Clinical Research Inc.
Cincinnati, Ohio, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
Springfield Health Care Center
Springfield, Ohio, United States
Oklahoma Foundation for Digestive Research
Oklahoma City, Oklahoma, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Oregon Health & Science University
Portland, Oregon, United States
Main Line Gastroenterology
Havertown, Pennsylvania, United States
Drexel University College of Medicine
Philadelphia, Pennsylvania, United States
Childrens Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
University of Pennsylvania School of Medicine
Philadelphia, Pennsylvania, United States
Penn State University Milton S Hershey Medical Center
State College, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Carolinas Healthcare System
Charleston, South Carolina, United States
ClinSearch LLC
Chattanooga, Tennessee, United States
Gastro One
Germantown, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Texas Clinical Research Institute LLC
Arlington, Texas, United States
Gulf Coast Research Group LLC
Houston, Texas, United States
Methodist Hospital
Houston, Texas, United States
University of Texas Health Science Center at Houston
Houston, Texas, United States
Houston Endoscopy and Research Center
Houston, Texas, United States
Digestive Health Center
Pasadena, Texas, United States
Texas Digestive Disease Consultants - Southlake
Southlake, Texas, United States
Digestive Health Specialists of Tyler
Tyler, Texas, United States
University of Utah Division of Gastroenterology
Salt Lake City, Utah, United States
Advanced Clinical Research
West Jordan, Utah, United States
University of Virginia
Charlottesville, Virginia, United States
Charlottesville Medical Research Center
Charlottesville, Virginia, United States
Gastroenterology Associates of Tidewater
Chesapeake, Virginia, United States
Digestive and Liver Disease Specialists
Norfolk, Virginia, United States
Hunter Holmes Mcguire Ctr
Richmond, Virginia, United States
Virginia Mason Medical Center
Seattle, Washington, United States
Harborview Medical Center
Seattle, Washington, United States
Swedish Medical Center Cancer Institute Research
Seattle, Washington, United States
University of Washington School of Medicine
Seattle, Washington, United States
The Vancouver Clinic
Vancouver, Washington, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States
Dean Clinic Oregon
Madison, Wisconsin, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Concord Repatriation General Hospital
Concord, New South Wales, Australia
Centre For Digestive Diseases
Five Dock, New South Wales, Australia
Liverpool Hospital
Liverpool, New South Wales, Australia
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia
Mater Adult Hospital
South Brisbane, Queensland, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Royal Adelaide Hospital Institute of Medical and Veterinary Science
Adelaide, South Australia, Australia
Box Hill Hospital
Box Hill, Victoria, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, Australia
Ballarat Base Hospital
Ballarat, , Australia
Monash Medical Centre Clayton
Bentleigh East, , Australia
St Vincents Hospital Melbourne
Fitzroy, , Australia
Klinikum Klagenfurt am Wörtersee
Klagenfurt, , Austria
LKH - Universitätsklinikum der PMU Salzburg
Salzburg, , Austria
Krankenanstalt Rudolfstiftung Wien
Wein, , Austria
Hopital Universitaire des Enfants
Brussels, , Belgium
Cliniques Universitaires Saint-Luc
Brussels, , Belgium
UZ Antwerpen
Edegem, , Belgium
Universitair Ziekenhuis Gent
Ghent, , Belgium
CHU Sart Tilman
Liège, , Belgium
Alberta Childrens Hospital
Calgary, Alberta, Canada
GI Research Institute
Vancouver, British Columbia, Canada
Barrie GI Associates
Barrie, Ontario, Canada
LHSC - Victoria Hospital
London, Ontario, Canada
Mount Sinai Hospital
Toronto, Ontario, Canada
The Hospital for Sick Children
Toronto, Ontario, Canada
Centre de sante et de services sociaux Champlain Charles Le Moyne
Greenfield Park, Quebec, Canada
Royal University Hospital
Saskatoon, Saskatchewan, Canada
Clinical Hospital Centre Osijek
Osijek, , Croatia
Hepato-Gastroenterologie HK, s. r. o.
Hradec Králové, , Czechia
PreventaMed
Olomouc, , Czechia
CCBR Prague CZ
Prague, , Czechia
Thomayerova nemocnice
Prague, , Czechia
Aarhus Universitetshospital
Aahus C, , Denmark
Alborg Universitets Hospital
Aalborg, , Denmark
Hvidovre Hospital
Hvidovre, , Denmark
Koge Sygehus
Køge, , Denmark
Odense Universitetshospital
Odense C, , Denmark
Regionshospitalet Silkeborg
Silkeborg, , Denmark
Helsingin yliopistollinen keskussairaala
Helsinki, , Finland
Tampereen yliopistollinen sairaala
Tampere, , Finland
CHU Amiens Hopital Sud
Amiens, , France
CHU Besancon Hopital Jean Minjoz
Besançon, , France
Hopital Claude Huriez CHRU Lille
Lille, , France
Hopital Nord CHU Marseille
Marseille, , France
CHU Nice Hopital de lArchet 2
Nice, , France
Hopital Saint Louis
Paris, , France
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
CHU Reims Hopital Robert Debre
Reims, , France
CHU de Rouen Hopital Charles Nicolle
Rouen, , France
CHU de Toulouse Hopital Rangueil
Toulouse, , France
Hopital de Brabois Adultes
Vandœuvre-lès-Nancy, , France
Charite - Campus Virchow-Klinikum
Berlin, , Germany
DRK Kliniken Berlin Westend
Berlin, , Germany
St. Josef-Hospital
Bochum, , Germany
Staedisches Klinikum Brandenburg
Brandenburg, , Germany
Universitaetsklinikum Carl Gustav Carus
Dresden, , Germany
Universitaetsklinikum Erlangen
Erlangen, , Germany
Universitaetsklinikum EssenZentrum fuer Innere Medizin
Essen, , Germany
Kliniken Essen-Mitte
Essen, , Germany
Katholische Kliniken Ruhrhalbinsel GmbH
Essen, , Germany
Crohn Colitis Centrum Rhein Main
Frankfurt, , Germany
Asklepios Klinik Hamburg
Hamburg, , Germany
Universitaetsklinikum Schleswig Holstein Campus Kiel
Kiel, , Germany
EUGASTRO GmbH
Leipzig, , Germany
Gastroenterologische Praxis Minden
Minden, , Germany
Universitatsklinikum Regensburg
Regensburg, , Germany
Universitaetsklinikum Ulm
Ulm, , Germany
HELIOS Klinikum Wuppertal
Wuppertal, , Germany
General Hospital of Athens Evangelismos
Athens, , Greece
Athens Medical Center
Athens, , Greece
University General Hospital of Patras
Rio Patras, , Greece
Obudai Egeszsegugyi Centrum Kft.
Budapest, , Hungary
Semmelweis Egyetem
Budapest, , Hungary
Szent Margit Korhaz
Budapest, , Hungary
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Szent-Gyorgyi Albert TE AOK Borgyogy
Szeged, , Hungary
Rabin Medical Center
Petah Tikva, , Israel
Kaplan Medical Center
Rehovot, , Israel
Assaf Harofeh Medical Center
Ẕerifin, , Israel
Azienda Ospedaliera Universitaria Policlinico Sant Orsola Malpighi
Bologna, , Italy
Fondazione IRCCS CA Granda Ospedale Maggiore Policlinico
Milan, , Italy
Azienda Ospedaliera Di Padova
Padua, , Italy
Azienda Ospedaliera Vincenzo Cervello
Palermo, , Italy
Fondazione IRCCS Policlinico San Matteo
Pavia, , Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, , Italy
Universita Campus Bio-Medico di Roma
Roma, , Italy
Complesso Integrato Columbus
Roma, , Italy
Azienda Ospedaliera San Camillo Forlanini
Rome, , Italy
Azienda Ospedaliera Universitaria Policlinico Tor Vergata
Rome, , Italy
Azienda Ospedaliera Universitaria OO. RR. S. Giovanni di Dio e Ruggi dAragona
Salerno, , Italy
IRCCS Policlinico San Donato
San Donato Milanese, , Italy
Digestive Diseases Center Gastro
Riga, , Latvia
Riga East Clinical University Hospital clinic Gailezers
Riga, , Latvia
Amphia Ziekenhuis
Breda, , Netherlands
Erasmus Medisch Centrum
Rotterdam, , Netherlands
SP ZOZ Wojewodzki Szpital Zespolony im. J. Sniadeckiego
Bialystok, , Poland
Clinsante S.C. Osrodek Badan Klinicznych
Bydgoszcz, , Poland
Centrum Medyczne A-Z Clinic
Krakow, , Poland
Centrum Medyczne AMED
Lodz, , Poland
Nzoz Vivamed
Warsaw, , Poland
LexMedica Osrodek Badan Klinicznych
Wroclaw, , Poland
Hospital de Braga
Braga, , Portugal
Hospital da Senhora da Oliveira Guimaraes
Guimarães, , Portugal
Hospital Da Luz
Lisbon, , Portugal
Centro Hospitalar de Sao Joao, EPE
Porto, , Portugal
Centro Hospitalar do Alto Minho - Unidade Local de Saúde do Alto Minho, EPE
Viana do Castelo, , Portugal
CMI Dr. Tirnaveanu Amelita
Oradea, , Romania
Centrul de Gastroenterologie Dr. Goldis
Timișoara, , Romania
Medical Center Stolitsa-Medikl
Moscow, , Russia
SBEIHPE Novosibirsk State Medical University
Novosibirsk, , Russia
FSBI Scientific Research Institute of Physyology and Basic Medicine under the SB of RAMS
Novosibirsk, , Russia
SPb SBIH City Hospital # 26
Saint Petersburg, , Russia
NonState Healthcare Institution Central Clinical Hospital, Samara station JSC Russian Railways
Samara, , Russia
Clinical Center Bezanijska Kosa
Belgrade, , Serbia
GASTRO I., s.r.o.
Prešov, , Slovakia
Dong-A University Hospital
Busan, , South Korea
Pusan National University Hospital
Busan, , South Korea
Hanyang Univerisy Guri Hospital
Guri-si, , South Korea
CHA Bundang Medical Center CHA University
Seongnam-si, , South Korea
Seoul National University Bundang Hospital
Seongnam-si, , South Korea
Kyung Hee University Hospital
Seoul, , South Korea
Ewha Womans University Mokdong Hospital
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Kangbuk Samsung Hospital
Seoul, , South Korea
The Catholic University of Korea, St. Vincent's Hospital
Suwon, , South Korea
Yonsei University Wonju Severance Christian Hospital
Wŏnju, , South Korea
Hospital General Universitario de Alicante
Alicante, , Spain
Hospital del Mar
Barcelona, , Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Hospital Universitario de la Princessa
Madrid, , Spain
Hospital General Universitario Gregorio Maranon
Madrid, , Spain
Hospital Universitario Ramon y Cajal
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Complejo Hospitalario de Pontevedra
Pontevedra, , Spain
Hospital Universitario Miguel Servet
Zaragoza, , Spain
Danderyds Sjukhus AB
Stockholm, , Sweden
Inselspital - Universitaetsspital Bern
Bern, , Switzerland
Crohn-Colitis Zentrum Bern Gemeinschaftspraxis Balsiger Seibold und Partner
Bern, , Switzerland
Hopitaux Universitaires de Geneve-HUG
Geneva, , Switzerland
UniversitatSspital Zurich
Zurich, , Switzerland
Ankara University Medical Faculty
Ankara, , Turkey (Türkiye)
Hacettepe University Medical Faculty
Ankara, , Turkey (Türkiye)
Turkiye Yuksek Ihtisas Hospital
Ankara, , Turkey (Türkiye)
Gazi University Medical Faculty
Ankara, , Turkey (Türkiye)
Firat University Medical Faculty
Elâzığ, , Turkey (Türkiye)
Istanbul University Cerrahpasa Medical Faculty
Istanbul, , Turkey (Türkiye)
Acibadem Fulya Hospital
Istanbul, , Turkey (Türkiye)
Haydarpasa Numune Training and Research Hospital
Istanbul, , Turkey (Türkiye)
Istanbul Medeniyet Uni Goztepe Training&Res Hosp
Istanbul, , Turkey (Türkiye)
Marmara University Pendik Training and Research Hospital
Istanbul, , Turkey (Türkiye)
Ege University Medical Faculty
Izmir, , Turkey (Türkiye)
Dokuz Eylul University Izmir
Izmir, , Turkey (Türkiye)
Kocaeli Derince Training and Research Hospital
Kocaeli, , Turkey (Türkiye)
Inonu Uni. Med. Fac.
Malatya, , Turkey (Türkiye)
Mersin University Medical Faculty
Mersin, , Turkey (Türkiye)
CI of PH Kharkiv CCH #2
Kharkiv, , Ukraine
Treatment-Diagnostic Center of Private Enterprise of PMF Atsynus
Kirovohrad, , Ukraine
Kyiv City Clinical Hospital #1
Kyiv, , Ukraine
CI Odesa Regional Clinical Hospital
Odesa, , Ukraine
CI of SRC Sumy RCH Dept of Rheumatology Sumy SU MI
Sumy, , Ukraine
Ternopil City Communal Emergency Medical Care Hospital
Ternopil, , Ukraine
SRI of Invalid Rehabilitation EST Complex of Vinnytsia M.I.Pyrogov NMU MOHU
Vinnytsia, , Ukraine
SI Branch CH of Zaporizhzhia Station-2 of SE Prydniprovska Railway Dept of Surgery Zaporizhzhia SMU
Zaporizhia, , Ukraine
CI Zaporizhzhia Regional Clinical Hospital of ZRC
Zaporizhzhya, , Ukraine
Basingstoke and North Hampshire Hospital
Basingstoke, , United Kingdom
University Hospital Coventry
Coventry, , United Kingdom
Queen Elizabeth University Hospital
Glasgow, , United Kingdom
Hull Royal Infirmary
Hull, , United Kingdom
Royal London Hospital
London, , United Kingdom
University College London Hospitals
London, , United Kingdom
Manchester Royal Infirmary
Manchester, , United Kingdom
Nottingham University Hospitals Queens Medical Centre
Nottingham, , United Kingdom
Borders General Hospital
Roxburghshire, , United Kingdom
Countries
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Other Identifiers
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GED-0301-CD-003
Identifier Type: -
Identifier Source: org_study_id