A Study of JNJ-77242113 in Participants With Moderately to Severely Active Ulcerative Colitis (ANTHEM-UC)

Last Updated   May 23, 2024 - 21:06

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OVERVIEW

  • Gender
    all
  • Age
    18+ years
  • Phase
    phase 2
    The drug or treatment is given to a larger group of people to see if it is effective and to better understand its safety.
  • Sites
    177 sites
  • Status
    Recruiting

SUMMARY

The purpose of this study is to evaluate the safety and effectiveness of JNJ-77242113 compared with placebo in participants with moderately to severely active ulcerative colitis.

CONDITIONS

  • Colitis, Ulcerative

ELIGIBILITY

Inclusion Criteria:

* Signed informed consent form 18 years of age or older

* Documented diagnosis of ulcerative colitis (UC) of at least 12 weeks prior to screening

* Moderately to severely active UC as per the modified Mayo score

* Demonstrated inadequate response to or intolerance of conventional therapy and/or advanced therapy as defined in the protocol

Exclusion Criteria:

* Participants with current or prior diagnosis of fulminant colitis and/or toxic megacolon

* UC limited to rectum only or to less than (<) 15 centimeters (cm) of colon

* Presence of a stoma

* Presence or history of fistula

* History of extensive colonic resection (example, <30 cm of colon remaining)

* Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, Crohn's colitis or clinical findings suggestive of Crohn's disease

DETAILS

LOCATIONS

Locations in:
United States, United Kingdom, Turkey, Spain, South Korea, Romania, Poland, Malaysia, Japan, Italy, India, Hungary, Germany, France, Czechia, China, Canada, Brazil, Belgium, Australia, Argentina
Country (21) City or Province (177) Status
United States Atlanta, GA Atlanta Gastroenterology Associates
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United States Baltimore, MD Mercy Medical Center
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United States Bellevue, WA Washington Gastroenterology, PLLC
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United States Chapel Hill, NC University North Carolina at Chapel Hill
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United States Charlotte, NC Atrium Health
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United States Charlotte, NC Charlotte Gastroenterology and Hepatology, PLLC
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United States Chesapeake, VA Gastroenterology Associates of Tidewater
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United States Colorado Springs, CO Peak Gastroenterology Associates
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United States Garland, TX DHAT Research Institute
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United States Georgetown, TX Amel Med LLC Research
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United States Greenville, SC Gastroenterology Associates P.A.
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United States Humble, TX Accurate Clinical Research, Inc.
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United States Jefferson, LA Ochsner Medical Center
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United States Kissimmee, FL I.H.S. Health. LLC
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United States Lubbock, TX Caprock Gastro Research
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United States Marrero, LA Tandem Clinical Research
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United States New Albany, IN Gastroenterology of Southern Indiana
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United States New York, NY New York Gastroenterology Associates
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United States Newport Beach, CA Hoag Memorial Hospital
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United States North Massapequa, NY DiGiovanna Institute for Medical Education & Research
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United States Ogden, UT Care Access Research, Ogden
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United States Oklahoma City, OK Digestive Disease Specialists Inc
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United States Orange, CA Clinnova Research
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United States Orlando, FL Endoscopic Research Inc
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United States Rochester, MN Mayo Clinic Rochester
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United States San Antonio, TX Southern Star Research Institute, LLC
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United States San Diego, CA Medical Associates Research Group, Inc.
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United States Tacoma, WA Washington Gastroenterology, PLLC
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United States Tampa, FL GCP Clinical Research
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United States Topeka, KS Cotton O'Neil Digestive Health Center
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United States Tyler, TX Tyler Research Institute, LLC
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United States Westlake, OH Northshore Gastroenterology Research, LLC
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United Kingdom Bury Fairfield General Hospital
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United Kingdom Cambridge, CAM Addenbrookes Hospital
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United Kingdom London Barts Health NHS Trust
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United Kingdom London Guys St Thomas Hospital
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United Kingdom London King s College Hospital
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United Kingdom London St George's University Hospital NHS Foundation Trust
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United Kingdom Oxford, OXF Oxford University Hospitals NHS Foundation Trust
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United Kingdom Prescot, MSY Whiston Hospital
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United Kingdom Southampton Southampton University Hospital
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Turkey Ankara Gazi University Medical Faculty
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Turkey Bursa Uludag Universitesi Tıp Fakultesi Hastanesi
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Turkey Izmir Ege Universitesi Tip Fakultesi
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Turkey Mersin Mersin University Medical Faculty
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Spain Alcorcon, MD Hosp. Univ. Fundacion Alcorcon
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Spain Ferrol Hosp. Arquitecto Marcide
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Spain Gijon, AS Hosp. de Cabuenes
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Spain Madrid, MD Hosp. Univ. La Paz
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Spain Majadahonda, MD Hosp. Univ. Pta. de Hierro Majadahonda
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Spain Santiago de Compostela Hosp. Clinico Univ. de Santiago
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Spain Sevilla Hosp. Ntra. Sra. de Valme
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Spain Sevilla Hosp. Virgen Macarena
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Spain Valencia, VC Hosp. Clinico Univ. de Valencia
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Spain Valencia, VC Hosp. Univ. I Politecni La Fe
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Spain Vigo, PO Hosp. Alvaro Cunqueiro
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South Korea Busan Inje University Haeundae Paik Hospital
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South Korea Daegu Yeungnam University Hospital
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South Korea Seoul Asan Medical Center
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South Korea Seoul Kangbuk Samsung Hospital
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South Korea Seoul Samsung Medical Center
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South Korea Seoul Seoul National University Hospital
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South Korea Suwon-si, 41 The Catholic university of Korea, St. Vincent's Hospital
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Romania Bucuresti S C Delta Health Care S R L
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Romania Bucuresti Spital Memorial
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Romania Cluj-Napoca Digenio - Centrul Medical de Gastroenterologie, Hepatologie si Endoscopie Digestiva
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Romania Ploiesti, PH Centrul Medical Valahia
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Poland Bydgoszcz Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy
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Poland Chojnice Centrum Medyczne Lukamed
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Poland Krakow Centrum Medyczne Plejady
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Poland Rzeszow Centrum Medyczne Medyk
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Poland Szczecin Sonomed Sp. z o.o.
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Poland Torun GASTROMED Sp. z o.o.
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Poland Warszawa Bodyclinic Sp. z o.o. sp. k
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Poland Warszawa Centralny Szpital Kliniczny Mswia
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Poland Warszawa Medical Network Spolka z o.o. WIP Warsaw IBD Point Profesor Kierkus
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Poland Wroclaw Centrum Medyczne Oporow
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Poland Wroclaw EMC Instytut Medyczny SA
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Poland Wroclaw Melita Medical Sp. z o.o.
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Malaysia Johor Bahru, JH Hospital Sultanah Aminah
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Malaysia Kajang, SL Sultan Idris Shah Hospital
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Malaysia Kuala Lumpur University Malaya Medical Centre
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Japan Fujiidera-shi, 27 Sai Clinic, Gastrointestinal and Protology Divisions
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Japan Hamamatsu Hamamatsu University Hospital
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Japan Kagoshima Kagoshima IBD Gastroenterology Clinic
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Japan Kashiwa Tsujinaka Hospital Kashiwanoha
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Japan Kobe, 28 Aoyama Naika Clinic
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Japan Osaka, 27 Japanese Red Cross Osaka Hospital
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Japan Osaka, 27 Kinshukai Infusion Clinic
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Japan Sakura Toho University Sakura Medical Center
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Japan Sapporo, 01 Sapporo Higashi Tokushukai Hospital
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Japan Sapporo, 01 Sapporo Tokushukai Hospital
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Japan Shimizu National Hospital Organization Shizuoka Medical Center
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Japan Sumida ku, 13 Tokyo Metropolitan Bokutoh Hospital
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Japan Tsu Mie University Hospital
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Japan Yokohama, 14 Yokohama City University Medical Center
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Italy Milano Fondazione IRCCS Ca Granda Ospedale Policlinico Di Milano
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Italy Milano Ospedale San Raffaele di Milano
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Italy Negrar Di Valpolicella Ospedale Sacro Cuore Don Calabria
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Italy Roma Azienda Ospedaliera San Camillo - Roma
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Italy Roma Fondazione Policlinico Universitario A Gemelli IRCCS
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Italy Rozzano Istituto Clinico Humanitas
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Italy San Giovanni Rotondo Casa Sollievo della Sofferenza, IRCCS
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India Jaipur, RJ S. R. Kalla Memorial General Hospital
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India Nagpur, MH Midas Multispeciality Hospital
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India New Delhi, DL Govind Ballabh Pant Hospital
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India Surat, GJ SIDS Hospital & Research Centre
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Hungary Budapest Pannónia Magánorvosi Centrum Kft
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Hungary Budapest Semmelweis Egyetem
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Hungary Budapest Semmelweis Egyetem
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Hungary Debrecen Debreceni Egyetem Gasztroenterologiai Klinika
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Hungary Debrecen Vasutegeszsegugyi Nonprofit Kozhasznu Kft.
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Hungary Gyongyos Clinexpert Kft
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Germany Augsburg Klinikum Augsburg
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Germany Berlin, BE Krankenhaus Waldfriede Mitte
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Germany Dresden, SN Universitaetsklinikum Carl Gustav Carus TU Dresden
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Germany Hannover Medizinische Hochschule Hannover
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Germany Kiel, SH Universitatsklinikum Schleswig Holstein Kiel
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Germany Leipzig Eugastro GmbH
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Germany Lueneburg, NI Staedtisches Klinikum Lueneburg
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Germany Minden Gastroenterologische Gemeinschaftspraxis Minden
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France Besancon Cedex CHRU Besancon Hopital Jean Minjoz
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France Creteil APHP - Hopital Henri Mondor
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France Lille CHRU de Lille Hopital Claude Huriez
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France Neuilly-sur-Seine Clinique Ambroise Pare
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France Nice CHU de Nice Hopital de l Archet
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France Nimes Cedex CHU Nimes Hopital Caremeau
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France Paris APHP - Hopital Bichat - Claude Bernard
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France Pierre Benite Hospices Civils de Lyon CHU Lyon Sud
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France Saint Priest en Jarez CHU Saint Etienne Hopital Nord
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France Toulouse CHU Toulouse - Hopital de Rangueil
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France Vandœuvre-les-Nancy CHU de Nancy_ Hopital Brabois
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Czechia Ceske Budejovice Nemocnice Ceske Budejovice
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Czechia Hradec Kralova Gastroenterologie, s.r.o., Hradec Kralove
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Czechia Hradec Kralove Hepato-gastroenterologie HK, s.r.o.
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Czechia Praha ISCARE a.s.
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Czechia Slany Nemocnice Slany
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China Changsha The second Xiangya Hospital of Central South University
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China Chongqing, 97 Chongqing General Hospital
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China Guangzhou The First Affiliated Hospital Sun Yat sen University
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China Guangzhou The Sixth Affiliated Hospital Sun Yat sen University
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China Hangzhou Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
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China Jinan Qilu Hospital of Shandong University
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China Lan Zhou Lanzhou University Second Hospital
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China Nan Jing Shi Nanjing Drum Tower Hospital
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China Shen Yang Shi Shengjing Hospital of China Medical University
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China Wuhan Union Hospital Tongji Medical College of Huazhong University of Science and Technology
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China Wuxi Wuxi People s Hospital
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China Xi'An The Second Affiliated Hospital of Air Force Medical University - Tangdu Hospital
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Canada Barrie, ON Barrie GI Associates
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Canada Edmonton, AB Gastroenterology and Internal Medicine Research Institute (GIRI)
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Canada London, ON London Health Sciences Centre
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Canada Montréal, QC Centre Hospitalier de l'Universite de Montreal
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Canada Oakville, ON ABP Research Services Corp.
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Brazil Botucatu UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu
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Brazil Brasília L2IP Instituto de Pesquisas Clinicas
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Brazil Curitiba, PR CDC - Centro Digestivo de Curitiba
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Brazil Porto Alegre Hospital de Clinicas de Porto Alegre - Hospital de Clinicas
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Brazil Santo Andre, SP Pesquisare Saude
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Brazil Sao Paulo, SP BR TRIALS-Ensaios Clinicos e Consultoria Ltda
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Brazil Sao Paulo, SP Instituto D Or de Pesquisa e Ensino
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Brazil Votuporanga, SP INTEGRAL Pesquisa e Ensino
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Belgium Brussels, BRU CHU Saint-Pierre
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Belgium Gent AZ Sint-Lucas
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Belgium Gent Ghent University Hospital
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Belgium Leuven Universitair Ziekenhuis Leuven
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Belgium Liege Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman
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Belgium Sint-Niklaas Vitaz
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Australia Birtinya, QLD Sunshine Coast University Hospital
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Australia Blacktown, NSW Blacktown Hospital
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Australia Concord, NSW Concord Repatriation General Hospital
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Australia Wollongong, NSW Wollongong Private Hospital
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Argentina Buenos Aires, B Cer Instituto Medico
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Argentina Buenos Aires, B Gedyt - Consultorios Gastroenterologia
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Argentina Ciudad Autonoma de Buenos Aires, B CIPREC
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Argentina Rosario Hospital Provincial del Centenario
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Argentina San Miguel de Tucuman Sanatorio 9 de Julio
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