Clinical trial NCT03996369: Etrasimod Versus Placebo as Induction Therapy in Moderately to Severely Active Ulcerative Colitis
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 12-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects With Moderately to Severely Active Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ulcerative Colitis
Keywords: Ulcerative Colitis
Etrasimod
APD334
Lead sponsor: Arena Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2019-06-24
Enrollment: 354
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the efficacy of etrasimod on clinical remission in participants with moderately to severely active ulcerative colitis (UC).


Eligibility criteria: Inclusion Criteria:

* Diagnosed with ulcerative colitis (UC) ≥ 3 months prior to screening
* Active UC confirmed by endoscopy

Exclusion Criteria:

* Severe extensive colitis
* Diagnosis of Crohn's disease (CD) or indeterminate colitis or the presence or history of a fistula consistent with CD
* Diagnosis of microscopic colitis, ischemic colitis, or infectious colitis

Primary outcomes:
measure: Percentage of Participants Achieving Clinical Remission
timeFrame: Week 12
Secondary outcomes:
measure: Percentage of Participants Achieving Endoscopic Improvement
timeFrame: Week 12
measure: Percentage of Participants Achieving Symptomatic Remission
timeFrame: Week 12
measure: Percentage of Participants With Mucosal Healing
timeFrame: Week 12
measure: Percentage of Participants Achieving Clinical Response
timeFrame: Week 12
measure: Percentage of Participants Achieving Endoscopic Normalization
timeFrame: Week 12
measure: Percentage of Participants Achieving Symptomatic Remission at Weeks 2, 4 and 8
timeFrame: Weeks 2, 4 and 8
measure: Percentage of Participants Achieving Complete Symptomatic Remission
timeFrame: Weeks 2, 4, 8 and 12
measure: Percentage of Participants Achieving Non-invasive Clinical Response
timeFrame: Weeks 2, 4, 8 and 12
measure: Percentage of Participants Achieving Symptomatic Response
timeFrame: Weeks 2, 4, 8 and 12
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Digestive Health Specialists of the Southeast
state: Alabama
city: Mobile
country: United States
facility: East View Medical Research, LLC
state: Alabama
city: Sun City
country: United States
facility: Arizona Digestive Health
state: Arizona
city: Lancaster
country: United States
facility: Om Research, LLC
state: California
city: Los Angeles
country: United States
facility: Entertainment Medical Group, Inc.
state: California
city: Murrieta
country: United States
facility: United Medical Doctors
state: California
city: San Diego
country: United States
facility: ACRC Studies,LLC
state: California
city: Torrance
country: United States
facility: Paradigm Clinical Research Institute
state: California
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Colorado Springs
country: United States
facility: Peak Gastroenterology Associates
state: Colorado
city: Clearwater
country: United States
facility: Gastro Florida
state: Florida
city: Clearwater
country: United States
facility: Gastro Florida
state: Florida
city: Largo
country: United States
facility: Florida Center for Gastroenterology
state: Florida
city: Miami Lakes
country: United States
facility: Life Medical Center & Research, Inc
state: Florida
city: Miami
country: United States
facility: Global Life Research Network, LLC
state: Florida
city: Naples
country: United States
facility: Gastroenterology Group of Naples
state: Florida
city: New Smyrna Beach
country: United States
facility: NSB Research
state: Florida
city: Orlando
country: United States
facility: Pediatric & Adult Research Center
state: Florida
city: Palmetto Bay
country: United States
facility: IMIC, Inc.
state: Florida
city: Port Orange
country: United States
facility: Advanced Medical Research Center
state: Florida
city: Saint Petersburg
country: United States
facility: Theia Clinical Research, LLC
state: Florida
city: Sweetwater
country: United States
facility: Lenus Research & Medical Group, LLC
state: Florida
city: Tampa
country: United States
facility: USF Department of Surgery
state: Florida
city: Tampa
country: United States
facility: GCP Clinical Research
state: Florida
city: Tampa
country: United States
facility: Guardian Angel Research Center
state: Florida
city: Zephyrhills
country: United States
facility: Florida Medical Clinic, P.A.
state: Florida
city: Atlanta
country: United States
facility: Atlanta Gastroenterology Associates
state: Georgia
city: Atlanta
country: United States
facility: Children's Center for Digestive Health Care, LLC
state: Georgia
city: Decatur
country: United States
facility: Atlanta Center for Gastroenterology, P.C.
state: Georgia
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Gurnee
country: United States
facility: Illinois Gastroenterology Group
state: Illinois
city: Baton Rouge
country: United States
facility: Texas Digestive Disease Consultants
state: Louisiana
city: Chevy Chase
country: United States
facility: Chevy Chase Clinical Research
state: Maryland
city: Columbia
country: United States
facility: Gastro Center of Maryland
state: Maryland
city: Wyoming
country: United States
facility: West Michigan Clinical Research Center
state: Michigan
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Las Vegas
country: United States
facility: Sierra Clinical Research
state: Nevada
city: Las Vegas
country: United States
facility: Las Vegas Medical Research
state: Nevada
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Mentor
country: United States
facility: Great Lakes Medical Research, LLC - Mentor
state: Ohio
city: Poland
country: United States
facility: Care Access Research
state: Ohio
city: Harrisburg
country: United States
facility: Great Lakes Medical Research, LLC - Harrisburg
state: Pennsylvania
city: Kingsport
country: United States
facility: Tri-Cities Gastroenterology
state: Tennessee
city: Knoxville
country: United States
facility: GI for Kids
state: Tennessee
city: Arlington
country: United States
facility: Texas Clinical Research Institute, LLC
state: Texas
city: Austin
country: United States
facility: The University of Texas at Austin Dell Medical School
state: Texas
city: Cypress
country: United States
facility: Texas Gastroenterology Associates, PA
state: Texas
city: Dallas
country: United States
facility: Texas Digestive Disease Consultants - Dallas
state: Texas
city: Garland
country: United States
facility: DHAT Research Institute
state: Texas
city: Houston
country: United States
facility: Baylor Gastroenterology Assoc
state: Texas
city: McAllen
country: United States
facility: Rio Grande Gastroenterology
state: Texas
city: San Marcos
country: United States
facility: Texas Digestive Disease Consultants - San Marcos
state: Texas
city: Tyler
country: United States
facility: Tyler Research Institute, LLC
state: Texas
city: Victoria
country: United States
facility: Victoria Gastroenterology
state: Texas
city: Ogden
country: United States
facility: Care Access Research LLC
state: Utah
city: Lynchburg
country: United States
facility: Blue Ridge Medical Research
state: Virginia
city: Bellevue
country: United States
facility: Washington Gastroenterology
state: Washington
city: Seattle
country: United States
facility: Virginia Mason
state: Washington
city: Huntington
country: United States
facility: Marshall University Department of Clinical Research
state: West Virginia
city: Milwaukee
country: United States
facility: Medical College of Wisconsin Clinical Trials Office
state: Wisconsin
city: Caba
country: Argentina
facility: Clinica Adventista Belgrano
state: Buenos Aires
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Mautalen Salud e Investigacion
state: Buenos Aires
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Fundación Respirar- Centro Médico Dra. De Salvo
state: Buenos Aires
city: Quilmes
country: Argentina
facility: Instituto de Investigaciones Clínicas Quilmes SRL
state: Buenos Aires
city: San Miguel de Tucuman
country: Argentina
facility: CICE Sanatorio 9 de Julio
state: Tucuman
city: Bankstown
country: Australia
facility: Bankstown-Lidcombe Hospital
state: New South Wales
city: Kingswood
country: Australia
facility: Nepean Hospital
state: New South Wales
city: Maroochydore
country: Australia
facility: Coastal Digestive Health
state: Queensland
city: North Mackay
country: Australia
facility: Coral Sea Clinical Research Institute
state: Queensland
city: Footscray
country: Australia
facility: Footscray Hospital
state: Victoria
city: Heidelberg
country: Australia
facility: Austin Health
state: Victoria
city: Parkville
country: Australia
facility: Royal Melbourne Hospital
state: Victoria
city: Liverpool
country: Australia
facility: Liverpool Hospital
city: Melbourne
country: Australia
facility: Alfred Hospital
city: Graz
country: Austria
facility: Lkh Univ. Klinikum Graz
city: Linz
country: Austria
facility: KH der Barmherzigen Brüder Linz, Interne Abteilung
city: Wien
country: Austria
facility: AKH - Medizinische Universität Wien
city: Gomel
country: Belarus
facility: Institution "Gomel Regional Clinical Hospital"
city: Grodno
country: Belarus
facility: Grodno City Clinical Hospital #4
city: Vitebsk
country: Belarus
facility: Vitebsk Regional Clinical Hospital
city: Vitebsk
country: Belarus
facility: Vitebsk Regional Clinical Specialized Center
city: Edegem
country: Belgium
facility: University Hospital Antwerp Gastroenterology and Hepatology Department
state: Antwerp
city: Bonheiden
country: Belgium
facility: Dr. Peter Bossuyt - GI Clinical Research Center
city: Gent
country: Belgium
facility: AZ Sint-Lucas & Volkskliniek
city: Gent
country: Belgium
facility: UZ Gent - Gastroenterology
city: Leuven
country: Belgium
facility: UZ Leuven Campus Gasthuisberg
city: Mechelen
country: Belgium
facility: AZ Sint-Maarten
city: Merksem
country: Belgium
facility: ZNA Jan Palfijn
city: Roeselare
country: Belgium
facility: AZ Delta
city: Plovdiv
country: Bulgaria
facility: UMHAT "Sv. Georgi", EAD
city: Ruse
country: Bulgaria
facility: UMHAT Kanev AD, Ruse
city: Sliven
country: Bulgaria
facility: Diagnostic-Consultative Center I - Sliven, EOOD
city: Sofia
country: Bulgaria
facility: ACIBADEM CITY CLINIC TOKUDA HOSPITAL EAD,Clinical Research Center
city: Sofia
country: Bulgaria
facility: DCC "Alexandrovska", EOOD
city: Sofia
country: Bulgaria
facility: UMHAT "Tsaritsa Yoanna-ISUL" EAD
city: Sofia
country: Bulgaria
facility: UMHATEM "N.I.Pirogov" EAD, Gastroenterology Department/Clinical Research center
city: Sofia
country: Bulgaria
facility: Diagnostic Consultation Center CONVEX EOOD
city: Sofia
country: Bulgaria
facility: Acibadem City Clinic University Hospital EOOD
city: Stara Zagora
country: Bulgaria
facility: Medical center "Nov Rehabilitatsionen Tsentar" EOOD
city: Veliko Tarnovo
country: Bulgaria
facility: Medical Centre MEDICA Plus OOD
city: Calgary
country: Canada
facility: Heritage Medical Research Clinic
state: Alberta
city: London
country: Canada
facility: LHSC - University Hospital
state: Ontario
city: Santiago
country: Chile
facility: Enroll SpA
city: Santiago
country: Chile
facility: Biomedica Research Group
city: Santiago
country: Chile
facility: Hospital Sotero del Rio
city: Talca
country: Chile
facility: Centro de Investigación del Maule SPA
city: Valdivia
country: Chile
facility: Clinical Research Chile SpA
city: Barranquilla
country: Colombia
facility: Clínica de la Costa Ltda.
state: Atlantico
city: Bogota
country: Colombia
facility: Clinica de la Mujer Centro de Investigaciones
state: Cundinamarca
city: Armenia
country: Colombia
facility: Hospital San Juan de Dios Fundacion Cardiomet-Cequin
state: Quindio
city: Cali
country: Colombia
facility: Clinica farallones centro de investigaciones clinicas CIC
state: Valle Del Cauca
city: Koprivnica
country: Croatia
facility: General Hospital "Dr. Tomislav Bardek" Koprivnica
city: Osijek
country: Croatia
facility: Clinical Hospital Centre Osijek
city: Zadar
country: Croatia
facility: General Hospital Zadar
city: Zagreb
country: Croatia
facility: Clinical Hospital Sveti Duh
city: Zagreb
country: Croatia
facility: University hospital centre Zagreb
city: Brno
country: Czechia
facility: Fakultni nemocnice u svate Anny v Brne
city: Hradec Kralove
country: Czechia
facility: Hepato Gastroenterologie HK s.r.o.
city: Klatovy
country: Czechia
facility: GASTRO JeKa s.r.o.
city: Olomouc
country: Czechia
facility: PreventaMed s.r.o.
city: Ostrava-Poruba
country: Czechia
facility: Fakultni nemocnice Ostrava
city: Praha
country: Czechia
facility: Axon Clinical s. r. o.
city: Praha
country: Czechia
facility: ISCARE I.V.F. a.s.
city: Praha
country: Czechia
facility: Nemocnice Na Bulovce
city: Pribram
country: Czechia
facility: Oblastni nemocnice Pribram a.s.
city: Slany
country: Czechia
facility: Nemocnice Slany
city: Aalborg
country: Denmark
facility: Aalborg University Hospital, department of medical gastroenterology
state: Nordjylland
city: Herlev
country: Denmark
facility: Herlev Hospital, Gastroenheden, 54Q2
city: Tallinn
country: Estonia
facility: Innomedica OÜ
city: Tallinn
country: Estonia
facility: West Tallinn Central Hospital
city: Tallinn
country: Estonia
facility: North Estonia Medical Centre Foundation
city: Tartu
country: Estonia
facility: Tartu University Hospital
city: Nice Cedex 3
country: France
facility: CHU Nice - Hôpital de l'Archet 2
state: Alpes Maritimes
city: Dijon
country: France
facility: CHU Dijon - Hôpital Bocage Central
state: Côte-d'Or
city: Toulouse cedex 9
country: France
facility: Hôpital Rangueil Service Gastro-entérologie et pancreatologie
state: Haute Garonne
city: Montpellier cedex 5
country: France
facility: CHU Montpellier - Hopital Saint Eloi
state: Herault
city: Rennes
country: France
facility: Chu Pontchaillou Rennes
state: Ille Et Vilaine
city: Nantes
country: France
facility: CHU Nantes Hôtel-Dieu
state: Loire Atlantique
city: Vandoeuvre les Nancy
country: France
facility: CHRU-Nancy Brabois
state: Meurthe Et Moselle
city: Lille cedex
country: France
facility: CHU Lille - Hôpital Claude Huriez
state: Nord
city: Clermont-Ferrand
country: France
facility: CHU Clermont Ferrand - Hôpital d'Estaing
state: Puy De Dome
city: Montfermeil
country: France
facility: Unite de Recherche Clinique-Urc
state: Seine Saint Denis
city: AMIENS cedex 1
country: France
facility: Chu Amiens Picardie-Sit Sud
state: Somme
city: Le Kremlin Bicêtre
country: France
facility: Groupement Hospitalier Sud - Hôpital Bicêtre
state: Val De Marne
city: Grenoble
country: France
facility: CHU Grenoble Alpes - Hôpital Michallon
city: Tbilisi
country: Georgia
facility: LTD Acad. F. Todua Medical Centre, LTD. Research Institution of Clinical Medicine
city: Tbilisi
country: Georgia
facility: LTD Israeli-Georgian medical research clinic Helsicore
city: Tbilisi
country: Georgia
facility: LLC Vivamedi
city: Tbilisi
country: Georgia
facility: LTD Institute of Clinical Cardiology
city: Tbilisi
country: Georgia
facility: JSC Infectious Diseases, AIDS and Clinical Immunology Research Center
city: Tbilisi
country: Georgia
facility: LTD Aversi Clinic
city: Tbilisi
country: Georgia
facility: LTD Central University Clinic After Academic N. Kipshidze
city: Tbilisi
country: Georgia
facility: Malkhaz Katsiashvili Multiprofile Emergency Medicine Center
city: Remscheid
country: Germany
facility: Praxis Dr. Joergensen
state: Nordrhein Westfalen
city: Bonn
country: Germany
facility: Schwerpunktpraxis Bonn
state: Rheinland Pfalz
city: Kiel
country: Germany
facility: Clinic for Internal Medicine I, University hospital Schleswig-Holstein, Campus Kiel
state: Schleswig Holstein
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Berlin - Campus Charité Mitte
city: Berlin
country: Germany
facility: Krankenhaus Waldfriede
city: Düsseldorf
country: Germany
facility: Florence-Nightingale-Krankenhaus
city: Neuss
country: Germany
facility: Johanna Etienne Krankenhaus
city: Schwerin
country: Germany
facility: Klinische Forschung Schwerin GmbH
city: Balatonfured
country: Hungary
facility: DRC Gyogyszervizsgalo Kozpont Kft.
city: Bekescsaba
country: Hungary
facility: Bekes Megyei Kozpont Korhaz Dr Rethy Pal Tagkorhaz, 4. Belgyogyaszat es 2. Gasztroenterologia
city: Budapest
country: Hungary
facility: Obudai Egeszsegugyi Centrum Kft.
city: Budapest
country: Hungary
facility: Endoexpert Egeszsegugyi Szolgaltato Kft
city: Budapest
country: Hungary
facility: Semmelweis Egyetem, II.sz. Belgyogyaszati Klinika
city: Budapest
country: Hungary
facility: Pannonia Maganorvosi Centrum
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Klinika -Gasztroenterologia
city: Gyongyos
country: Hungary
facility: Bugat Pal Korhaz
city: Szeged
country: Hungary
facility: SZTE AOK I.st dept. of Internal Medicine.
city: Szekesfehervar
country: Hungary
facility: Dept of Gastroenterology, Szent Gyorgy Hospital
city: Szekszard
country: Hungary
facility: Clinfan Ltd. Outpatient Clinic
city: Tatabanya
country: Hungary
facility: Szent Borbala Korhaz
city: Surat
country: India
facility: Nirmal Hospitals Pvt Ltd
state: Gujarat
city: Surat
country: India
facility: Surat Institute of Digestive Sciences
state: Gujarat
city: Gurgaon
country: India
facility: Fortis Memorial Research Institute
state: Haryana
city: Kochi
country: India
facility: All India Institute of Medical Sciences
state: Kerala
city: Kochi
country: India
facility: Aster Medcity,Aster DM healthcare Ltd
state: Kerala
city: Nagpur
country: India
facility: Government Medical College and Super Speciality Hospital
state: Maharashtra
city: Nagpur
country: India
facility: Midas Multispeciality Hospital Pvt.Ltd.
state: Maharashtra
city: Pune
country: India
facility: Ruby Hall Clinic
state: Maharashtra
city: Jaipur
country: India
facility: Shweta Paliwal/Vipin Kumar Jain
state: Rajasthan
city: Kanpur
country: India
facility: Postgraduate department of Medicine, GSVM Medical college
state: Uttar Pradesh
city: Afula
country: Israel
facility: HaEmek Medical Center
city: Haifa
country: Israel
facility: Bnei Zion Medical Center
city: Holon
country: Israel
facility: Wolfson Medical Center
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Jerusalem
country: Israel
facility: Hadassah University Hospital - Ein Kerem
city: Nahariya
country: Israel
facility: Galilee Medical Center
city: Petach Tikva
country: Israel
facility: Rabin Medical Center-Beilinson Campus
city: Ramat Gan
country: Israel
facility: Chaim Sheba Medical Center
city: Rehovot
country: Israel
facility: Kaplan Medical Center
city: Castellana Grotte
country: Italy
facility: Azienda Ospedaliera Saverio De Bellis
state: Bari
city: Rho
country: Italy
facility: Ospedale di Circolo
state: Milano
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
state: Milano
city: San Donato Milanese
country: Italy
facility: I.R.C.C.S Policlinico San Donato
state: Milano
city: Negrar
country: Italy
facility: Ospedale Sacro Cuore Don Calabria
state: Verona
city: Bologna
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi
city: Brescia
country: Italy
facility: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)
city: Catania
country: Italy
facility: Azienda Ospedaliera Ospedale Cannizzaro
city: Catanzaro
country: Italy
facility: Azienda Ospedaliero Universitaria Mater Domini
city: Firenze
country: Italy
facility: Azienda Ospedaliera Universitaria Careggi
city: Modena
country: Italy
facility: A.O.U. Policlinico di Modena
city: Roma
country: Italy
facility: Ospedale Sandro Pertini
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS - CEMAD
city: Torino
country: Italy
facility: A.O. Ordine Mauriziano di Torino - P.O. Ospedale Umberto I
city: Verona
country: Italy
facility: Centro Ricerche Cliniche di Verona
city: Vicenza
country: Italy
facility: Ospedale San Bortolo di Vicenza
city: Nagoya-shi
country: Japan
facility: Nagoya City University Hospital
state: Aichi
city: Nagoya
country: Japan
facility: Koujunkai Daido Clinic
state: Aichi
city: Toyohashi-shi
country: Japan
facility: Toyohashi Municipal Hospital
state: Aichi
city: Hirosaki-shi
country: Japan
facility: Hirosaki University Hospital
state: Aomori-ken
city: Hirosaki-shi
country: Japan
facility: NHO Hirosaki National Hospital
state: Aomori
city: Kashiwa-city
country: Japan
facility: Tsujinaka Hospital Kashiwanoha
state: Chiba
city: Matsuyama-shi
country: Japan
facility: Saiseikai Matsuyama Hospital
state: Ehime
city: Toon-shi
country: Japan
facility: Ehime University Hospital
state: Ehime
city: Kasuga
country: Japan
facility: Fukuoka Tokushukai Hospital
state: Fukuoka
city: Kitakyushu-shi
country: Japan
facility: JCHO Kyushu Hospital
state: Fukuoka
city: Kurume-shi
country: Japan
facility: Kurume University Hospital
state: Fukuoka
city: Fukushima-shi
country: Japan
facility: Fukushima Medical University Hospital
state: Fukushima
city: Gifu-shi
country: Japan
facility: Gifu University Hospital
state: Gifu
city: Ogaki-shi
country: Japan
facility: Ogaki Municipal Hospital
state: Gifu
city: Ota-shi
country: Japan
facility: SUBARU Health Insurance Society Ota Memorial Hospital
state: Gunma
city: Fukuyama-shi
country: Japan
facility: NHO Fukuyama Medical Center
state: Hiroshima-Ken
city: Hiroshima-shi
country: Japan
facility: Hiroshima City Hiroshima Citizens Hospital
state: Hiroshima
city: Hiroshima-shi
country: Japan
facility: Hiroshima University Hospital
state: Hiroshima
city: Asahikawa-shi
country: Japan
facility: Asahikawa City Hospital
state: Hokkaido
city: Sapporo-shi
country: Japan
facility: Tokushukai Sapporo Tokushukai Hospital
state: Hokkaido
city: Sapporo-shi
country: Japan
facility: Sapporo-Kosei General Hospital
state: Hokkaido
city: Higashi
country: Japan
facility: NHO Mito Medical Center
state: Ibaraki
city: Koga-shi
country: Japan
facility: Yuai Memorial Hospital
state: Ibaraki
city: Tsuchiura-shi
country: Japan
facility: Tsuchiura Kyodo General Hospital
state: Ibaraki
city: Kanazawa
country: Japan
facility: NHO Kanazawa Medical Center
state: Ishikawa
city: Morioka-shi
country: Japan
facility: Iwate Medical University Uchimaru Medical Center
state: Iwate
city: Takamatsu-shi
country: Japan
facility: Takamatsu Red Cross Hospital
state: Kagawa
city: Takamatsu-shi
country: Japan
facility: Kagawa Prefectural Central Hospital
state: Kagawa
city: Kagoshima-shi
country: Japan
facility: Jiaikai Izuro Imamura Hospital
state: Kagoshima
city: Kagoshima-shi
country: Japan
facility: Sameshima Hospital
state: Kagoshima
city: Kamakura-shi
country: Japan
facility: Gokeikai Ofuna Chuo Hospital
state: Kanagawa-Ken
city: Sagamihara-shi
country: Japan
facility: Sagamihara Kyodo Hospital
state: Kanagawa
city: Yokohama-shi
country: Japan
facility: NHO Yokohama Medical Center
state: Kanagawa
city: Kumamoto-shi
country: Japan
facility: Japanese Red Cross Kumamoto Hospital
state: Kumamoto
city: Kyoto-shi
country: Japan
facility: NHO Kyoto Medical Center
state: Kyoto
city: Tsu-shi
country: Japan
facility: Mie University Hospital
state: Mie-Ken
city: Yokkaichi-City
country: Japan
facility: Mie Prefectural General Medical Center
state: Mie
city: Sendai-shi
country: Japan
facility: Tohoku University Hospital
state: Miyagi
city: Sendai-shi
country: Japan
facility: JOHAS Tohoku Rosai Hospital
state: Miyagi
city: Sendai-shi
country: Japan
facility: Sendai City Hospital
state: Miyagi
city: Kashihara-city
country: Japan
facility: Nara Medical University Hospital
state: Nara
city: Niigata-shi
country: Japan
facility: Saiseikai Niigata Hospital
state: Niigata
city: Hirakata-shi
country: Japan
facility: Kansai Medical University Hospital
state: Osaka
city: Kishiwada-shi
country: Japan
facility: Tokushukai Kishiwada Tokushukai Hospital
state: Osaka
city: Osaka-shi
country: Japan
facility: Osaka City University Hospital
state: Osaka
city: Osaka-shi
country: Japan
facility: Japan Community Health care Organization Osaka Hospital
state: Osaka
city: Takatsuki-shi
country: Japan
facility: Osaka Medical College Hospital
state: Osaka
city: Saga-shi
country: Japan
facility: Saga University Hospital
state: Saga-ken
city: Saitama-shi
country: Japan
facility: JCHO Saitama Medical Center
state: Saitama-Ken
city: Otsu-shi
country: Japan
facility: Shiga University of Medical Science Hospital
state: Shiga-ken
city: Chuo -ku
country: Japan
facility: St. Luke's International Hospital
state: Tokyo
city: Itabashi-ku
country: Japan
facility: Teikyo University Hospital
state: Tokyo
city: Kodaira-shi
country: Japan
facility: Showa General Hospital
state: Tokyo
city: Minato-ku
country: Japan
facility: Jikei University Hospital
state: Tokyo
city: Minato-ku
country: Japan
facility: Kitasato University Kitasato Institute Hospital
state: Tokyo
city: Shinagawa-ku
country: Japan
facility: NTT Medical Center Tokyo
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: JCHO Tokyo Yamate Medical Center
state: Tokyo
city: Toyama-shi
country: Japan
facility: Toyama Prefectural Central Hospital
state: Toyama
city: Wakayama-shi
country: Japan
facility: Wakayama Medical University Hospital
state: Wakayama-ken
city: Fukuoka
country: Japan
facility: Fukuoka University Hospital
city: Junggu
country: Korea, Republic of
facility: Kyungpook National University Hospital
state: Daegu
city: Wonju
country: Korea, Republic of
facility: Yonsei University Wonju Severance Christian Hospital
state: Gangwon-do
city: Suwon-si
country: Korea, Republic of
facility: The Catholic University of Korea St. Vincent's Hospital
state: Gyeonggi-do
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
state: Seodaemun-gu
city: Busan
country: Korea, Republic of
facility: Dong-A University Hospital
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Chilgok Hospital
city: Beirut
country: Lebanon
facility: Saint George Hospital University Medical Center
city: Beirut
country: Lebanon
facility: American University of Beirut Medical Center
city: Beirut
country: Lebanon
facility: Hotel Dieu de France Hospital
city: Panevezys
country: Lithuania
facility: Republican Panevezys Hospital, Department of Gastroenterology
city: Vilnius
country: Lithuania
facility: UAB "Inlita", Santaros Clinical Trials Centre
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital Santaros Clinics, Center of Hepatology, Gastroenterology and Dietology
city: Irapuato
country: Mexico
facility: Consultorio Medico, InvesclinicMX
state: Guanajuato
city: Guadalajara
country: Mexico
facility: Centro de Investigacion Medico Biologica y Terapia Avanzada s.c.
state: Jalisco
city: Monterrey
country: Mexico
facility: InspirePharma S. de R. L. de C.V.
state: Nuevo León
city: Chihuahua
country: Mexico
facility: Scientia Investigación Clínica S.C.
city: Chihuahua
country: Mexico
facility: Hospital Angeles Chihuahua
city: Veracruz
country: Mexico
facility: Faicic S. de R.L. de Cv
city: Chisinau
country: Moldova, Republic of
facility: Republican Clinical Hospital, ARENSIA Exploratory Medicine
city: Chisinau
country: Moldova, Republic of
facility: Rtl Sm Srl
city: Chisinau
country: Moldova, Republic of
facility: Timofei Mosneaga Republican Clinical Hospital, Department of Gastroenterology
city: Chisinau
country: Moldova, Republic of
facility: RTL SM SRL, Institutia Medico- Sanitara Publica Spitalul Clinic, Sectia Proctologie
city: Geleen
country: Netherlands
facility: Zuyderland Medisch Centrum - Sittard-Geleen
city: Nijmegen
country: Netherlands
facility: Radboudumc
city: Tilburg
country: Netherlands
facility: ETZ Elisabeth
city: Bedzin
country: Poland
facility: Centrum Dentystyczno-Lekarskie Promedica Joanna Markiewicz
city: Białystok
country: Poland
facility: Gastromed Kralisz, Romatowski, Stachurska sp.j
city: Czestochowa
country: Poland
facility: Centrum Medyczne Pratia Czestochowa
city: Jelenia Gora
country: Poland
facility: Karkonoskie Centrum Badan Klinicznych Lexmedica
city: Kraków
country: Poland
facility: Centrum Medyczne Plejady
city: Kraków
country: Poland
facility: Topolowa Medicenter Mrozek & Wspolnicy Spolka Jawna
city: Lodz
country: Poland
facility: AmiCare Sp. z O.O. Sp.K.
city: Lodz
country: Poland
facility: IP Clinic
city: Nowy Targ
country: Poland
facility: Allmedica Badania Kliniczne Sp. z o.o. Sp.k.
city: Oswiecim
country: Poland
facility: Medicome Sp. Zo.O.
city: Poznan
country: Poland
facility: Centrum Medyczne Grunwald
city: Poznan
country: Poland
facility: SOLUMED Centrum Medyczne
city: Rzeszow
country: Poland
facility: Korczowski Bartosz, Gabinet Lekarski
city: Rzeszow
country: Poland
facility: Centrum Medyczne Medyk
city: Sopot
country: Poland
facility: ENDOSKOPIA Sp.zo.o
city: Swidnica
country: Poland
facility: DC-MED
city: Szczecin
country: Poland
facility: Twoja Przychodnia-Szczecinskie Centrum Medyczne
city: Warsaw
country: Poland
facility: Centrum Zdrowia MDM
city: Warsaw
country: Poland
facility: Centralny Szpital Kliniczny MSW w Warszawie
city: Wroclaw
country: Poland
facility: EMC INSTYTUT MEDYCZNY SA, EuroMediCare Szpital Specjalistyczny z Przychodnia - Dzial Farmacji
city: Wroclaw
country: Poland
facility: Centrum Medyczne Oporow
city: Braga
country: Portugal
facility: Hospital de Braga
city: Coimbra
country: Portugal
facility: Centro Hospitalar e Universitário de Coimbra Serviço Gastrenterologia
city: Guimarães
country: Portugal
facility: Hospital da Senhora da Oliveira Guimarães
city: Lisboa
country: Portugal
facility: Hospital da Luz Lisboa
city: Porto
country: Portugal
facility: Centro Hospitalar de São João, EPE
city: Vila Nova de Gaia
country: Portugal
facility: Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E
city: Bucharest
country: Romania
facility: S.C. Centrul Medical Unirea SRL
city: Bucuresti
country: Romania
facility: S.C MedLife SA
city: Bucuresti
country: Romania
facility: S.C Delta Health Care S.R.L, Ponderas Academic Hospital
city: Bucuresti
country: Romania
facility: S.C Euroclinic Hospital S.A
city: Bucuresti
country: Romania
facility: Spitalul Clinic Colentina
city: Bucuresti
country: Romania
facility: Institutul Clinic Fundeni
city: Bucuresti
country: Romania
facility: S.C Policlinica CCBR S.R.L
city: Cluj-Napoca
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Cluj Napoca
city: Craiova
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Craiova
city: Oradea
country: Romania
facility: S.C Pelican Impex S.R.L
city: Barnaul
country: Russian Federation
facility: LLC "Multidisciplinary Medical Clinic "Anthurium"
city: Izhevsk
country: Russian Federation
facility: LLC "Alyans Biomedical- Ural Group"
city: Kazan
country: Russian Federation
facility: Kazan State Medical University
city: Kemerovo
country: Russian Federation
facility: SAIH "Kemerovo Regional Clinical Hospital"
city: Nizhniy Novgorod
country: Russian Federation
facility: SBIH of Nizhniy Novgorod region "Nizhniy Novgorod Regional Clinical Hospital n.a. N.A. Semashko"
city: Novosibirsk
country: Russian Federation
facility: LLC Medicine Center SibNovoMed
city: Omsk
country: Russian Federation
facility: CDC "Ultramed"
city: Penza
country: Russian Federation
facility: State Budgetary Healthcare Institution "Penza Region Clinical Hospital n.a. N.N. Burdenko"
city: Saint-Peterburg
country: Russian Federation
facility: LLC SM-Clinic
city: Saint-Petersburg
country: Russian Federation
facility: Federal state Budgetary Educational Institution of Higher Education "North-Western Medical University"
city: Saint-Petersburg
country: Russian Federation
facility: FSBI of higher Education "First Saint Petersburg State Medical University n.a. I.P.Pavlov
city: Saint-Petersburg
country: Russian Federation
facility: LLC "Gastroenterological centre Expert"
city: Samara
country: Russian Federation
facility: Irkutsk State Medical Academy of Continuing Education
city: Samara
country: Russian Federation
facility: Private Educational Institution of Higher Education "Medical University "REAVIZ"
city: Samara
country: Russian Federation
facility: LLC Medical Company "Hepatologist"
city: Sestroretsk
country: Russian Federation
facility: SPb SBIH "City Hospital # 40 of Kurortnyi region"
city: Smolensk
country: Russian Federation
facility: LLC Uromed
city: Stavropol
country: Russian Federation
facility: Stavropol Regional Clinical Diagnostic Centre
city: Stavropol
country: Russian Federation
facility: LLC "Polyclinic of ultrasonography 4D"
city: Yaroslavl
country: Russian Federation
facility: City Clinical Hospital #8
city: Belgrade
country: Serbia
facility: Clinical Center " Dr Dragisa Misovic Dedinje"
city: Belgrade
country: Serbia
facility: Clinical Center of Serbia
city: Belgrade
country: Serbia
facility: Clinical Health Center Zvezdara
city: Belgrade
country: Serbia
facility: Clinical Center Bezanijska Kosa
city: Kragujevac
country: Serbia
facility: Clinical Center Kragujevac
city: Sremska Mitrovica
country: Serbia
facility: General Hospital Sremska Mitrovica
city: Vranov nad Toplou
country: Slovakia
facility: Endomed, S.R.O
state: Presov
city: Banska Bystrica
country: Slovakia
facility: Fakultna nemocnica s poliklinikou F.D. Roosevelta
city: Bardejov
country: Slovakia
facility: Alian S.R.O
city: Nitra
country: Slovakia
facility: KM Management spol. s r.o.
city: Nitra
country: Slovakia
facility: Fakultna nemocnica Nitra
city: Presov
country: Slovakia
facility: Gastro I, s.r.o.
city: Sahy
country: Slovakia
facility: Accout Center s.r.o.
city: Zilina
country: Slovakia
facility: BeneDig s.r.o.
city: Lyttelton
country: South Africa
facility: Johese Clinical Research: Unitas
state: Centurion
city: Midstream
country: South Africa
facility: Johese Clinical Research
state: Centurion
city: Lenasia
country: South Africa
facility: Lenasia Clinical Trial Centre
state: Gauteng
city: Cape Town
country: South Africa
facility: Dr JP Wright Practice
state: Western Cape
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante
city: Barcelona
country: Spain
facility: Centro Médico Teknon
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Las Palmas
country: Spain
facility: Hospital Universitario de Gran Canaria Dr. Negrin
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Baden
country: Switzerland
facility: Kantonsspital Baden
city: Bern
country: Switzerland
facility: Inselspital, Gaby Saner, Gastroenterologie, Bauchzentrum
city: Bern
country: Switzerland
facility: Berner IBD study group c/o Gastroenterologische Praxis Balsiger, Seibold &Partner
city: Bangkoknoi
country: Thailand
facility: Siriraj Hospital
state: Bangkok
city: Pathum wan
country: Thailand
facility: King Chulalongkorn Memorial Hospital
state: Bangkok
city: Ratchathewi
country: Thailand
facility: Phramongkutklao Hospital
state: Bangkok
city: Beşevler
country: Turkey
facility: Uludag University Medical Faculty
state: Yenimahalle/Ankara
city: Ankara
country: Turkey
facility: Hacettepe University Medical Faculty
city: Ankara
country: Turkey
facility: Gazi University Medical Faculty
city: Antalya
country: Turkey
facility: Antalya Training and Research Hospital
city: Kocaeli
country: Turkey
facility: Kocaeli University Research and Training Hospital
city: Trabzon
country: Turkey
facility: Karadeniz Tecnical Uni. Med. Fac.
city: Dnipro
country: Ukraine
facility: I.I.Mechnykov Dnipropetrovsk Regional Clinical Hospital
city: Ivano-Frankivsk
country: Ukraine
facility: Department of Propaedeutics of Internal Medicine Ivano-Frankivsk National Medical University
city: Ivano-Frankivsk
country: Ukraine
facility: Municipal non-profit enterprise Regional Clinical Hospital of Ivano-Frankivsk Regional Council, Ga
city: Kharkiv
country: Ukraine
facility: CNE Prof. O.O. Shalimov Kharkiv City Clinical Hospital #2 of KCC
city: Kharkiv
country: Ukraine
facility: Communal Non-commercial Enterprise of Kharkiv Regional Council Regional Clinical Hospital
city: Kharkiv
country: Ukraine
facility: Communal Non-Commercial Enterprise City Clinical Hospital #13 of Kharkiv City Council
city: Kherson
country: Ukraine
facility: Communal Noncommercial Enterprise Ye.Ye. Karabelesh Kherson City Clinical Hospital of Kherson City
city: Kremenchuk
country: Ukraine
facility: Kremenchuk first city hospital n.a. O.T. Bohaievskyi
city: Kyiv
country: Ukraine
facility: Kyiv CCH #18 Dept of Proctology O. O. Bogomolets NMU
city: Kyiv
country: Ukraine
facility: Kyiv City Clinical Hospital N 1
city: Lviv
country: Ukraine
facility: Communal Non-Commercial Enterprise Lviv Clinical Hospital of Emergency Medical Care
city: Odesa
country: Ukraine
facility: Odesa regional clinical hospital, regional center of gastroenterology, surgical department
city: Uzhgorod
country: Ukraine
facility: A. Novak Transcarpathian Regional Clinical Hospital
city: Vinnytsia
country: Ukraine
facility: Medical Clinical Investigational Center of Medical Center Health Clinic LLC
city: Vinnytsia
country: Ukraine
facility: M.I. Pyrogov VRCH Dept of Gastroenterology M.I. Pyrogov VNMU
city: Vinnytsia
country: Ukraine
facility: SRI of Invalid Rehabilitation (EST Complex) of Vinnytsia M.I.Pyrogov NMU MOHU
city: London
country: United Kingdom
facility: Whipps Cross University Hospital
state: Greater London
city: London
country: United Kingdom
facility: Guy's and Saint Thomas NHS Foundation Trust
state: Greater London
city: Norwich
country: United Kingdom
facility: Norfolk and Norwich University Hospital
state: Norfolk
city: Yeovil
country: United Kingdom
facility: Yeovil District Hospital
state: Somerset
Study officials:
affiliation: Arena Pharmaceuticals
name: Arena CT.gov Administrator
role: STUDY_DIRECTOR
References: