Efficacy and Safety Study of Mongersen (GED-0301) for the Treatment of Subjects With Active Crohn's Disease

August 20, 2019 updated by: Celgene

A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Investigate the Efficacy and Safety of Mongersen (GED-0301) for the Treatment of Subjects With Active Crohn's Disease

The purpose of study is to test the effects of an experimental medication GED-0301 (mongersen) in patients who have active Crohn's disease. The study will test GED-0301 compared to placebo for 52 weeks. The study treatment is blinded which means that patients and the study doctor will not know which treatment has been assigned. Patients in this study will be allowed treatment with stable doses of oral aminosalicylates, oral corticosteroids, immunosupressants and antibiotics for the treatment of Crohn's disease.

After 12 weeks in the study until the end of the study, patients who do not have an improvement in their Crohns disease symptoms will have the option to enter a long term active treatment study. Participants who discontinued the study anytime or completed the study at Week 52 were then observed for an additional 4 weeks.

Study Overview

Status

Terminated

Conditions

Crohn Disease

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

701

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Australia
- - Ballarat, Australia, 3350
    - Ballarat Base Hospital
  - Bentleigh East, Australia, 3165
    - Monash Medical Centre Clayton
  - Fitzroy, Australia, 3065
    - St Vincents Hospital Melbourne
  - Heidelberg, Australia, 3084
    - Austin Hospital
  - Herston, Australia, 4006
    - Royal Brisbane and Women's Hospital
  - Kingswood, NSW, Australia, 2751
    - Nepean Hospital
- Australian Capital Territory
  - Bankstown, Australian Capital Territory, Australia, 2200
    - Bankstown-Lidcombe Hospital
- New South Wales
  - Camperdown, New South Wales, Australia, 2050
    - Royal Prince Alfred Hospital
  - Concord, New South Wales, Australia, 2139
    - Concord Repatriation General Hospital
  - Five Dock, New South Wales, Australia, 2046
    - Centre For Digestive Diseases
  - Liverpool, New South Wales, Australia, 2170
    - Liverpool Hospital
- Queensland
  - South Brisbane, Queensland, Australia, 4101
    - Mater Adult Hospital
  - Woolloongabba, Queensland, Australia, 4102
    - Princess Alexandra Hospital
- South Australia
  - Adelaide, South Australia, Australia, 5000
    - Royal Adelaide Hospital
  - Bedford Park, South Australia, Australia, 5042
    - Flinders Medical Centre
- Victoria
  - Box Hill, Victoria, Australia, 3128
    - Box Hill Hospital
  - Melbourne, Victoria, Australia, 3004
    - The Alfred Hospital
- Western Australia
  - Murdoch, Western Australia, Australia, 6150
    - Fiona Stanley Hospital
Austria
- - Graz, Austria, 8036
    - LKH Universitaetsklinikum Graz
  - Innsbruck, Austria, 6020
    - Medizinische Universitat Innsbruck
  - Klagenfurt, Austria, 9020
    - Klinikum Klagenfurt am Wörtersee
  - Linz, Austria, 4021
    - KH der Barmherzigen Brüder Linz
  - Ried I Innkreis, Austria, 4910
    - a.o.Krankenhaus d.Barmherz.Schwestern Ried
  - Salzburg, Austria, 5020
    - LKH - Universitätsklinikum der PMU Salzburg
  - Salzburg, Austria, 5020
    - Ordination Dr. Thomas Haas Darmpraxis Salzburg
  - St Veit An Der Glan, Austria, 9300
    - KH der Barmherzigen Brüder St.Veit an der Glan
  - Wein, Austria, 1030
    - Krankenanstalt Rudolfstiftung Wien
  - Wein, Austria, 1090
    - AKH Medizinische Universitat Wien
Belgium
- - Brussels, Belgium, 1090
    - Universitair Ziekenhuis Brussel
  - Bruxelles, Belgium, 1200
    - Cliniques Universitaires St Luc
  - Gent, Belgium, 9000
    - Universitair Ziekenhuis Gent
  - Leuven, Belgium, 3000
    - UZ Leuven
  - Liege, Belgium, 4000
    - CHU Sart Tilman
  - Mouscron, Belgium, 9000
    - Centre Hospitalier De Mouscron
Bulgaria
- - Lom, Bulgaria, 3600
    - MHAT Sv Nikolay Chudotvorets EOOD
  - Plovdiv, Bulgaria, 4002
    - MHAT Kaspela EOOD
  - Ruse, Bulgaria, 7002
    - MHAT Ruse AD
  - Sofia, Bulgaria, 1202
    - Second MHAT Sofia AD
  - Sofia, Bulgaria, 1407
    - City Clinic UMHAC EOOD
  - Sofia, Bulgaria, 1431
    - UMHAT Sv Ivan Rilski EAD
  - Sofia, Bulgaria, 1527
    - UMHAT Tsaritsa Yoanna - ISUL EAD
  - Sofia, Bulgaria, 1606
    - Fourth MHAT Sofia EAD
  - Sofia, Bulgaria, 1632
    - MHAT Doverie AD
Canada
- - Quebec, Canada, G1G 4A2
    - Recherche Clinique Sigma inc
- Alberta
  - Calgary, Alberta, Canada, T2N 1N4
    - University of Calgary
  - Edmonton, Alberta, Canada, T6G 2X8
    - University of Alberta
  - Edmonton, Alberta, Canada, T5H 4B9
    - GI Research Institute
  - Edmonton, Alberta, Canada, T6L 6K3
    - South Edmonton Gastroenterology
- British Columbia
  - Vancouver, British Columbia, Canada, V5Z 1M9
    - Vancouver General Hospital
  - Vancouver, British Columbia, Canada, V6Z 2K5
    - GI Research Institute
  - Victoria, British Columbia, Canada, V8V 3P9
    - PerCuro Clinical Research
- Manitoba
  - Brandon, Manitoba, Canada, R7A 0N7
    - Brandon Medical Arts Clinic
- Ontario
  - Barrie, Ontario, Canada, L4M 7G1
    - Barrie GI Associates
  - Hamilton, Ontario, Canada, L8N 3Z5
    - McMaster University Health Sciences Center
  - London, Ontario, Canada, N6A 5A5
    - London Health Science Center U. Hospital
  - London, Ontario, Canada, N6A 5W9
    - LHSC Victoria Hospital
  - Ottawa, Ontario, Canada, K1K 0T2
    - Montfort Hospital
  - Toronto, Ontario, Canada, M6H 3M1
    - Toronto Liver Centre
  - Toronto, Ontario, Canada, M5G 1X5
    - Mount Sinai Hospital
  - Toronto, Ontario, Canada, M3M 0B2
    - Humber River Hospital
  - Vaughan, Ontario, Canada, L4L 4Y7
    - Toronto Digestive Disease Associates Inc
  - Waterloo, Ontario, Canada, N2J 1C4
    - Medicine Professional Corporation
  - Windsor, Ontario, Canada, N8W 1E6
    - Tarabain Osman MD
- Quebec
  - Greenfield Park, Quebec, Canada, J4V 2H1
    - Centre de sante et de services sociaux Champlain Charles Le Moyne
  - Montreal, Quebec, Canada, H1M 1B1
    - Recherche GCP Research
  - Montreal, Quebec, Canada, H1T 2M4
    - Hopital Maisonneuve Rosemont dba CIUSSS de lEst de lIle de Montreal
  - Montreal, Quebec, Canada, H2X 3J4
    - CHUM Hopital Saint-Luc
  - Montreal, Quebec, Canada, H4A 3J1
    - McGill University Health Centre Glen Site Royal Victoria Hospital
  - Sherbrooke, Quebec, Canada, J1H5N4
    - CHUS Hopital Fleurimont
  - St Jerome, Quebec, Canada, J7Z 5T3
    - Recherche Medicale St Jerome Inc
- Saskatchewan
  - Saskatoon, Saskatchewan, Canada, S7N 0W8
    - Royal University Hospital
Croatia
- - Osijek, Croatia, 31000
    - Clinical Hospital Centre Osijek
  - Rijeka, Croatia, 51000
    - Clinical Hospital Centre Rijeka
  - Zagreb, Croatia, 10000
    - Clinical Hospital Centre Zagreb
  - Zagreb, Croatia, 10000
    - Clinical Hospital Sveti Duh
  - Zagreb, Croatia, 10000
    - Clinical Hospital Dubrava
  - Zagreb, Croatia, 10000
    - Clinical Hospital Merkur
Czechia
- - Brno, Czechia, 656 91
    - Fakultni nemocnice u sv Anny v Brne
  - Hradec Kralove, Czechia, 50012
    - Hepato-Gastroenterologie HK
  - Most, Czechia, 43401
    - Soukroma Gastroenterologicka ambulance a endoskopie
  - Olomouc, Czechia, 77900
    - PreventaMed
  - Pardubice, Czechia, 530 02
    - CCBR Czech as
  - Praha 3, Czechia, 13000
    - CCBR Prague CZ
  - Praha 7, Czechia, 170 04
    - IBD Centrum ISCARE IVF as
  - Usti nad Labem, Czechia, 40113
    - Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad La
  - Znojmo, Czechia, 669 02
    - Nemocnice Znojmo
Denmark
- - Aahus C, Denmark, 8000
    - Aarhus Universitetshospital
  - Frederikssund, Denmark, 3600
    - Nordsjaellands Hospital Frederikssund
  - Herlev, Denmark, 2730
    - Herlev Hospital
  - Hvidovre, Denmark, 2650
    - Hvidovre Hospital
  - Koge, Denmark, 4600
    - Koge Sygehus
  - Silkeborg, Denmark, 8600
    - Regionshospitalet Silkeborg
  - Ålborg, Denmark, 9000
    - Ålborg university Hospital
Estonia
- - Tallinn, Estonia, 10617
    - West Tallinn Central Hospital
  - Tartu, Estonia, 51014
    - Tartu University Hospital
Finland
- - Tampere, Finland, 33521
    - Tampereen Yliopistollinen Sairaala
  - Turku, Finland, 20700
    - Turunmaan sairaala
France
- - Amiens Cedex, France, 80054
    - CHU Amiens Hopital SUD
  - Besancon Cedex, France, 25030
    - CHU Besançon Hopital Jean Minjoz
  - Chambray les Tours, France, 37170
    - CHU Tours Hôpital Trousseau
  - Clermont-Ferrand, France, 63000
    - Chu Clermont Ferrand
  - Clichy cedex, France, 92110
    - Hopital Beaujon
  - Dijon, France, 21000
    - CHU Dijon - Hôpital Bocage Central
  - Grenoble cedex 9, France, 38043
    - CHU de Grenoble Hopital Nord
  - Le Kremlin Bicetre cedex, France, 94275
    - Groupement Hospitalier Sud Hopital Bicetre
  - Lille cedex, France, 59037
    - Hopital Claude Huriez CHRU Lille
  - Marseille cedex 20, France, 13915
    - Hopital Nord
  - Nantes Cedex 1, France, 44093
    - CHU Nantes Hôtel Dieu
  - Nice Cedex 3, France, 06200
    - CHU Nice Hopital de lArchet 2
  - Paris, France, 75012
    - Hopital Saint Antoine
  - Paris, France, 75475
    - Hopital Saint Louis
  - Pessac, France, 33604
    - Groupe Hospitalier Sud Hopital Haut Leveque USN
  - Pierre-Bénite Cedex, France, 69495
    - Centre Hospitalier Lyon Sud
  - Reims, France, 51092
    - CHU Reims Hopital Robert Debre
  - Rennes cedex 09, France, 35033
    - Chu Rennes Hopital Pontchaillou
  - Rouen Cedex, France, 76031
    - Chu de Rouen Hopital Charles Nicolle
  - Saint Etienne, France, 42055
    - CHU Saint Etienne Hopital Nord
  - Strasbourg Cedex, France, 67098
    - CHU Strasbourg Hôpital Hautepierre
  - Toulouse Cedex 09, France, 31059
    - CHU de Toulouse Hôpital Rangueil
  - Vandoeuvre les Nancy, France, 54511
    - Hôpital de Brabois Adultes
Germany
- - Berlin, Germany, 14050
    - DRK Kliniken Berlin Westend
  - Berlin, Germany, 13353
    - Charite Campus Virchow Klinikum
  - Berlin, Germany, 12200
    - Charite Universitaetsmedizin Berlin Campus Benjamin Franklin
  - Berlin, Germany, 14163
    - Krankenhaus Waldfriede e V
  - Bochum, Germany, 44789
    - Berufsgenossenschaftliches Universitaetsklinikum Bergmannsheil GmbH
  - Brandenburg an der Havel, Germany, 14770
    - Staedisches Klinikum Brandenburg
  - Dresden, Germany, 01307
    - Universitaetsklinikum Carl Gustav Carus TU Dresden
  - Duesseldorf, Germany, 40237
    - Zentrum fuer HIV und Hepatogastroenterologie GmbH
  - Erlangen, Germany, 91054
    - Universitaetsklinikum Erlangen
  - Essen, Germany, 45136
    - Kliniken Essen-Mitte
  - Essen, Germany, 45257
    - Katholische Kliniken Ruhrhalbinsel GmbH
  - Frankfurt, Germany, 60431
    - Agaplesion Markus Krankenhaus
  - Frankfurt, Germany, 60594
    - Crohn Colitis Centrum Rhein Main
  - Freiburg, Germany, 79106
    - Universitaetsklinikum FreiburgInnere Med.1, Haematologie
  - Halle, Germany, 06120
    - Universitaetsklinikum Halle Saale
  - Hamburg, Germany, 22559
    - Asklepios Klinik Hamburg
  - Hannover, Germany, 30625
    - Medizinische Hochschule Hannover
  - Heidelberg, Germany, 69120
    - UniversitatsKlinikum Heidelberg
  - Heidelberg, Germany, 69121
    - Praxis fuer Gastroenterologie Dr Ehehal Dr Helmstaedter
  - Jena, Germany, 07740
    - Universitaetsklinikum Jena
  - Kiel, Germany, 24105
    - Universitaetsklinikum Schleswig Holstein Campus Kiel
  - Leipzig, Germany, 4103
    - Eugastro GmbH
  - Leipzig, Germany, 04103
    - University Leipzig
  - Leipzig, Germany, 04105
    - Internistische Gemeinschaftspraxis f. Verdauungs- und Stoffwechselerkrankungen
  - Lueneburg, Germany, 21339
    - Medizinisches Zentrum Klinikum Lueneburg
  - Magdeburg, Germany, 39120
    - Universitaetsklinikum Magdeburg A oeR
  - Mannheim, Germany, 68167
    - Klinikum Mannheim GmbH Universitaetsklinikum
  - Minden, Germany, 32423
    - Gastroenterologische Praxis Minden
  - Muenchen, Germany, 80331
    - Isar Klinik GmbH
  - Muenster, Germany, 48149
    - Universitaetsklinikum Muenster
  - Muenster, Germany, 48159
    - Gastro Campus Research
  - München, Germany, 81377
    - Klinikum der Universitaet Muenchen
  - Niedersachsen, Germany, 38126
    - Staedtisches Klinikum Braunschweig gGmbH Standort Salzdahlumer
  - Regensburg, Germany, 93053
    - Universitaetsklinikum Regensburg
  - Ulm, Germany, 89081
    - Universitaetsklinikum Ulm
Greece
- - Alexandroupolis, Greece, 68100
    - University General Hospital of Alexandroupolis
  - Athens, Greece, 10676
    - General Hospital of Athens Evangelismos
  - Athens, Greece, 15125
    - Athens Medical Center
  - Athens, Greece, 18454
    - General Hospital of Nikaea Piraeus Ag. Panteleimon
  - Heraklion, Greece, 71409
    - General Hospital of Heraklion Benizeleio Pananeio
  - Heraklion, Greece, 711 10
    - University General Hospital of Heraklion
  - Ioannina, Greece, 45500
    - University General Hospital of Ioannina
  - Rio Patras, Greece, 26500
    - University General Hospital of Patras
  - Thessaloniki, Greece, 54007
    - Anticancer Hospital of Thessaloniki THEAGENIO
  - Thessaloniki, Greece, 54642
    - General Hospital of Thessaloniki Hippokration
Hungary
- - Balatonfured, Hungary, 8230
    - DRC Gyogyszervizsgalo Kozpont Kft
  - Budapest, Hungary, 1062
    - Magyar Honvedseg Egeszsegugyi Kozpont
  - Budapest, Hungary, 1136
    - Pannónia Magánorvosi Centrum
  - Budapest, Hungary, 1125
    - Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak
  - Budapest, Hungary, 1033
    - Clinexpert Egeszsegugyi Szolg es Ker Kft
  - Budapest, Hungary, 1083
    - Semmelweis Egyetem AOK
  - Budapest, Hungary, 1088
    - Semmelweis Egyetem AOK
  - Budapest, Hungary, 1139
    - Endomedix Diagnosztikai Kozpont
  - Debrecen, Hungary, 4032
    - Debreceni Egyetem Klinikai Kozpont
  - Dunaujvaros, Hungary, 2400
    - Szent Pantaleon Kórház Rendelőintézet Dunaújváros
  - Eger, Hungary, 3300
    - Markhot Ferenc Oktato Korhaz es Rendelointezet
  - Gyor, Hungary, 9024
    - Petz Aladar Megyei Oktato Korhaz
  - Gyula, Hungary, 5700
    - Békés Megyei Pándy Kálmán Kórház
  - Kaposvar, Hungary, 7400
    - Somogy Megyei Kaposi Mor Oktato Korhaz
  - Mohacs, Hungary, 7700
    - Mohacsi Korhaz
  - Nyiregyhaza, Hungary, 4400
    - SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz
  - Szeged, Hungary, 6722
    - Mazso-Pharma Kutatas-fejlesztesi Kft
  - Szekesfehervar, Hungary, 8000
    - Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
  - Szekszard, Hungary, 7100
    - CLINFAN Szolgáltató Kft
Israel
- - Afula, Israel, 18341
    - Haemek Medical Center
  - Beer Sheva, Israel, 84101
    - Soroka University Medical Center
  - Haifa, Israel, 3109601
    - Rambam Health Care Campus
  - Holon, Israel, 58100
    - Wolfson Medical Center
  - Jerusalem, Israel, 91031
    - Shaare Zedek Medical Center
  - Jerusalem, Israel, 91120
    - Hadassah University Hospital
  - Petah Tikva, Israel, 49100
    - Rabin Medical Center
  - Ramat Gan, Israel, 52621
    - Chaim Sheba Medical Center
  - Rechovot, Israel, 76100
    - Kaplan Medical Center
  - Tel Aviv, Israel, 64239
    - Tel Aviv Sourasky Medical Center Department of Hematology
  - Zerifin, Israel, 70300
    - Assaf Harofeh Medical Center
Italy
- - Bari, Italy, 70124
    - Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
  - Bologna, Italy, 40138
    - Azienda Ospedaliera Universitaria Policlinico Sant Orsola Malpighi
  - Messina, Italy, 98125
    - Azienda Ospedaliera Universitaria Policlinico G Martino
  - Milano, Italy, 20122
    - Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
  - Naples, Italy, 80131
    - Seconda Università degli Studi di Napoli
  - Napoli, Campania, Italy, 80131
    - Azienda Ospedaliera Universitaria Federico II
  - Padova, Italy, 35128
    - Hospital of Di Padova
  - Palermo, Italy, 90146
    - Azienda Ospedaliera Vincenzo Cervello
  - Pavia, Italy, 27100
    - Fondazione IRCCS Policlinico San Matteo
  - Pisa, Italy, 56124
    - Azienda Ospedaliero Universitaria Pisana
  - Roma, Italy, 00168
    - Complesso Integrato Columbus
  - Roma, Italy, 00168
    - Policlinico Universitario Agostino Gemelli
  - Roma, Italy, 00157
    - Ospedale Sandro Pertini
  - Roma, Italy, 00128
    - Universita Campus Bio-Medico di Roma
  - Rome, Italy, 00152
    - Azienda Ospedaliera San Camillo Forlanini
  - Rome, Italy, 133
    - Azienda Ospedaliera Universitaria Policlinico Tor Vergata
  - Rozzano (MI), Italy, 20089
    - Istituto Clinico Humanitas
  - Salerno, Italy, 84131
    - Azienda Ospedaliera Universitaria OO. RR. S. Giovanni di Dio e Ruggi dAragona
  - San Donato Milanese, Italy, 20097
    - IRCCS Policlinico San Donato
  - San Giovanni Rotondo FG, Italy, 71013
    - IRCCS Ospedale Casa Sollievo della Sofferenza
Korea, Republic of
- - Busan, Korea, Republic of, 49241
    - Pusan National University Hospital
  - Busan, Korea, Republic of, 49201
    - Dong-A University Hospital
  - Daegu, Korea, Republic of, 42415
    - Yeungnam University Medical Center
  - Guri-si, Korea, Republic of, 11923
    - Hanyang Univerisy Guri Hospital
  - Seongnam-si, Korea, Republic of, 13620
    - Seoul National University Bundang Hospital
  - Seongnam-si,, Korea, Republic of, 13496
    - CHA Bundang Medical Center CHA University
  - Seoul, Korea, Republic of, 135-710
    - Samsung Medical Center
  - Seoul, Korea, Republic of, 05505
    - Asan Medical Center
  - Seoul, Korea, Republic of, 02447
    - Kyung Hee University Hospital
  - Seoul, Korea, Republic of, 136-705
    - Korea University Anam Hospital
  - Seoul, Korea, Republic of, 03181
    - Kangbuk Samsung Hospital
  - Seoul, Korea, Republic of, 120-752
    - Severance Hospital, Yonsei University Health System
  - Seoul, Korea, Republic of, 158-710
    - Ewha Womans University Mokdong Hospital
  - Suwon-si, Korea, Republic of, 16247
    - The Catholic University of Korea, St.Vicent's Hospital
Latvia
- - Riga, Latvia, LV1002
    - Pauls Stradins Clinical University Hospital
  - Riga, Latvia, LV-1006
    - Digestive Diseases Center GASTRO
  - Riga, Latvia, LV-1038
    - Riga East Clinical University Hospital clinic Gailezers
Malaysia
- - Kelantan, Malaysia, 16150
    - Hospital Universiti Sains Malaysia
- Kedah
  - Alor Setar, Kedah, Malaysia, 5460
    - Hospital Sultanah Bahiyah
- Kelantan
  - Kota Bahru, Kelantan, Malaysia, 15586
    - Hospital Raja Perempuan Zainab Ii
- Selangor
  - Ampang, Selangor, Malaysia, 68000
    - Hospital Ampang
- Wilayah Persekutuan Kuala Lumpur
  - Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia, 59100
    - University Malaya Medical Centre
Netherlands
- - Amsterdam, Netherlands, 1081 HV
    - VU Medisch Centrum
  - Amsterdam, Netherlands, 1105
    - Academisch Medisch Centrum
  - Breda, Netherlands, 4819 EV
    - Amphia Ziekenhuis
  - Groningen, Netherlands, 9713 GZ
    - Universitair Medisch Centrum Groningen
  - Leiden, Netherlands, 2333 ZA
    - Leiden Universitair Medisch Centrum
  - Leidschendam, Netherlands, 2262 BA
    - Medisch Centrum Haaglanden,Antoniushoeve
  - Nijmegen, Netherlands, 6525 GA
    - Radboudumc
  - Sittard-Geleen, Netherlands, 6162 BG
    - Zuyderland Medisch Centrum
  - Tilburg, Netherlands, 5022 GC
    - St. Elisabeth Ziekenhuis
  - Utrecht, Netherlands, 3584 CX
    - University Medical Center Utrecht
New Zealand
- - Hamilton, New Zealand, 3204
    - Waikato Hospital
Norway
- - Fredrikstad, Norway, 1603
    - Sykehuset ostfold Fredrikstad
  - Lørenskog, Norway, 1478
    - Akershus Universitetssykehus HF
  - Oslo, Norway, 0424
    - Oslo universitetssykehus HF Ullevål
  - Oslo, Norway, N-0027
    - Oslo Universitetssykehus Rikshospitalet
  - Stavanger, Norway, 4011
    - Stavanger Unviversitetssjukehus Helse Stavanger HF
Poland
- - Bialystok, Poland, 15-275
    - SP ZOZ Wojewodzki Szpital Zespolony im. J. Sniadeckiego
  - Bydgoszcz, Poland, 85-794
    - Clinsante S.C. Osrodek Badan Klinicznych
  - Gdansk, Poland, 80-952
    - Uniwersyteckie Centrum Kliniczne
  - Kielce, Poland, 25-364
    - Niepubliczny Zaklad Opieki Zdrowotnej POLIMEDICA
  - Knurow, Poland, 44-190
    - Indywidualna Praktyka Lekarska Maciej Zymla
  - Krakow, Poland, 30-349
    - Centrum Medyczne Plejady
  - Krakow, Poland, 30-415
    - LUX MED Sp. z o.o.
  - Krakow, Poland, 31-531
    - SPZOZ Szpital Uniwersytecki w Krakowie
  - Lodz, Poland, 90-647
    - SPZOZ Uniwersytecki Szpital Kliniczny im. Wojskowej Akademii Medycznej - Centralny Szpital Weteranow
  - Lodz, Poland, 91-365
    - Centrum Medyczne AMED
  - Lublin, Poland, 20-582
    - GASTROMED Sp.zo.o.
  - Poznan, Poland, 61-113
    - Ai Centrum Medyczne Sp. Z O.O. Sp.K.
  - Rzeszow, Poland, 35-055
    - Centrum Medyczne MEDYK
  - Sopot, Poland, 81-756
    - Endoskopia Sp. z o.o.
  - Warsaw, Poland, 03-580
    - NZOZ Vivamed
  - Wroclaw, Poland, 53-114
    - LexMedica Osrodek Badan Klinicznych
Portugal
- - Braga, Portugal, 4710-243
    - Hospital de Braga
  - Coimbra, Portugal, 3000-075
    - Centro Hospitalar E Universitario de Coimbra EPE
  - Guimaraes, Portugal, 4835-044
    - Hospital Da Senhora Da Oliveira Guimarăes
  - Lisboa, Portugal, 1500-650
    - Hospital da Luz
  - Porto, Portugal, 4200-319
    - Centro Hospitalar de Sao Joao, EPE
  - Viana do Castelo, Portugal, 4904-858
    - Centro Hospitalar do Alto Minho - Unidade Local de Saúde do Alto Minho, EPE
Romania
- - Bucuresti, Romania, 010719
    - S.C MedLife S.A
  - Cluj Napoca, Romania, 400132
    - Tvm Med Serv Srl
  - Iasi, Romania, 700111
    - Spitalul Clinic Judetean de Urgente Sf. Spiridon
  - Oradea, Romania, 410066
    - CMI Dr. Tirnaveanu Amelita
  - Timisoara, Romania, 300002
    - Centrul de Gastroenterologie Dr. Goldis
Russian Federation
- - Irkutsk, Russian Federation, 664049
    - Irkutsk State Medical Academy of Continuing Education
  - Krasnoyarsk, Russian Federation, 660022
    - TSBIH Territorial Clinical Hospital
  - Moscow, Russian Federation, 115088
    - Medical Center Stolitsa-Medikl
  - Nizhny Novgorod, Russian Federation, 603126
    - SBHI of NN region RCH of NN n.a. N.A.Semashko
  - Novosibirsk, Russian Federation, 630054
    - SBEIHPE Novosibirsk State Medical University
  - Novosibirsk, Russian Federation, 630087
    - RSHI State Novosibirsk Regional Clinical Hospital
  - Novosibirsk, Russian Federation, 630117
    - FSBI Scientific Research Institute of Physyology and Basic Medicine under the SB of RAMS
  - Omsk, Russian Federation, 644013
    - BHI of Omsk region Clinical Oncology Dispensary
  - Omsk, Russian Federation, 644043
    - SBEI of HPE Omsk State Medical Academy Ministry of healthcare of RF
  - Perm, Russian Federation, 614068
    - SBIH of Perm territory City Clinical Hospital 2 na Fedor Khristoforovich Gral
  - Pushkin, Russian Federation, 196603
    - Evromedservis
  - Rostov-on-Don, Russian Federation, 344022
    - SEIHPE Rostov State Medical University of MoH of RF
  - Saint-Petersburg, Russian Federation, 196247
    - SPb SBIH City Hospital # 26
  - Saint-Petersburg, Russian Federation, 194104
    - City Mariinskaya Hospital
  - Samara, Russian Federation, 443001
    - Private Educational Institution of Higher Education Medical University Reaviz
  - Samara, Russian Federation, 443041
    - NonState Healthcare Institution Central Clinical Hospital, Samara station JSC Russian Railways
  - Saratov, Russian Federation, 410053
    - SHI Regional Clinical Hospital
  - Tosno, Russian Federation, 187000
    - SBI of Healthcare of Leningrad region Clinical Interregional Hospital of Tosno
  - Yaroslavl, Russian Federation, 150030
    - SBHI of Yaroslavl Region Clinical Hospital 8
Serbia
- - Belgrade, Serbia, 11000
    - Military Medical Academy
  - Belgrade, Serbia, 11080
    - Clinical Center Bezanijska kosa
  - Belgrade, Serbia, 11000
    - Clinical Center of Serbia
  - Belgrade, Serbia, 11000
    - Clinical Center Zvezdara
  - Belgrade, Serbia, 11080
    - Clinical Center Zemun
  - Kragujevac, Serbia, 34000
    - Clinical Center Kragujevac
  - Nis, Serbia, 18000
    - Clinical Center Nis
Slovakia
- - Banska Bystrica, Slovakia, 975 17
    - Fakultna nemocnica s poliklinikou F. D. Roosevelta
  - Bardejov, Slovakia, 08501
    - Alian s.r.o.
  - Bratislava, Slovakia, 82606
    - Univerzitna nemocnica Bratislava Nemocnica Ruzinov
  - Bratislava, Slovakia, 83104
    - Gastroentero-Hepatologicke centrum THALION
  - Humenne, Slovakia, 06601
    - Nemocnica A.Lena Humenne n o
  - Kosice, Slovakia, 04022
    - B & B MED, s.r.o.
  - Lucenec, Slovakia, 984 39
    - Kardio 1 S.R.O.
  - Malacky, Slovakia, 90122
    - Gastroeneterologicka ambulancia MUDr. Peter Hegyi s.r.o.
  - Nitra, Slovakia, 949 01
    - Fakultna nemocnica Nitra
  - Nitra, Slovakia, 94901
    - KM Management, spol. s r.o.
  - Presov, Slovakia, 080 01
    - GASTRO I., s.r.o.
  - Roznava, Slovakia, 04801
    - Nemocnica s poliklinikou sv Barbory Roznava a s
  - Zilina, Slovakia, 01207
    - Fakultna nemocnica s poliklinikou Zilina
Spain
- - Badalona, Spain, 08916
    - Hospital Universitari Germans Trias i Pujol
  - Barcelona, Spain, 08003
    - Hospital Del Mar
  - Barcelona, Spain, 08036
    - Hospital Clinic i Provincial de Barcelona
  - Cordoba, Spain, 14004
    - Hospital Universitario Reina Sofia
  - Madrid, Spain, 28034
    - Hospital Universitario Ramon y Cajal
  - Madrid, Spain, 28006
    - Hospital Universitario de la Princesa
  - Majadahonda, Spain, 28222
    - Hospital Universitario Puerta de Hierro Majadahonda
  - Sabadell, Spain, 08208
    - Corporacion Sanitaria Parc Tauli
  - San Sebastian de los Reyes, Spain, 28702
    - Hospital Universitario Infanta Sofía
  - Sevilla, Spain, 41013
    - Hospital Universitario Virgen del Rocio
  - Sevilla, Spain, 41017
    - Hospital Universitario Virgen Macarena
  - Zaragoza, Spain, 50009
    - Hospital Universitario Miguel Servet
Sweden
- - Stockholm, Sweden, 11883
    - Sodersjukhuset
  - Stockholm, Sweden, 18288
    - Danderyds Sjukhus AB
  - Uppsala, Sweden, 75185
    - Akademiska Sjukhuset
Switzerland
- - Basel, Switzerland, 4031
    - Universitaetsspital Basel
  - Bern, Switzerland, 3010
    - Inselspital - Universitaetsspital Bern
  - Bern, Switzerland, 3012
    - Crohn-Colitis Zentrum Bern Gemeinschaftspraxis Balsiger Seibold und Partner
  - St. Gallen, Switzerland, 9000
    - Kantonsspital St.Gallen
  - Zuerich, Switzerland, 8091
    - UniversitaetsSpital Zuerich
Turkey
- - Ankara, Turkey, 06100
    - Hacettepe University Medical Faculty
  - Ankara, Turkey, 06100
    - Ankara University Medical Faculty
  - Ankara, Turkey, 06500
    - Gazi University Medical Faculty
  - Ankara, Turkey, 06100
    - Turkiye Yuksek Ihtisas Hospital
  - Elazig, Turkey, 23119
    - Firat University Medical Faculty
  - Gaziantep, Turkey, 27310
    - Gaziantep University Medical Faculty Sahinbey Educational Research Hospital
  - Istanbul, Turkey, 34349
    - Acibadem Fulya Hospital
  - Istanbul, Turkey, 34668
    - Haydarpasa Numune Training and Research Hospital
  - Istanbul, Turkey, 34854
    - Istanbul Medeniyet Uni Goztepe Training&Res Hosp
  - Istanbul, Turkey, 34098
    - Istanbul University Cerrahpasa Medical Faculty Hospital
  - Istanbul, Turkey, 31755
    - Yeditepe University Medical School Hospital
  - Istanbul, Turkey, 34899
    - Marmara University Pendik Training and Research Hospital
  - Izmir, Turkey, 35100
    - Ege University Medical Faculty
  - Malatya, Turkey, 44280
    - Inonu Uni. Med. Fac.
  - Mersin, Turkey, 33020
    - Mersin University Medical Faculty
  - Umuttepe Kocaeli, Turkey, 41380
    - Kocaeli Derince Training and Research Hospital
Ukraine
- - Chernivtsi, Ukraine, 58001
    - RCI Chernivtsi Regional Clinical Hospital Dept of Surgery Bukovinian SMU
  - Kharkiv, Ukraine, 61037
    - CI of PH Kharkiv CCH #2
  - Kharkiv, Ukraine, 61039
    - GI L.T.Malaya Therapy National Institute of the NAMS of Ukraine
  - Kirovohrad, Ukraine, 25006
    - Treatment-Diagnostic Center of Private Enterprise of PMF Atsynus
  - Kyiv, Ukraine, 04053
    - SI Republican Clinical Hospital of the MOHU Dept of Gastroenterology O.O.Bogomolets NMU
  - Kyiv, Ukraine, 02091
    - Kyiv City Clinical Hospital #1
  - Kyiv, Ukraine, 01030
    - Ukrainian-German Antiulcer Gastroenterological Center BYK-Kyiv LLC
  - Lviv, Ukraine, 79010
    - Lviv Regional Clinical Hospital D Halytskyi Lviv NMU
  - Lviv, Ukraine, 79013
    - Lviv Municipal City Clinical Hospital #5 Dept of Therapy D.Halytsky Lviv NMU
  - Odessa, Ukraine, 65025
    - CI Odesa Regional Clinical Hospital
  - Odessa, Ukraine, 65114
    - Communal Institution City Policlinic #20 Cabinet of Gastroenterology
  - Poltava, Ukraine, 36011
    - M.V. Sklifosovskyi Poltava RCH Outpatient UMSA HSEIU Ukrainian Medical Stomatological Academy
  - Sumy, Ukraine, 40022
    - CI of SRC Sumy RCH Dept of Rheumatology Sumy SU MI
  - Ternopil, Ukraine, 46000
    - Ternopil City Communal Emergency Medical Care Hospital
  - Vinnytsia, Ukraine, 21018
    - M.I. Pyrogov VRCH Dept of Gastroenterology M.I. Pyrogov VNMU
  - Vinnytsia, Ukraine, 21029
    - SRI of Invalid Rehabilitation EST Complex of Vinnytsia M.I.Pyrogov NMU MOHU
  - Zaporizhia, Ukraine, 69104
    - SI Branch CH of Zaporizhzhia Station-2 of SE Prydniprovska Railway Dept of Surgery Zaporizhzhia SMU
  - Zaporozhje, Ukraine, 69600
    - CI Zaporizhzhia Regional Clinical Hospital of ZRC
United Kingdom
- - Birmingham, United Kingdom, B152WB
    - Queen Elizabeth Hospital
  - Bristol, United Kingdom, BS1 3NX
    - Bristol Royal Infirmary
  - Exeter, United Kingdom, EX2 5DW
    - Royal Devon and Exeter Hospital Wonford
  - Glasgow, United Kingdom, G51 4TF
    - Queen Elizabeth University Hospital
  - Glasgow, Scotland, United Kingdom, G4 OSF UK
    - Glasgow Royal Infirmary
  - Hull, United Kingdom, HU3 2JZ
    - Hull Royal Infirmary
  - London, United Kingdom, E1 1BB
    - Royal London Hospital
  - London, United Kingdom, W2 1NY
    - St Marys Hospital
  - Manchester, United Kingdom, M13 9WL
    - Manchester Royal Infirmary
  - Manchester, United Kingdom, M23 9LT
    - University Hospital of South Manchester NHS Foundation Trust -Wythenshawe Hospital - North West Lung
  - Nottingham, United Kingdom, NG7 2UH
    - Nottingham University Hospitals Queens Medical Centre
  - Oxford, United Kingdom, OX3 9DU
    - John Radcliffe Hospital
  - Roxburghshire, United Kingdom, TD6 9BS
    - Borders General Hospital
  - Shrewsbury, United Kingdom, SY38XQ
    - Royal Shrewsbury Hospital
  - Southhampton, United Kingdom, SO01 6YD
    - Southampton General Hospital
United States
- Alabama
  - Huntsville, Alabama, United States, 35802
    - ADDC Research LLC
- Arizona
  - Mesa, Arizona, United States, 85024
    - Arizona Digestive Health
  - Phoenix, Arizona, United States, 85054
    - Mayo Clinic Arizona
  - Scottsdale, Arizona, United States, 85260-1315
    - Colon & Digestive Health Specialists
  - Sun City, Arizona, United States, 85351
    - Arizona Digestive Health
- Arkansas
  - Little Rock, Arkansas, United States, 72205
    - Gastroenterology Associates PA
- California
  - Anaheim, California, United States, 92801
    - HCP Clinical Research LLC
  - Encino, California, United States, 91436
    - T. Joseph Raoof MD Inc
  - Garden Grove, California, United States, 92843
    - Valley View Internal Medicine
  - Lancaster, California, United States, 93534
    - Om Research
  - Los Angeles, California, United States, 90048
    - Cedars-Sinai Medical Center
  - Los Angeles, California, United States, 90032
    - University of Southern California Medical Center
  - Mission Hills, California, United States, 91345
    - FACEY Medical Foundation
  - San Diego, California, United States, 902123
    - Medical Associates Research Group Inc.
  - San Diego, California, United States, 92103
    - Clinical Applications Laboratories Inc
  - San Francisco, California, United States, 94158
    - University of California at San Francisco
  - Ventura, California, United States, 93003
    - Ventura Clinical Trials
- Colorado
  - Aurora, Colorado, United States, 80045
    - University of Colorado
  - Lafayette, Colorado, United States, 80026
    - Innovative Clinical Research
- Connecticut
  - Bristol, Connecticut, United States, 06010
    - Connecticut Gastroenterology Institute
  - Hamden, Connecticut, United States, 06518
    - Medical Research Center of Connecticut LLC
  - Hartford, Connecticut, United States, 06106
    - Connecticut GI PC Research Division
  - New Haven, Connecticut, United States, 06520
    - Yale University
- Florida
  - Gainesville, Florida, United States, 32607
    - Florida Medical Research - Southeastern Integrated Medical
  - Gainesville, Florida, United States, 32607
    - Sarkis Clinical Trials - Parent
  - Jacksonville, Florida, United States, 32256
    - Borland-Groover Clinic
  - Largo, Florida, United States, 33777
    - Florida Center for Gastroenterology
  - Miami, Florida, United States, 33155
    - Cordova Research Institute
  - Miami, Florida, United States, 33155
    - Advance Medical Research Center
  - Miami, Florida, United States, 33155
    - My Community Research Center inc
  - Miami, Florida, United States, 33155
    - Sanitas Research
  - Miami Springs, Florida, United States, 33166
    - Galiz Research LLC
  - Naples, Florida, United States, 34102
    - Gastroenterology Group Of Naples
  - Orlando, Florida, United States, 32803
    - Center for Digestive Health
  - Orlando, Florida, United States, 32801
    - GCRM
  - Plantation, Florida, United States, 33322
    - BRCR Medical Center Inc.
  - Port Orange, Florida, United States, 32127
    - Advanced Medical Research Center
  - Saint Augustine, Florida, United States, 32086
    - East Coast Institute For Research LLC
  - Weston, Florida, United States, 33331
    - Cleveland Clinic Florida Weston
  - Winter Park, Florida, United States, 32789
    - Shafran Gastroenterology Center
- Georgia
  - Atlanta, Georgia, United States, 30342
    - Atlanta Gastroenterology Associates, LLC
  - Augusta, Georgia, United States, 30912
    - Georgia Regents University
  - Columbus, Georgia, United States, 31904
    - Columbus Regional Research Institute
  - Suwanee, Georgia, United States, 30024
    - Atlanta Gastroenterology Specialists PC
- Idaho
  - Idaho Falls, Idaho, United States, 83404
    - Grand Teton Research Group PLLC
- Illinois
  - Chicago, Illinois, United States, 60637
    - University of Chicago Medical Center
  - Chicago, Illinois, United States, 60611
    - Northwestern University-Feinberg School of Medicine
  - Highland Park, Illinois, United States, 60035
    - Northshore University Healthsystem
- Indiana
  - Indianapolis, Indiana, United States, 46202
    - Indiana University
- Iowa
  - Clive, Iowa, United States, 50325
    - Iowa Digestive Disease Center
- Kansas
  - Pratt, Kansas, United States, 67124
    - Health Science Research Center, LLC
  - Wichita, Kansas, United States, 67207
    - Heartland Research Associates LLC
  - Wichita, Kansas, United States, 67208
    - Via Christi Research a division of Via Christi Hospitals Wichita Inc
- Kentucky
  - Bowling Green, Kentucky, United States, 42101
    - Graves Gilbert Clinic
  - Lexington, Kentucky, United States, 40504
    - University of Kentucky Medical Center
  - Louisville, Kentucky, United States, 40202
    - University of Louisville
- Louisiana
  - Baton Rouge, Louisiana, United States, 70809
    - Gastroenterology Associates LLC
  - Lake Charles, Louisiana, United States, 70601
    - Clinical Trials of SW Louisiana LLC
  - Shreveport, Louisiana, United States, 71103
    - Louisiana Research Center LLC
- Maryland
  - Baltimore, Maryland, United States, 21201
    - University of Maryland Medical Center
  - Baltimore, Maryland, United States, 21218
    - Johns Hopkins University School of Medicine
  - Chevy Chase, Maryland, United States, 20815
    - Metropolitan Gastroenterology
  - Columbia, Maryland, United States, 21045
    - Gastro Center of Maryland
- Massachusetts
  - Boston, Massachusetts, United States, 02118
    - Boston Medical Center
  - Brockton, Massachusetts, United States, 02302
    - Commonwealth Clinical Studies PLLC
  - Worcester, Massachusetts, United States, 01655
    - UMASS Medical Center
- Michigan
  - Ann Arbor, Michigan, United States, 48109
    - University of Michigan Health System
  - Caro, Michigan, United States, 48723
    - Medex Research Institute
  - Chesterfield, Michigan, United States, 48047
    - Clinical Research Institute of Michigan, LLC
  - Novi, Michigan, United States, 48377
    - Henry Ford Medical Center - New Center One
  - Wyoming, Michigan, United States, 49519
    - Gastroenterology Associates of Western Michigan PLC
- Minnesota
  - Minneapolis, Minnesota, United States, 55455
    - University of Minnesota
  - Rochester, Minnesota, United States, 55905
    - Mayo Clinic
- Missouri
  - Belton, Missouri, United States, 64012
    - Ehrhardt Clinical Research LLC
  - Jefferson City, Missouri, United States, 65203
    - Jefferson City Medical Group
  - Saint Louis, Missouri, United States, 63110 - 0250
    - Saint Louis University
  - Springfield, Missouri, United States, 65806
    - Mercy Research
  - Washington, Missouri, United States, 63090
    - Mercy Clinic East Communities d/b/a Mercy Health Research
- New Hampshire
  - Lebanon, New Hampshire, United States, 03756
    - Dartmouth-Hitchcock Medical Center
- New Jersey
  - Egg Harbor Township, New Jersey, United States, 08234
    - Aga Clinical Research Associates LLC
- New Mexico
  - Albuquerque, New Mexico, United States, 87109
    - Southwest Gastroenterology Associates PC
- New York
  - Flushing, New York, United States, 11355
    - Sing Chan Private Practice
  - Great Neck, New York, United States, 11021
    - NYU Langone Nassau Gastroenterology Associates
  - Lake Success, New York, United States, 11041
    - Montefiore Medical Center Prime
  - Manhasset, New York, United States, 11030
    - The Feinstein Institute for Medical Research PRIME
  - Mineola, New York, United States, 11501
    - Winthrop University Hospital
  - New Hyde Park, New York, United States, 11040
    - North Shore Long Island Jewish Health System
  - New York, New York, United States, 10032
    - Columbia University Medical Center
  - New York, New York, United States, 10016
    - New York University School of Medicine
  - New York, New York, United States, 10029
    - Icahn School of Medicine at Mount Sinai
  - New York, New York, United States, 10016
    - Concord Medical Group PRIME
  - New York, New York, United States, 10021
    - New York - Presbyterian/Weill Cornell Medical Center
  - Poughkeepsie, New York, United States, 12601
    - Premier Medical Group of the Hudson Valley PC
  - Rochester, New York, United States, 14642
    - University of Rochester
- North Carolina
  - Asheville, North Carolina, United States, 28801
    - Asheville Gastroenterology Associates, PA
  - Chapel Hill, North Carolina, United States, 27514
    - University of North Carolina at Chapel Hill
  - Charlotte, North Carolina, United States, 28207
    - Carolinas Medical Center
  - Charlotte, North Carolina, United States, 28205
    - Gaffney Health Services
  - Charlotte, North Carolina, United States, 28203
    - Carolina Center for Liver Disease
  - Greensboro, North Carolina, United States, 27455
    - PhysiqueMed Clinical Trials
  - Kinston, North Carolina, United States, 28501
    - Kinston Medical Specialists PA
  - Mount Airy, North Carolina, United States, 27030
    - Clinical Trials of America, LLC
  - Wilmington, North Carolina, United States, 28401
    - Trial Management Associates LLC
  - Winston-Salem, North Carolina, United States, 27157
    - Wake Forest University Baptist Medical Center
  - Winston-Salem, North Carolina, United States, 27103-3914
    - PMG Research of Winston-Salem LLC
- Ohio
  - Akron, Ohio, United States, 44333
    - Ohio Clinical Research Partners LLC
  - Centerville, Ohio, United States, 45429
    - Dr. Deepak Sarwal, MD
  - Cincinnati, Ohio, United States, 45219
    - Consultants for Clinical Research Inc.
  - Cincinnati, Ohio, United States, 45206
    - UC Health Clinical Trials Office
  - Cleveland, Ohio, United States, 44106
    - University Hospitals Case Medical Center
  - Cleveland, Ohio, United States, 44106
    - Cleveland Clinic Foundation
  - Huber Heights, Ohio, United States, 45424-3239
    - Clinical Inquest Center Ltd
  - Springfield, Ohio, United States, 45504
    - Springfield Health Care Center
- Oklahoma
  - Oklahoma City, Oklahoma, United States, 73104
    - Oklahoma University Health Sciences Center
- Oregon
  - Portland, Oregon, United States, 97239
    - Oregon Health and Science University
- Pennsylvania
  - Havertown, Pennsylvania, United States, 19083-2742
    - Main Line Gastroenterology
  - Philadelphia, Pennsylvania, United States, 19102
    - Drexel University College of Medicine
  - Philadelphia, Pennsylvania, United States, 19104
    - University of Pennsylvania School of medicine
  - State College, Pennsylvania, United States, 16803
    - Penn State University Milton S Hershey Medical Center
- Tennessee
  - Chattanooga, Tennessee, United States, 37421
    - ClinSearch LLC
  - Germantown, Tennessee, United States, 38138
    - Gastro One
  - Nashville, Tennessee, United States, 37212
    - Vanderbilt University Medical Center
- Texas
  - Arlington, Texas, United States, 76012
    - Texas Clinical Research Institute LLC
  - Arlington, Texas, United States, 76012
    - Texas Digestive Disease Consultants - Dallas
  - Dallas, Texas, United States, 75231
    - Texas Digestive Disease Consultants Dallas
  - Flower Mound, Texas, United States, 75028
    - Texas Digestive Disease Consultants - Southlake
  - Houston, Texas, United States, 77030
    - The Methodist Hospital Research Institute
  - Houston, Texas, United States, 77079
    - Houston Endoscopy and Research Center
  - Houston, Texas, United States, 77030
    - University of Texas Health Science Center at Houston
  - Houston, Texas, United States, 77004
    - Gulf Coast Research Group LLC
  - San Antonio, Texas, United States, 78229
    - Sagact Pllc
  - San Antonio, Texas, United States, 78229
    - San Antonio Military Medical Center
  - Temple, Texas, United States, 76508
    - Scott & White Medical Center
  - Tyler, Texas, United States, 75701
    - Digestive Health Specialist of Tyler
- Utah
  - Salt Lake City, Utah, United States, 84132
    - University of Utah
- Vermont
  - Colchester, Vermont, United States, 05446
    - University of Vermont
- Virginia
  - Charlottesville, Virginia, United States, 22908
    - University of Virginia
  - Charlottesville, Virginia, United States, 22911
    - Charlottesville Medical Research Center
  - Chesapeake, Virginia, United States, 23320
    - Gastroenterology Associates of Tidewater
  - Leesburg, Virginia, United States, 20176
    - Emeritas Research Group
  - Norfolk, Virginia, United States, 23502
    - Digestive and Liver Disease Specialists
  - Richmond, Virginia, United States, 23249
    - Hunter Holmes Mcguire Ctr
- Washington
  - Seattle, Washington, United States, 98104
    - Harborview Medical Center
  - Seattle, Washington, United States, 98101
    - Virginia Mason Medical Center
  - Seattle, Washington, United States, 98104
    - University of Washington School of Medicine
  - Seattle, Washington, United States, 98104
    - Swedish Medical Center
  - Vancouver, Washington, United States, 98664-4896
    - The Vancouver Clinic
- Wisconsin
  - Madison, Wisconsin, United States, 53792
    - University of Wisconsin Hospital and Clinics
  - Madison, Wisconsin, United States, 53716
    - Dean Clinic Oregon
  - Milwaukee, Wisconsin, United States, 53226-3596
    - Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Subjects must satisfy the following criteria to be enrolled in the study:

Male or female ≥ 18 years
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 7 day 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.

Exclusion Criteria:

The presence of any of the following will exclude a subject from enrollment:

Diagnosis of ulcerative colitis (UC), indeterminate colitis, ischemic colitis, microscopic colitis, radiation colitis or diverticular disease-associated colitis
Local manifestations of Crohn's Disease (CD) such as symptomatic/severe strictures, abscesses, short bowel syndrome; or other disease complications for which surgery might be indicated or could confound the evaluation of efficacy
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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Quadruple

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GED0301 160mg x 12 weeks followed by periodic 160 mg GED0301 GED-0301 160 mg once daily (QD) for 12 weeks; followed by placebo QD for 4 weeks; followed by alternating GED-0301 160 mg QD for 4 weeks and placebo QD for 4 weeks, until the the Week 52 Visit	Drug: Placebo Drug: GED-0301
Experimental: GED0301 160mg x 12 weeks followed by periodic GED0301 40mg GED-0301 160 mg once daily (QD) for 12 weeks; followed by placebo QD for 4 weeks; followed by alternating GED-0301 40 mg QD for 4 weeks and placebo QD for 4 weeks, until the Week 52 Visit	Drug: Placebo Drug: GED-0301
Experimental: GED0301 160mg x 12 weeks followed by continuous GED0301 40mg GED-0301 160 mg once daily (QD) for 12 weeks; followed by continuous GED-0301 40 mg QD, until the Week 52 Visit	Drug: GED-0301
Placebo Comparator: Placebo Placebo once daily (QD) until the Week 52 Visit	Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Percentage of Participants Who Achieved a Clinical Remission at Week 12 Time Frame: Week 12	Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score < 150. The Crohn's Disease Activity Index is used to quantify the signs and symptoms of Crohn's disease and the affect on patient's quality of life. It consists of 8 variables which include patient reported outcomes over a 7 day period and physician assessments which are scored numerically and weighted. Scores range from 0 to 600, with the most severe disease defined >450.	Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Who Achieved Clinical Remission at Week 52 Time Frame: Week 52	Clinical remission is defined as a CDAI score < 150 and is used to quantify the signs and symptoms of Crohn's disease and the effect on patient's quality of life. It consists of 8 variables which include patient reported outcomes over a 7 day period and physician assessments which are scored numerically and weighted. Scores range from 0 to 600, with the most severe disease defined >450.	Week 52
Percentage of Participants With Endoscopic Response-50 Centrally Read at Week 52 Time Frame: Week 52	An endoscopic response-50 is defined as a reduction of at least 50% compared with baseline in simple endoscopic score for Crohn's Disease (SES-CD). The SES-CD assesses the size of mucosal ulcers, the extent of ulcerated surface, the extent of affected surface, and the presence and type of narrowings. Scores range from 0 to 60 with higher scores reflecting more severe disease. The SES-CD calculations include: Ulcers scored as: 0: no aphthous (0.1-0.5 cm) large (0.5-2 cm) very large (>2 cm) Surface involved disease 0: 0% <50% 50-75% >75% Surface involved by ulcerations: 0: 0% <10% 10-30% >30% - Narrowings: 0: No Single, can be passed Multiple, can be passed Cannot be passed Grand Total = SES-CD score	Week 52
The Percentage of Participants Who Achieved a Clinical Response at Week 12 Time Frame: Week 12	A clinical response is defined as a CDAI score decrease from baseline ≥ 100 points. The CDAI is used to quantify the signs and symptoms of Crohn's disease and the effect on patient's quality of life. It consists of 8 variables which include patient reported outcomes over a 7 day period and physician assessments which are scored numerically and weighted. Scores range from 0 to 600, with the most severe disease defined >450.	Week 12
The Percentage of Participants Who Achieved a Clinical Response at Week 4 Time Frame: Week 4	A clinical response is defined as a decrease from baseline in CDAI ≥ 100 points. The Crohn's Disease Activity Index is used to quantify the signs and symptoms of Crohn's disease and the effect on patient's quality of life. It consists of 8 variables which include patient reported outcomes over a 7 day period and physician assessments which are scored numerically and weighted. Scores range from 0 to 600, with the most severe disease defined >450.	Week 4
The Percentage of Participants Who Achieved a Clinical Remission at Week 4 Time Frame: Week 4	A clinical remission is a CDAI score < 150. The Crohn's Disease Activity Index is used to quantify the signs and symptoms of Crohn's disease and the effect on patient's quality of life. It consists of 8 variables which include patient reported outcomes over a 7 day period and physician assessments which are scored numerically and weighted. Scores range from 0 to 600, with the most severe disease defined >450.	Week 4
The Percentage of Participants Who Achieved a Corticosteroid-Free Clinical Remission at Week 52 Time Frame: Week 52	The percentage of participants who were receiving oral corticosteroids for Crohn's disease, at baseline and achieved a clinical remission (CDAI score <150) at Week 52 without corticosteroids. The Crohn's Disease Activity Index is used to quantify the signs and symptoms of Crohn's disease and the effect on patient's quality of life. It consists of 8 variables which include patient reported outcomes over a 7 day period and physician assessments which are scored numerically and weighted. Scores range from 0 to 600, with the most severe disease defined >450.	Week 52
Percentage of Participants Who Achieved a Sustained Clinical Remission at Both Week 12 and 52 Time Frame: Weeks 12 and 52	For participants who achieved a sustained clinical remission at both week 12 and 52, the clinical remission is a CDAI score < 150. The Crohn's Disease Activity Index is used to quantify the signs and symptoms of Crohn's disease and the effect on patient's quality of life. It consists of 8 variables which include patient reported outcomes over a 7 day period and physician assessments which are scored numerically and weighted. Scores range from 0 to 600, with the most severe disease defined >450.	Weeks 12 and 52
Percentage of Participants With Endoscopic Response-25 Centrally Read at Week 12 Time Frame: Week 0, Week 12	An endoscopic response-25 is defined as a reduction of at least 25% compared with baseline in simple endoscopic score for Crohn's disease (SES-CD). The SES-CD assesses the size of mucosal ulcers, the extent of ulcerated surface, the extent of affected surface, and the presence and type of narrowings. Scores range from 0 to 60 with higher scores reflecting more severe disease. The SES-CD calculations include: Ulcers scored as: 0: no aphthous (0.1-0.5 cm) large (0.5-2 cm) very large (>2 cm) Surface involved disease 0: 0% <50% 50-75% >75% Surface involved by ulcerations: 0: 0% <10% 10-30% >30% - Narrowings: 0: No Single, can be passed Multiple, can be passed Cannot be passed Grand Total = SES-CD score	Week 0, Week 12
Percentage of Participants With Endoscopic Remission Centrally Read at Week 52 Time Frame: Week 52	Endoscopic remission is defined as a simple endoscopic score for Crohn's disease (SES-CD) of ≤2 at the specified timeframe. The SES-CD assesses the size of mucosal ulcers, the extent of ulcerated surface, the extent of affected surface, and the presence and type of narrowings. Scores range from 0 to 60 with higher scores reflecting more severe disease. The SES-CD calculations include: Ulcers scored as: 0: no aphthous (0.1-0.5 cm) large (0.5-2 cm) very large (>2 cm) Surface involved disease 0: 0% <50% 50-75% >75% Surface involved by ulcerations: 0: 0% <10% 10-30% >30% - Narrowings: 0: No Single, can be passed Multiple, can be passed Cannot be passed Grand Total = SES-CD score	Week 52
The Number of Participants Who Experienced Treatment Emergent Adverse Events (TEAE) From Week 0 to Week 52 Time Frame: From the first day of GED-0301 until 28 days after the last dose of investigational product (IP); maximum treatment duration was 52.6 weeks	A TEAE was defined as any adverse event (AE) occurring or worsening on or after the first treatment of GED-0301 and up to 28 days after the last GED-0301 dose or the last follow-up date, whichever occurred earlier. A serious AE = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event.	From the first day of GED-0301 until 28 days after the last dose of investigational product (IP); maximum treatment duration was 52.6 weeks
The Number of Participants Who Discontinued IP Due to an Treatment Emergent Adverse Events Time Frame: From the first day of GED-0301 until 28 days after the last dose of IP; maximum treatment duration was 52.6 weeks	A TEAE was defined as any AE occurring or worsening on or after the first dose of GED-0301 and up to 28 days after the last GED-0301 dose or the last follow-up date, whichever occurred earlier. A serious AE = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs was assessed by the investigator and based on the following scale: Mild = asymptomatic or mild symptoms; clinical or diagnostic observations only; Moderate = Symptoms cause moderate discomfort; Severe (could be non-serious or serious) = symptoms causing severe discomfort/pain.	From the first day of GED-0301 until 28 days after the last dose of IP; maximum treatment duration was 52.6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Celgene

Investigators

Study Director: Guillermo Rossiter, MD, Celgene Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 8, 2015

Primary Completion (Actual)

January 5, 2018

Study Completion (Actual)

January 5, 2018

Study Registration Dates

First Submitted

November 3, 2015

First Submitted That Met QC Criteria

November 3, 2015

First Posted (Estimate)

November 4, 2015

Study Record Updates

Last Update Posted (Actual)

August 28, 2019

Last Update Submitted That Met QC Criteria

August 20, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

GED-0301-CD-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Crohn Disease

Turku University Hospital
University of Turku

Recruiting

Investigation of VAP-1 Expression and Tissue Blood Flow by PET-MRI in Patients With Crohn's Disease (VAP-PET)

Inflammatory Bowel Diseases | Crohn Disease | Crohn Colitis | Crohn's Ileocolitis | Crohn Disease in Remission | Crohn Disease of Small Intestine

Finland
Tzaneio General Hospital

Recruiting

Laparoscopic Right Hemicolectomy for Crohn's Disease of the Terminal Ileum Utilizing the Mesenteric Excision and Exclusion

Crohn Disease (CD) | Crohn Disease of Ileum | Kono S Anastomosis | Extended Mesenteric Excision

Greece
L2 Bio, LLC
FDAMap; Akan Biosciences, Inc.

Not yet recruiting

A Double-Blind, Randomized, Placebo-Controlled Phase II Clinical Trial to Evaluate the Safety and Efficacy of L2-01 in Subjects With Crohn's Disease

Crohn&Amp;#39;s | Crohn&Amp;#39;s Disease (CD)
University Hospital, Clermont-Ferrand

Not yet recruiting

Study of Concordance Between Inflammatory Activity Assessed by Enteric MRI With and Without Intestinal Distension Product in Patients With Ileal Crohn's Disease. (CONFORT)

Crohn Disease (CD)

France
Central Hospital, Nancy, France

Not yet recruiting

Virtual hIStology of Crohn's Disease Ex-vivo Resected Anatomical Lesions (VISCERAL)

Crohn Disease (CD)

France
GLSMED Learning Health S.A.

Not yet recruiting

Prospective Risk Evaluation and Detection of Crohn's Disease in First-degree Relatives (PREDICT-CD)

Crohn Disease (CD)
University Hospital, Clermont-Ferrand

Active, not recruiting

Kinetics of Transmural Healing in Patients With Crohns Disease Treated With Risankizumab (SKYRIZI®) (SKYNETICS)

Crohn Disease (CD)

France
Assistance Publique Hopitaux De Marseille

Recruiting

Tolerance of Local Administration of Cryopreserved Autologous Stromal Vascular Fraction Combined With Micrograft for the Treatment of Refractory Ano-perineal Fistulas in Crohn's Disease (ADICROHN3)

Crohn Disease (CD)

France
Direct Biologics, LLC

Not yet recruiting

Ex Vivo Culture-expanded Adult Allogeneic Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicle Isolate Product, for the Treatment of Medically Refractory Crohn's Disease

Crohn Disease (CD)

United States
University Hospital, Grenoble

Not yet recruiting

Qualitative Exploration of Key Symptoms of Stricturing Crohn's Disease: Toward the Development of a Clinical Assessment Score. (SYMCROHNS)

Crohn Disease (CD)

France

Clinical Trials on Placebo

Galderma R&D

Completed

Effect of CD07805/47 Gel in Rosacea Flushing

Rosacea

Germany
SamA Pharmaceutical Co., Ltd

Unknown

Clinical Trials to Assess the Efficacy and Safety of HLIM

Acute Bronchitis | Acute Upper Respiratory Tract Infection

Korea, Republic of
National Institute on Drug Abuse (NIDA)

Completed

Effects of Cannabis Administration Routes on Human Performance and Pharmacokinetics

Cannabis Use

United States
AstraZeneca
Parexel; Spandauer Damm 130; 14050; Berlin, Germany

Completed

Assessment of the Safety, Tolerability and Pharmacodynamics After Administration of One Dose of AZD8601 to Male Patients With Type II Diabetes Mellitus (T2DM)

Male Subjects With Type II Diabetes (T2DM)

Germany
Akeso

Not yet recruiting

A Clinical Study of AK120 in Adolescents With Moderate-to-severe Atopic Dermatitis

Atopic Dermatitis

China
Heptares Therapeutics Limited

Completed

Pharmacokinetics of Oral Capsule in Healthy Japanese vs. Caucasian Subjects (HTL0018318)

Pharmacokinetics | Safety Issues

United Kingdom
GlaxoSmithKline

Completed

A Clinical Study Assessing Critical Errors, Training/Teaching Time, and Preference Attributes of the ELLIPTA® Dry Powder Inhaler, in Comparison to Combinations of Dry Powder Inhalers Used to Provide Triple Therapy, in Patients With Chronic Obstructive Pulmonary Disease

Pulmonary Disease, Chronic Obstructive

United Kingdom, Netherlands
Shijiazhuang Yiling Pharmaceutical Co. Ltd
Xuanwu Hospital, Beijing

Completed

Study on the Safety, Tolerance and Pharmacokinetics of Phenlarmide Tablets

Parkinson Disease

China
GlaxoSmithKline

Completed

A Study to Investigate the Safety, Tolerability and Pharmacokinetics of Oral and Intravenous GSK1322322 in Healthy Subjects

Infections, Bacterial

United States
Chong Kun Dang Pharmaceutical

Unknown

Clinical Study to Evaluate the Efficacy and Safety of CKD-348(CKD-828, D326, D337) Tablet

Hypertension | Dyslipidemias

Korea, Republic of

Efficacy and Safety Study of Mongersen (GED-0301) for the Treatment of Subjects With Active Crohn's Disease

A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Investigate the Efficacy and Safety of Mongersen (GED-0301) for the Treatment of Subjects With Active Crohn's Disease

Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Investigators

Publications and helpful links

General Publications

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimate)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Clinical Trials on Crohn Disease

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Slovenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations