Clinical trial NCT03945188: Etrasimod Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-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: 2019-05-10
Enrollment: 433
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 determine whether oral etrasimod is a safe and effective treatment for moderately to severely active ulcerative colitis.


Eligibility criteria: Inclusion criteria:

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

Exclusion criteria:

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

Primary outcomes:
measure: Percentage of Participants Achieving Clinical Remission at Week 12
timeFrame: At Week 12
measure: Percentage of Participants Achieving Clinical Remission at Week 52
timeFrame: At Week 52
Secondary outcomes:
measure: Percentage of Participants Achieving Endoscopic Improvement at Week 12
timeFrame: At Week 12
measure: Percentage of Participants Achieving Endoscopic Improvement at Week 52
timeFrame: At Week 52
measure: Percentage of Participants Achieving Symptomatic Remission at Week 12
timeFrame: At Week 12
measure: Percentage of Participants Achieving Symptomatic Remission at Week 52
timeFrame: At Week 52
measure: Percentage of Participants With Mucosal Healing at Week 12
timeFrame: At Week 12
measure: Percentage of Participants With Mucosal Healing at Week 52
timeFrame: At Week 52
measure: Percentage of Participants Achieving Corticosteroid-free Clinical Remission at Week 52
timeFrame: At Week 52
measure: Percentage of Participants Achieving Sustained Clinical Remission at Both Weeks 12 and 52
timeFrame: At Weeks 12 and 52
measure: Percentage of Participants Achieving Clinical Response at Week 12
timeFrame: At Week 12
measure: Percentage of Participants Achieving Clinical Response at Week 52
timeFrame: At Week 52
measure: Percentage of Participants Achieving Clinical Response at Both Weeks 12 and 52
timeFrame: At Weeks 12 and 52
measure: Percentage of Participants With Mucosal Healing at Both Weeks 12 and 52
timeFrame: At Weeks 12 and 52
measure: Percentage of Participants Achieving Endoscopic Normalization at Week 12
timeFrame: At Week 12
measure: Percentage of Participants Achieving Endoscopic Normalization at Week 52
timeFrame: At Week 52
measure: Percentage of Participants Achieving Endoscopic Normalization at Both Weeks 12 and 52
timeFrame: At Weeks 12 and 52
measure: Percentage of Participants Achieving Symptomatic Remission by Study Visit
timeFrame: At Weeks 2, 4, 8, 16, 20, 24, 32, 40, and 48
measure: Percentage of Participants Achieving Complete Symptomatic Remission by Study Visit
timeFrame: At Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48 and 52
measure: Percentage of Participants Achieving Non-invasive Clinical Response by Study Visit
timeFrame: At Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
measure: Percentage of Participants Achieving Symptomatic Response by Study Visit
timeFrame: At Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
measure: Percentage of Participants Achieving 4-week Corticosteroid-free Clinical Remission at Week 52 Among Participants Receiving Corticosteroids at Baseline
timeFrame: At Week 52
measure: Percentage of Participants Achieving Clinical Remission at Week 52 Among Participants in Clinical Response at Week 12
timeFrame: At Week 52
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Digestive Health Specialists of the Southeast
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: San Diego Gastroenterology Medical Associates
state: California
city: San Diego
country: United States
facility: ACRC Studies, LLC
state: California
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: West Central Gastroenterology d/b/a Gastro Florida
state: Florida
city: Clearwater
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: Javier Sobrado, MD
state: Florida
city: Naples
country: United States
facility: Gastroenterology Group of Naples
state: Florida
city: Naples
country: United States
facility: Office of Dr Meckstroth
state: Florida
city: New Smyrna Beach
country: United States
facility: NSB Research
state: Florida
city: Ocala
country: United States
facility: Sarkis Clinical Trials - Parent
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: Saint Petersburg
country: United States
facility: Advanced Research Institute, Inc.
state: Florida
city: Sweetwater
country: United States
facility: Lenus Research & Medical Group
state: Florida
city: Tampa
country: United States
facility: USF Physicians Group
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: Weeki Wachee
country: United States
facility: ASCLEPES Research Centers, P.C.
state: Florida
city: Zephyrhills
country: United States
facility: Florida Medical Clinic, P.A.
state: Florida
city: Atlanta
country: United States
facility: Atlanta Gastroenterology Associates LLC
state: Georgia
city: Atlanta
country: United States
facility: Atlanta Gastroenterology Associates
state: Georgia
city: Decatur
country: United States
facility: Atlanta Center for Gastroenterology, P.C.
state: Georgia
city: Gurnee
country: United States
facility: Illinois Gastroenterology Group
state: Illinois
city: Moline
country: United States
facility: Gen1 Research
state: Illinois
city: Baton Rouge
country: United States
facility: Texas Digestive Disease Consultants
state: Louisiana
city: Houma
country: United States
facility: CroNOLA
state: Louisiana
city: Lake Charles
country: United States
facility: Clinical Trials of SW Louisiana, LLC
state: Louisiana
city: Metairie
country: United States
facility: Clinical Trials Management, LLC
state: Louisiana
city: Chevy Chase
country: United States
facility: Chevy Chase Clinical Research
state: Maryland
city: Flint
country: United States
facility: Flint Clinical Research
state: Michigan
city: West Bloomfield
country: United States
facility: Robert Ferguson MD
state: Michigan
city: Flowood
country: United States
facility: Gastrointestinal Associates
state: Mississippi
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: Durham
country: United States
facility: Duke University Medical Center GI Clinical Research Unit
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
state: Ohio
city: Poland
country: United States
facility: Care Access Research
state: Ohio
city: Oklahoma City
country: United States
facility: Digestive Disease Specialists, Inc.
state: Oklahoma
city: Harrisburg
country: United States
facility: Great Lakes Medical Research, LLC
state: Pennsylvania
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: Baytown
country: United States
facility: Coastal Medical Group
state: Texas
city: Cypress
country: United States
facility: Texas Gastroenterology Associates, PA
state: Texas
city: Dallas
country: United States
facility: Texas Digestive Disease Consultants
state: Texas
city: Garland
country: United States
facility: Digestive Health Associates of Texas
state: Texas
city: Houston
country: United States
facility: CliniCore Texas
state: Texas
city: Houston
country: United States
facility: Baylor Gastroenterology Assoc
state: Texas
city: Houston
country: United States
facility: Biopharma Informatic, Inc. Research Center
state: Texas
city: McAllen
country: United States
facility: Rio Grande Gastroenterology
state: Texas
city: Pasadena
country: United States
facility: Biopharma Informatic, Inc. Research Center
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: 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 Medical Center
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: 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 Pty Ltd
state: Queensland
city: North Mackay
country: Australia
facility: Coral Sea Clinical Research Institute
state: Queensland
city: Heidelberg
country: Australia
facility: Austin Health Gastroenterology Department
state: Victoria
city: Parkville
country: Australia
facility: Royal Melbourne Hospital
state: Victoria
city: Linz
country: Austria
facility: KH der Barmherzigen Brüder Linz
city: Wien
country: Austria
facility: AKH - Medizinische Universität Wien
city: Wien
country: Austria
facility: Wilhelminenspital der Stadt Wien
city: Gomel
country: Belarus
facility: Institution "Gomel Regional Clinical Hospital"
city: Grodno
country: Belarus
facility: Grodno City Clinical Hospital #4
city: Minsk
country: Belarus
facility: Health Care Institution "10th City Clinical Hospital"
city: Vitebsk
country: Belarus
facility: Vitebsk Regional Clinical Hospital
city: Vitebsk
country: Belarus
facility: Vitebsk Regional Clinical Specialized Center
city: Gent
country: Belgium
facility: AZ Sint-Lucas & Volkskliniek
city: Gent
country: Belgium
facility: UZ Gent Gastroenterology
city: Merksem
country: Belgium
facility: ZNA Jan Palfijn
city: Roeselare
country: Belgium
facility: AZ Delta
city: Pleven
country: Bulgaria
facility: Medical center Medconsult Pleven OOD
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 "Sv. Ivan Rilski", EAD,Clinic of gastroenterology
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, next to the chimney
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: Toronto
country: Canada
facility: Mount Sinai 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: 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 Dubrava
city: Zagreb
country: Croatia
facility: Clinical Hospital Sveti Duh
city: Zagreb
country: Croatia
facility: Polyclinic Bonifarm
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: ISCARE I.V.F. a.s.
city: Praha
country: Czechia
facility: Nemocnice Na Bulovce
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
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: Nice Cedex 3
country: France
facility: CHU Nice - Hôpital de l'Archet 2
state: Alpes Maritimes
city: Montpellier cedex 5
country: France
facility: CHU Montpellier - HOPITAL SAINT-ELOI
state: Herault
city: Nantes
country: France
facility: CHU Nantes Hôtel-Dieu
state: Loire Atlantique
city: Grenoble
country: France
facility: CHU Grenoble Alpes - Hôpital Michallon
city: Vandoeuvre-lès-Nancy
country: France
facility: CHRU-Nancy Brabois
city: Tbilisi
country: Georgia
facility: LTD Acad. F. Todua Medical Center - LTD Research Institute 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: 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: Pannonia Maganorvosi Centrum
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: 1th Dept of Gastroenterology, Szent Gyorgy Hospital
city: Szekszard
country: Hungary
facility: Clinfan Ltd. Outpatient Clinic
city: Tatabanya
country: Hungary
facility: Szent Borbala Korhaz
city: Hyderabad
country: India
facility: Asian Institute of Gastroenterology
state: Andhra Pradesh
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: Aster Medcity,Aster DM healthcare Ltd
state: Kerala
city: Nagpur
country: India
facility: Midas Multispeciality Hospital-Nagpur
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
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: 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: Brescia
country: Italy
facility: Spedali Civili di Brescia, U.O. Gastroenterologia
city: Catania
country: Italy
facility: Azienda Ospedaliera Ospedale Cannizzaro
city: Catanzaro
country: Italy
facility: Magna Graecia University
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: Vicenza
country: Italy
facility: Ospedale San Bortolo di Vicenza
city: Junggu
country: Korea, Republic of
facility: Kyungpook National University Hospital
state: Daegu
city: Wonju
country: Korea, Republic of
facility: 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: Riga
country: Latvia
facility: P. Stradins Clinical University Hospital
city: Beirut
country: Lebanon
facility: Saint George University Hospital Medical Center
city: Kaunas
country: Lithuania
facility: Kaunas Clinical Hospital
city: Klaipeda
country: Lithuania
facility: Klaipeda University Hospital, Department of Gastroenterology
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: 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: Clinical Hospital of the Ministry of Health, Labor and Social Protection
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: 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: 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: Lodz
country: Poland
facility: Med-Gastr Przychodnia Specjalistyczna
city: Nowy Targ
country: Poland
facility: Allmedica Badania Kliniczne Sp. z o.o. Sp.k.
city: Nowy Targ
country: Poland
facility: Medicenter Nowy Targ
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: Centrum Medyczne Medyk
city: Sopot
country: Poland
facility: ENDOSKOPIA Sp.zo.o
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: Wroclaw
country: Poland
facility: Jerzy Rozciecha- Lexmedica
city: Braga
country: Portugal
facility: Hospital de Braga
city: Coimbra
country: Portugal
facility: Centro Hospitalar e Universitário de Coimbra Serviço Gastrenterologia
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: Dr. Carol Davila Central University Emergency Military Hospital
city: Bucharest
country: Romania
facility: Centrul Medical Unirea srl
city: Bucuresti
country: Romania
facility: S.C Policlinica CCBR S.R.L
city: Bucuresti
country: Romania
facility: S.C MedLife SA
city: Bucuresti
country: Romania
facility: Delta Health Care srl
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: Cluj-Napoca
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Cluj Napoca
city: Craiova
country: Romania
facility: Spitalul Clinic Judetean de Urgenta
city: Oradea
country: Romania
facility: Cabinet Medical Dr. Fratila S.R.L
city: Oradea
country: Romania
facility: S.C Pelican Impex S.R.L
city: Barnaul
country: Russian Federation
facility: LLC "Multidisciplinary Medical Clinic "Anthurium"
city: Irkutsk
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 Petersburg
country: Russian Federation
facility: LLC "Medinet"
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: LLC SM-Clinic
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: 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: 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 Banska Bystrica
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: Nove Zamky
country: Slovakia
facility: GASTROENTEROLOG, s.r.o.
city: Presov
country: Slovakia
facility: Gastro I, s.r.o.
city: Sahy
country: Slovakia
facility: Accout Center 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: Johannesburg
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: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Bangkoknoi
country: Thailand
facility: Faculty of Medicine Siriraj Hospital
state: Bangkok
city: Pathum Wan
country: Thailand
facility: Supaporn Lertkawinanan
state: Bangkok
city: Ratchathewi
country: Thailand
facility: Phramongkutklao Hospital
state: Bangkok
city: Chiang Mai
country: Thailand
facility: Ms. Arawan Larplertsakul
city: Beşevler
country: Turkey
facility: Uludag University Medical Faculty
state: Yenimahalle / Ankara
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: 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: National Military Medical Clinical Center Main Military Clinical Hospital
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: Zaporizhzhia
country: Ukraine
facility: Communal Institution City Clinical Hospital #6, Department of Gastroenterology
city: London
country: United Kingdom
facility: Barts Health NHS Trust - Whipps Cross University Hospital
state: Greater London
city: London
country: United Kingdom
facility: Guys and St Thomas NHS Foundation Trust
state: Greater London
city: Norwich
country: United Kingdom
facility: Norfolk and Norwich University Hospitals NHS Foundation Trust
state: Norfolk
city: Yeovil
country: United Kingdom
facility: Yeovil Hospital NHS Foundation Trust
state: Somerset
city: Belfast
country: United Kingdom
facility: Belfast Health and Social Care Trust Royal Victoria Hospital
city: Hemel Hempstead
country: United Kingdom
facility: West Hertfordshire Hospitals NHS Trust Hemel Hempstead General Hospital
Study officials:
affiliation: Arena Pharmaceuticals
name: Arena CT.gov Administrator
role: STUDY_DIRECTOR
References: