Clinical trial NCT04607837: Etrasimod Versus Placebo for the Treatment of Moderately Active Ulcerative Colitis
Official title: A Randomized, Double Blind, Placebo Controlled, 52 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects With Moderately Active Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ulcerative Colitis
Keywords: Ulcerative colitis
Etrasimod
APD334
UC
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Arena is a wholly owned subsidiary of Pfizer
First posted: 2020-10-29
Enrollment: 234
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: 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 active ulcerative colitis in adult participants.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with Ulcerative Colitis (UC) ≥ 3 months prior to screening
* Active UC confirmed by endoscopy
* Moderately active UC defined as a modified Mayo score of 4 to 6 and an endoscopic score ≥ 2 and rectal bleeding score ≥ 1
* Received a surveillance colonoscopy within 12 months before baseline

Exclusion Criteria:

* Severe extensive colitis
* Diagnosis of Crohn's disease or indeterminate colitis or the presence or history of a fistula consistent with Crohn's disease
* Diagnosis of microscopic colitis, ischemic colitis, or infectious colitis
* Hospitalization for exacerbation of UC requiring intravenous steroids within 12 weeks prior to or after screening

Primary outcomes:
measure: Proportion of Participants Achieving Clinical Remission
timeFrame: Week 52
Secondary outcomes:
measure: Proportion of Participants Achieving Clinical Remission
timeFrame: Week 12
measure: Proportion of Participants Achieving Endoscopic Improvement
timeFrame: Week 52
measure: Proportion of Participants Achieving Symptomatic Remission
timeFrame: Week 52
measure: Proportion of Participants Achieving Mucosal Healing
timeFrame: Week 52
measure: Proportion of participants achieving clinical remission at both Weeks 12 and 52
timeFrame: Week 12 and Week 52
measure: Proportion of Participants achieving clinical remission at Week 52 and who had not been receiving corticosteroids for ≥ 12 weeks immediately prior to Week 52
timeFrame: Week 52
measure: Number and Severity of Adverse Events
timeFrame: Up to approximately 56 weeks (52-Week Treatment Period and 4-Week Follow-Up Period)
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Center for Digestive Health (Colonoscopy Location)
state: Alabama
city: Dothan
country: United States
facility: Digestive Health Specialists
state: Alabama
city: Dothan
country: United States
facility: Dothan Eyecare-Dr. Brent McKinley (OCT Location)
state: Alabama
city: Dothan
country: United States
facility: Pulmonary Associates (Secondary PFT Location)
state: Alabama
city: Dothan
country: United States
facility: Flowers Hospital (PFT Location)
state: Alabama
city: Peoria
country: United States
facility: Arizona Retina Institute/ Phoenix Retina Associates(OCT)
state: Arizona
city: Peoria
country: United States
facility: SimonMed Imaging (Imaging)
state: Arizona
city: Sun City
country: United States
facility: Sun City Endoscopy (Endoscopy)
state: Arizona
city: El Cajon
country: United States
facility: Euclid Endoscopy Center-El Cajon (Endoscopy procedure only)
state: California
city: Irvine
country: United States
facility: Center for Clinical Research (CCR)
state: California
city: Irvine
country: United States
facility: UCI Gavin Herbert Eye Institute
state: California
city: Irvine
country: United States
facility: UCI Gottschalk Medical Plaza
state: California
city: La Jolla
country: United States
facility: Koman Family Outpatient Pavilion (Endoscopy)
state: California
city: La Jolla
country: United States
facility: Perlman Medical Offices (IBD Clinic)
state: California
city: La Jolla
country: United States
facility: UCSD Clinical and Translational Research Institute (Research Clinic)
state: California
city: La Jolla
country: United States
facility: UCSD Health System (PFT/Endoscopy)
state: California
city: La Jolla
country: United States
facility: UCSD lnvestigational Drug Service Pharmacy
state: California
city: La Jolla
country: United States
facility: Shiley Eye Institute (OCT)
state: California
city: La Mesa
country: United States
facility: Dr. Raed Al-Naser -Sharp Grossmont outpatient (DLCO procedure only)
state: California
city: La Mesa
country: United States
facility: Dr. Sally s. Lee in La Mesa (Ophthalmologist procedure only)
state: California
city: Lake Elsinore
country: United States
facility: Inland Pulmonary Specialists [PFT Only]
state: California
city: Lancaster
country: United States
facility: Advanced Endoscopy and Pain Center (Colonoscopy)
state: California
city: Lancaster
country: United States
facility: Advanced Imaging Center (Chest X-Ray)
state: California
city: Lancaster
country: United States
facility: Antelope Valley Eye Care (Ophthalmologist)
state: California
city: Lancaster
country: United States
facility: AV Pediatrics, Allergy and Family Medicine (PFT, Physical Exam, ECG Review, Lab Review)
state: California
city: Lancaster
country: United States
facility: Jatinder S. Pruthi, MD FACG CPI (Physical Exam, ECG Review, Lab Review)
state: California
city: Lancaster
country: United States
facility: OM Research LLC
state: California
city: Los Angeles
country: United States
facility: Abraham M. lshaaya MD (X-Ray)
state: California
city: Los Angeles
country: United States
facility: Entertainment Medical Group, Inc (Main Site, Subject Visits, IP Delivery/Storage, Regulatory,
state: California
city: Los Angeles
country: United States
facility: Advanced Vision Care (OCT)
state: California
city: Los Angeles
country: United States
facility: Century City Endoscopy (Colonoscopy - Nicholas Karyotakis M.D. Endoscopist)
state: California
city: Los Angeles
country: United States
facility: Gastrointestinal Biosciences Clinical Trials, LLC
state: California
city: Murrieta
country: United States
facility: United Surgery Center Murrieta [Endoscopy Only]
state: California
city: Murrieta
country: United States
facility: United Medical Doctors
state: California
city: Orange
country: United States
facility: CCR-ICTS Center for Innovative Patient Care
state: California
city: Orange
country: United States
facility: UCI Health Eye Care Services (Ophthalmoscopy and OCTs)
state: California
city: Orange
country: United States
facility: UCI Health H. H. Chao Comprehensive Digestive Disease Center
state: California
city: Orange
country: United States
facility: UCI Investigational Drug Services (IDSP - Pharmacy)
state: California
city: Orange
country: United States
facility: UCI Irvine Medical Center - Pulmonology Services - PFTs
state: California
city: San Diego
country: United States
facility: ACRC Studies
state: California
city: Temecula
country: United States
facility: California Eye Professionals [OCT Only]
state: California
city: Temecula
country: United States
facility: United Surgery Center Temecula [Endoscopy Only]
state: California
city: Colorado Springs
country: United States
facility: Front Range Endoscopy Center
state: Colorado
city: Colorado Springs
country: United States
facility: Peak Gastroenterology Associates
state: Colorado
city: Colorado Springs
country: United States
facility: Colorado Springs Pulmonary Consultants, PC
state: Colorado
city: Colorado Springs
country: United States
facility: The Wright Eye Center (OCT Facility)
state: Colorado
city: Colorado Springs
country: United States
facility: Colorado Springs Imaging
state: Colorado
city: Colorado Springs
country: United States
facility: Peak Gastroenterology Associates
state: Colorado
city: New Haven
country: United States
facility: Yale Ophtalmology
state: Connecticut
city: New Haven
country: United States
facility: Yale School of Medicine
state: Connecticut
city: New Haven
country: United States
facility: Yale New Haven Hospital - Winchester Chest Clinic - PFT
state: Connecticut
city: North Haven
country: United States
facility: Yale New Haven Hospital MEMC- Endoscopy
state: Connecticut
city: Brandon
country: United States
facility: Florida Advanced Gastroenterology Center - Rahman Nakshabendi MD and Imad Nakshabendi, MD
state: Florida
city: Clearwater
country: United States
facility: Bay Area Chest Physicians, P.A.,-(Pulmonary Function Test)
state: Florida
city: Clearwater
country: United States
facility: GASTRO FLORIDA (ADMINISTRATIVE DUTIES etc. CRA visits)
state: Florida
city: Clearwater
country: United States
facility: West Coast Endoscopy (Colonoscopy Procedures)
state: Florida
city: Clearwater
country: United States
facility: West Coast Endoscopy Center (Endoscopy Procedures)
state: Florida
city: Clearwater
country: United States
facility: West Coast Radiology (Chest X-ray)
state: Florida
city: Clearwater
country: United States
facility: Northwood Vision- Optical Coherence Tomography (OCT)
state: Florida
city: Coral Gables
country: United States
facility: Beraja Medical Institute (OCT)
state: Florida
city: Coral Gables
country: United States
facility: Juan Barrio, MD (PFT when needed)
state: Florida
city: Fort Myers
country: United States
facility: Retina Consultants of Southwest Florida, PA "OCT"
state: Florida
city: Miami
country: United States
facility: The Endoscopy Center (Endoscopy Procedure)
state: Florida
city: Miami
country: United States
facility: Research Associates of South Florida
state: Florida
city: Miami
country: United States
facility: Kendall Endoscopy and Surgery Center (Endoscopy)
state: Florida
city: Miami
country: United States
facility: Clarin Eye Care Center (OCT/Ophthalmoscopy)
state: Florida
city: Naples
country: United States
facility: Bruce Roy, MD "PFT"
state: Florida
city: Naples
country: United States
facility: Gastroenterology Group of Naples
state: Florida
city: Naples
country: United States
facility: Gulfshore Endoscopy Center
state: Florida
city: Naples
country: United States
facility: Radiology Regional Center "Chest x-ray"
state: Florida
city: New Smyrna Beach
country: United States
facility: NSB Research
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: South Miami
country: United States
facility: Larkin Community Hospital (Endoscopy Procedure)
state: Florida
city: Sun City Center
country: United States
facility: Absolute Surgical Specialists - Craig Amshel, MD
state: Florida
city: Tampa
country: United States
facility: SimonMed Imaging
state: Florida
city: Tampa
country: United States
facility: Perez Eye Center(OCT & Ophthalmoscopy only)
state: Florida
city: Tampa
country: United States
facility: Tampa Bay Endoscopy Center(Proctosigmoidoscopy & colonoscopy ONLY)
state: Florida
city: Tampa
country: United States
facility: Tampa Bay Endoscopy Center
state: Florida
city: Tampa
country: United States
facility: Lyracore Health Alliance, Tampa Bay Pulmonology (PFT only)
state: Florida
city: Tampa
country: United States
facility: Pulmonary and Sleep of Tampa Bay(PFT with DLCO only)
state: Florida
city: Tampa
country: United States
facility: GCP Clinical Research,LLC
state: Florida
city: Tampa
country: United States
facility: LoCicero Medical Group (PFT Procedure Only)
state: Florida
city: Tampa
country: United States
facility: NewsomEye (OCT only)
state: Florida
city: Tampa
country: United States
facility: South Tampa Surgery Center
state: Florida
city: Zephyrhills
country: United States
facility: Florida Medical Clinic, LLC (Endoscopy)
state: Florida
city: Zephyrhills
country: United States
facility: Florida Medical Clinic, LLC (OCT)
state: Florida
city: Zephyrhills
country: United States
facility: Florida Medical Clinic, LLC (PFT)
state: Florida
city: Zephyrhills
country: United States
facility: Florida Medical Clinic, LLC
state: Florida
city: Gurnee
country: United States
facility: GI Alliance (Patients Seen; IP Delivered)
state: Illinois
city: Gurnee
country: United States
facility: Medical Eye Services LTD (Ophthalmoscopy with OCT)
state: Illinois
city: Lake Bluff
country: United States
facility: North Shore Endoscopy Center (Endoscopy)
state: Illinois
city: Libertyville
country: United States
facility: Libertyville Imaging Center (Diagnostic Imaging)
state: Illinois
city: Chevy Chase
country: United States
facility: Chevy Chase Endoscopy Center (Endoscopy Facility Only)
state: Maryland
city: Chevy Chase
country: United States
facility: Chevy Chase Pulmonary Associate (PFT Only)
state: Maryland
city: Chevy Chase
country: United States
facility: Retina Group of Washington (Ophthalmoscopy and OCT Only)
state: Maryland
city: Columbia
country: United States
facility: Charter Radiology
state: Maryland
city: Columbia
country: United States
facility: Cascades Endoscopy Center
state: Maryland
city: Columbia
country: United States
facility: Gastro Center of Maryland, LLC
state: Maryland
city: Hanover
country: United States
facility: Kaylani Eye Care ( Optical Coherence Tomography and Opthalmoscopy only)
state: Maryland
city: Laurel
country: United States
facility: Lung Center (Pulmonary Function Test only)
state: Maryland
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Creve Coeur
country: United States
facility: Barnes-Jewish West County Hospital (Additional Endoscopy Location)
state: Missouri
city: Saint Louis
country: United States
facility: Center for Outpatient Health
state: Missouri
city: Saint Louis
country: United States
facility: Barnes-Jewish Hospital
state: Missouri
city: Saint Louis
country: United States
facility: Center for Advanced Medicine
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Beachwood
country: United States
facility: Advantage Diagnostics(X-Ray only)
state: Ohio
city: Chardon
country: United States
facility: Geauga Sleep Center(PFT only)
state: Ohio
city: Cincinnati
country: United States
facility: UC Health Physicians Office
state: Ohio
city: Cincinnati
country: United States
facility: UC Health (Pulmonary Function Testing)
state: Ohio
city: Cincinnati
country: United States
facility: University of Cincinnati College of Medicine
state: Ohio
city: Mentor
country: United States
facility: The Endoscopy Center of Lake County
state: Ohio
city: Painesville
country: United States
facility: Vitreo Retinal Consultants(OCT only)
state: Ohio
city: Willoughby Hills
country: United States
facility: Retina Specialists of Ohio(OCT only)
state: Ohio
city: Willoughby
country: United States
facility: Lake Pulmonary Associates (PFT only)
state: Ohio
city: Camp Hill
country: United States
facility: West Shore Endoscopy Center
state: Pennsylvania
city: Harrisburg
country: United States
facility: Pulmonary and Critical Care Medicine Associates (PFT only)
state: Pennsylvania
city: Harrisburg
country: United States
facility: Medical Arts Allergy,PC (PFT Only)
state: Pennsylvania
city: Harrisburg
country: United States
facility: Farrel Opthalmology(OCT only)
state: Pennsylvania
city: Harrisburg
country: United States
facility: Pinnacle Health Imaging at Tristan (X-Ray only)
state: Pennsylvania
city: Harrisburg
country: United States
facility: Susquehanna Research Group
state: Pennsylvania
city: Harrisburg
country: United States
facility: Harrisburg Eye Associates (OCT only)
state: Pennsylvania
city: Lemoyne
country: United States
facility: Pulmonary and Critical Care Medicine Associates (PFT only)
state: Pennsylvania
city: Edinburg
country: United States
facility: Advanced Radiology Associates (x-Ray only)
state: Texas
city: Grapevine
country: United States
facility: Texas Retina Associates (OCT Location)
state: Texas
city: Houston
country: United States
facility: Alkek Eye Center Jamail Specialtu Care Center (OCT)
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine- Baylor Medical Center
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine-Baylor Medical Center (Chest X-ray location)
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine-Baylor Medical Center (IP Storage)
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine-Baylor Medical Center (Patients seen address, ECG location, PFT)
state: Texas
city: Houston
country: United States
facility: Baylor St. Luke's Medical Center Endoscopy- Mc Nair Campus (Endoscopy Location)
state: Texas
city: Keller
country: United States
facility: Lonestar Endoscopy
state: Texas
city: McAllen
country: United States
facility: Buena Vista Optical ( OCT only)
state: Texas
city: McAllen
country: United States
facility: Endoscopy Center at Med Point (Endoscopy only)
state: Texas
city: McAllen
country: United States
facility: Valley Pulmonary Group (PFT only)
state: Texas
city: Southlake
country: United States
facility: Envision Imaging
state: Texas
city: Southlake
country: United States
facility: Lonestar Endoscopy
state: Texas
city: Southlake
country: United States
facility: Texas Digestive Disease Consultants, PLLC d/b/a GI Alliance
state: Texas
city: Tyler
country: United States
facility: Heaton Eye Associates (OCT only)
state: Texas
city: Tyler
country: United States
facility: Christus Trinity Mother Frances Endoscopy Center
state: Texas
city: Tyler
country: United States
facility: Christus Trinity Mother Frances Endosopy Center ( endoscopies only)
state: Texas
city: Tyler
country: United States
facility: Tyler Open MRI (chest x-ray only)
state: Texas
city: Tyler
country: United States
facility: UT Health East Texas Physicians (pulmonary functions only)
state: Texas
city: Victoria
country: United States
facility: Citizen Healthplex (PFT)
state: Texas
city: Victoria
country: United States
facility: Gastro Health & Nutrition - Victoria
state: Texas
city: Victoria
country: United States
facility: Surgery Center (Endoscopy)
state: Texas
city: Victoria
country: United States
facility: Victoria Eye Center (OCT and Opthalmoscopy)
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Huntsman Cancer Hospital Endoscopy
state: Utah
city: Salt Lake City
country: United States
facility: University of Utah Clinic and Endoscopy Suite - Sugarhouse
state: Utah
city: Salt Lake City
country: United States
facility: University of Utah Hospitals and Clinics (PFT)
state: Utah
city: Salt Lake City
country: United States
facility: University of Utah Moran Eye Center (Opthalmoscopy/OCT)
state: Utah
city: Forest
country: United States
facility: Harman Eye Center (OCT only)
state: Virginia
city: Lynchburg
country: United States
facility: Lynchburg Pulmonary Associates, Inc. (PFT only)
state: Virginia
city: Lynchburg
country: United States
facility: Blue Ridge Medical Research
state: Virginia
city: Lynchburg
country: United States
facility: Radiology Consultants of Lynchburg (X-ray only)
state: Virginia
city: Bellevue
country: United States
facility: Eastside Endoscopy Center
state: Washington
city: Bellevue
country: United States
facility: Overlake Clinics- Pulmonary Medicine
state: Washington
city: Bellevue
country: United States
facility: Washington Gastroenterology
state: Washington
city: Bellevue
country: United States
facility: Northwest Vision (OCT only)
state: Washington
city: Seattle
country: United States
facility: Pacific Northwest Retina
state: Washington
city: Seattle
country: United States
facility: Richard Bensinger, MD
state: Washington
city: Seattle
country: United States
facility: Swedish Gastroenterology
state: Washington
city: Seattle
country: United States
facility: Swedish Medical Center Investigational Drug Services Pharmacy
state: Washington
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Seattle
country: United States
facility: Swedish Medical Center First Hill Endoscopy Center
state: Washington
city: Seattle
country: United States
facility: Swedish Medical Center First Hill
state: Washington
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Milwaukee
country: United States
facility: Froedtert Memorial Lutheran Hospital
state: Wisconsin
city: Sydney
country: Australia
facility: Bankstown-Lidcombe Hospital
state: New South Wales
city: Birtinya
country: Australia
facility: Queensland Respiratory Services ,Pulse Oceanside Medical{PFT Facility )
state: Queensland
city: Birtinya
country: Australia
facility: Sunshine Coast Radiology
state: Queensland
city: Birtinya
country: Australia
facility: Sunshine Coast University Private Hospital
state: Queensland
city: Buderim
country: Australia
facility: Buderim Eye Centre( OCT and Ophthalmoscopy Facility)
state: Queensland
city: Mackay
country: Australia
facility: Coral Sea Clinical Research Institute Pty.Ltd
state: Queensland
city: Maroochydore
country: Australia
facility: Coastal Digestive Helath Pty. Ltd
state: Queensland
city: North Mackay
country: Australia
facility: Dr.Shiran DeSilva Respiratory Clinic (PFT)
state: Queensland
city: North Mackay
country: Australia
facility: Mater Misericordiae Hospital ( Endoscopy)
state: Queensland
city: North Mackay
country: Australia
facility: Queensland X-Ray
state: Queensland
city: North Mackay
country: Australia
facility: Vision Eye Institute Mackay (OCT)
state: Queensland
city: Heidelberg
country: Australia
facility: Austin Health
state: Victoria
city: Parkville
country: Australia
facility: Melbourne Health
state: Victoria
city: Gomel
country: Belarus
facility: Institution "Gomel Regional Specialized Clinical Hospital"
city: Gomel
country: Belarus
facility: Institution "Gomel Regional Clinical Hospital"
city: Grodno
country: Belarus
facility: Foreign Medical and Pharmaceutical Unitary Enterprise "Medical center "Novoe Zrenie"
city: Grodno
country: Belarus
facility: Health Care Institution "Grodno City Clinical Hospital #4"
city: Vitebsk
country: Belarus
facility: Vitebsk Regional Clinical Hospital
city: Vitebsk
country: Belarus
facility: Health Care Institution "Vitebsk Regional Clinical Specialized Center"
city: Vitebsk
country: Belarus
facility: Vitebsk Regional Clinical Specialized Center
city: Gent
country: Belgium
facility: AZ Sint-Lucas
city: Roeselare
country: Belgium
facility: AZ Delta
city: Ruse
country: Bulgaria
facility: UMHAT ,,Kanev" AD
city: Sliven
country: Bulgaria
facility: Diagnostic-Consultative Center I - Sliven, EOOD
city: Sofia
country: Bulgaria
facility: Acibadem City Clinic Multiprofile Hospital for Active Treatment Tokuda EAD
city: Sofia
country: Bulgaria
facility: Acibadem City Clinic University Hospital EOOD
city: Sofia
country: Bulgaria
facility: DCC Alexandrovska, EOOD
city: Sofia
country: Bulgaria
facility: UMHAT "Aleksandrovska" EAD (Colonoscopy/Sigmoidoscopy Facility)
city: Sofia
country: Bulgaria
facility: UMHAT Aleksandrovska EAD (Colonoscopy/OCT Facility)
city: Sofia
country: Bulgaria
facility: UMHAT Aleksandrovska EAD (X-Ray Facility)
city: Sofia
country: Bulgaria
facility: UMHAT "Tsaritsa Yoanna-ISUL" EAD
city: Sofia
country: Bulgaria
facility: UMHAT ''Tsaritsa Yoanna-lSUL" EAD (Colonoscopy/ Sigmoidoscopy Facility)
city: Sofia
country: Bulgaria
facility: UMHAT Tsaritsa Yoanna - ISUL EAD (X-ray)
city: Sofia
country: Bulgaria
facility: UMHAT ''Tsaritsa Yoanna-lSUL" EAD (Colonoscopy/ Sigmoidoscopy Facility)
city: Sofia
country: Bulgaria
facility: University multiprofile hospital for active treatment and emergency medicine N.l Pirogov EAD
city: Sofia
country: Bulgaria
facility: Diagnostic Consultation Center CONVEX EOOD
city: Sofia
country: Bulgaria
facility: Acibadem City Clinic University Hospital Eood
city: Veliko Tarnovo
country: Bulgaria
facility: Medical Centre MEDICA Plus OOD
city: Calgary
country: Canada
facility: University of Calgary, Department of Medicine - Respirology (PFT Only)
state: Alberta
city: Calgary
country: Canada
facility: University of Calgary, Heritage Medical Research Clinic
state: Alberta
city: Calgary
country: Canada
facility: University of Calgary, Department of Medicine - Opthalmology (OCT Only)
state: Alberta
city: London
country: Canada
facility: St. Joseph's Hospital (OCT Procedure only)
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre - University Hospital
state: Ontario
city: Montreal
country: Canada
facility: McGill University Health Center- Montreal General Hospital (Electrocardiogram Clinic)
state: Quebec
city: Montreal
country: Canada
facility: McGill University Health Center- Montreal General Hospital (Endoscopy clinic)
state: Quebec
city: Montreal
country: Canada
facility: McGill University Health Center- Montreal General Hospital (IP Address)
state: Quebec
city: Montreal
country: Canada
facility: McGill University Health Center- Montreal General Hospital (Research Site)
state: Quebec
city: Montreal
country: Canada
facility: Montreal General Hospital (MUHC-Radiology)
state: Quebec
city: Montreal
country: Canada
facility: Eye Health MD (OCT)
state: Quebec
city: Boskovice
country: Czechia
facility: Gastroenterologicka ambulance
city: Hradec Kralove
country: Czechia
facility: Hepato-Gastroenterologie HK, s.r.o.
city: Hradec Kralove
country: Czechia
facility: VISUS, spol s.r.o.
city: Olomouc
country: Czechia
facility: Gastroenterologicka ordinace MUDr. Pavla Skalova s.r.o., MUDr. Frantisek Sincl s.r.o.
city: Olomouc
country: Czechia
facility: Gastroenterologie-interna, SPEA
city: Olomouc
country: Czechia
facility: MUDr. Pavlina Kazinotova, s.r.o.
city: Olomouc
country: Czechia
facility: Ocni ordinace Olomouc
city: Olomouc
country: Czechia
facility: PreventaMed s.r.o.
city: Olomouc
country: Czechia
facility: Vojenska nemocnice Olomouc
city: Olomouc
country: Czechia
facility: Gastroenterologie-interna, SPEA
city: Olomouc
country: Czechia
facility: Vojenska nemocnice Olomouc
city: Ostrava-Poruba
country: Czechia
facility: Fakultni nemocnice Ostrava
city: Praha 7
country: Czechia
facility: Ocni centrum Praha, a.s.
city: Praha 9
country: Czechia
facility: ISCARE a.s.
city: Praha 9
country: Czechia
facility: Prvni plicni ambulance. s.r.o.
city: Prerov
country: Czechia
facility: Gastroenterologicka ambulance MUDr. Marcela Vyslouzilova
city: Prostejov
country: Czechia
facility: Privatni gastroenterologicka ambulance s.r.o. MUDr. Zdenek Vlk
city: Slany
country: Czechia
facility: Nemocnice Slany
city: Slany
country: Czechia
facility: Poliklinika Slany, spol. s.r.o.
city: Vsetin
country: Czechia
facility: Gatronell s.r.o
city: Clermont-Ferrand Cedex 1
country: France
facility: Centre Hospitalier Universitaire de Clermont-Ferrand - Hopital Estaing
city: Grenoble
country: France
facility: Centre Hospitalier Universitaire de Genoble Alpes - CHU Michallon
city: Nantes Cedex 1
country: France
facility: Centre Hospitalier Universitaire de Nantes - Hotel-Dieu
city: Nice Cedex 3
country: France
facility: Centre Hospitalier Universitaire de Nice - Hopital de l'Archet 2
city: Rennes Cedex 09
country: France
facility: CHU RENNES - Hopital Pontchaillou
city: Tbilisi
country: Georgia
facility: LLC Academic Pridon Todua Medical Center - LLC Research Institute of Clinical Medicine
city: Tbilisi
country: Georgia
facility: LLC Todua Clinic
city: Tbilisi
country: Georgia
facility: LTD Israeli-Georgian Medical Research Clinic Helsicore
city: Tbilisi
country: Georgia
facility: LTD Vivamedi
city: Tbilisi
country: Georgia
facility: LTD Institute of Clinical Cardiology
city: Tbilisi
country: Georgia
facility: Medical Center CITO LTD
city: Tbilisi
country: Georgia
facility: JSC Infectious Diseases, AIDS and Clinical Immunology Research Center
city: Tbilisi
country: Georgia
facility: LTD Academician Nikoloz Kipshidze Central University Clinic
city: Tbilisi
country: Georgia
facility: LTD Aversi Clinic
city: Tbilisi
country: Georgia
facility: LTD Malkhaz Katsiashvili Multiprofile Emergency Medicine Center
city: Berlin
country: Germany
facility: Charite - Universitatsmedizin Berlin, Campus Mitte (CCM)
city: Berlin
country: Germany
facility: OCT Charite - Universitatsmedizin Berlin
city: Berlin
country: Germany
facility: PFT Klinik fur Infektiologie & Pneumologie
city: Bonn
country: Germany
facility: Praxiskooperation Bonn-Euskirchen-Rheinbach-Wesseling
city: Duesseldorf
country: Germany
facility: Florence-Nightingale-Krankenhaus
city: Kiel
country: Germany
facility: OCT: nordBLICK Augenklinik Bellevue
city: Kiel
country: Germany
facility: Universitatsklinikum Schleswig-Holstein, Campus Kiel
city: Krefeld
country: Germany
facility: OCT: Dr. med. Christopher Kallen
city: Neuss
country: Germany
facility: Johanna Etienne Krankenhaus
city: Neuss
country: Germany
facility: OCT: AOZ Neuss
city: Remscheid
country: Germany
facility: OCT: Augenpraxisklinik REMSCHEID
city: Remscheid
country: Germany
facility: Magen-Darm-Zentrum Remscheid
city: Gyongyos
country: Hungary
facility: Bugat Pal Korhaz
state: Heves
city: Tatabanya
country: Hungary
facility: DLCO and ophthalmology tests: Szent Borbala Korhaz
state: Komarom-esztergom
city: Szekszard
country: Hungary
facility: Clinfan Szolgaltato Kft.
state: Tolna
city: Szekszard
country: Hungary
facility: Ophthalmology tests: Tolna Megyei Balassa Janos Korhaz
state: Tolna
city: Budapest
country: Hungary
facility: Ophthalmology tests: Tosho Kft.
city: Budapest
country: Hungary
facility: Mediszem Kft.
city: Budapest
country: Hungary
facility: Endoexpert EgeszsegUgyi Szolgaltato Kft.
city: Budapest
country: Hungary
facility: Magyar Honvedseg Egeszsegugyi Kozpont (Ophthalmology Tests)
city: Budapest
country: Hungary
facility: Pulmonary function test: Vasutegeszsegugyi Nonprofit Kozhasznu Kft.
city: Budapest
country: Hungary
facility: Vasutegeszsegugyi Nonprofit Kozhasznu Kft. (Pulmonary function)
city: Budapest
country: Hungary
facility: Vasutegeszsegugyi Nonprofit Kozhasznu Kft.
city: Budapest
country: Hungary
facility: Honvedkorhaz II. telephely
city: Budapest
country: Hungary
facility: Magyar Honvedseg Egeszsegugyi Kozpont (Ophthalmology Tests)
city: Budapest
country: Hungary
facility: Semmelweis Egyetem Belgyógyászati és Hematológiai Klinika
city: Budapest
country: Hungary
facility: Pannonia Maganorvosi Centrum Kft.
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont, Belgyogyaszati Klinika, Gasztroenterologia
city: Szeged
country: Hungary
facility: Opthalmology tests: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont,Szemeszeti Klinika
city: Szeged
country: Hungary
facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont, Belgyogyaszati Klinika
city: Holon
country: Israel
facility: Edith Wolfson Medical Center
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Nahariya
country: Israel
facility: Galilee Medical Center
city: Petah Tikva
country: Israel
facility: Rabin Medical Center
city: Rehovot
country: Israel
facility: Kaplan Medical Center
city: Puglia
country: Italy
facility: Azienda Ospedaliera Saverio De Bellis
state: Bari
city: Garbagnate Milanese
country: Italy
facility: ASST Rhodense - Pneumology Unit
state: Milan
city: Milano
country: Italy
facility: IRCCS Ospedale San Raffaele, Unita di Gastroenterologia
state: Milan
city: Rho
country: Italy
facility: ASST Rhodense - Ophthalmology Unit (For Ophthalmoscopy)
state: Milan
city: Rho
country: Italy
facility: ASST Rhodense - Ophthalmology Unit
state: Milan
city: Rho
country: Italy
facility: ASST Rhodense - U.O.C. di Gastroenterologia ed Endoscopia Digestiva
state: Milan
city: Roma
country: Italy
facility: Fondazione Policlinico Agostino Gemelli IRCCS
state: Rome
city: Vicenza
country: Italy
facility: Ospedale San Bortolo di Vicenza, Gastroenterologia
state: Veneto
city: Wonju-si
country: Korea, Republic of
facility: Yonsei University Wonju Severance Christian Hospital
state: Gangwon-do
city: Wonju
country: Korea, Republic of
facility: Wonju Severance Christian Hospital
state: Gangwon-do
city: Wonju
country: Korea, Republic of
facility: Wonju Severance Christian Hospital
state: Kang-won-do
city: Daegu
country: Korea, Republic of
facility: Endoscopy Facility in Kyungpook National University Chilgok Hospital
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Chilgok Hospital
city: Daegu
country: Korea, Republic of
facility: OCT Facility in Kyungpook National University Chilgok Hospital
city: Daegu
country: Korea, Republic of
facility: PFT Facility in Kyungpook National University Chilgok Hospital
city: Daegu
country: Korea, Republic of
facility: Endoscopy Facility in kyungpook National University Hospital
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
city: Daegu
country: Korea, Republic of
facility: OCT Facility In kyungpook Natioanl University Hospital
city: Daegu
country: Korea, Republic of
facility: PFT Facility in kyungpook Natioanl University Hospital
city: Seoul
country: Korea, Republic of
facility: Endoscopy Facility in Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: OCT(1) Facility in Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: OCT(2) Facility in Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: PFT(1) Facility Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: PFT(2) Facility Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Wroclaw
country: Poland
facility: Centrum Medyczne Oporow
state: Dolnoslaskie
city: Wroclaw
country: Poland
facility: OKOLEK
state: Dolnoslaskie
city: Wroclaw
country: Poland
facility: EuroMediCare Szpital Specjalistyczny z Przychodnia we Wroclawiu
state: Dolnoslaskie
city: Lodz
country: Poland
facility: Amicare Sp. z o.o. Sp.k.
state: Lodzkie
city: Lodz
country: Poland
facility: IP Clinic Sp. z o.o.
state: Lodzkie
city: Lodz
country: Poland
facility: Amicare Sp. z o.o. Sp.k.
state: Lodzkie
city: Nowy Targ
country: Poland
facility: Allmedica Badania Kliniczne Sp. z o.o. Sp. k.
state: Malopolskie
city: Oswiecim
country: Poland
facility: Medicome Sp. z o.o.
state: Malopolskie
city: Warszawa
country: Poland
facility: Centrum Zdrowia MDM
state: Mazowieckie
city: Warszawa
country: Poland
facility: lnstytut Gruzlicy i Chorob Pluc
state: Mazowieckie
city: Poznan
country: Poland
facility: Centrum Medyczne Grunwald
state: Wielkopolskie
city: Poznan
country: Poland
facility: Specjalistyczny Okulistyczny Niepubliczny Zaklad Opieki Zdrowotnej OCUSERVICE
state: Wielkopolskie
city: Poznan
country: Poland
facility: NSZOZ Termedica - Centrum Badan Klinicznych
state: Wielkopolskie
city: Poznan
country: Poland
facility: NSZOZ Termedica
state: Wielkopolskie
city: Poznan
country: Poland
facility: Szpital Sw. Wojciecha
state: Wielkopolskie
city: Szczecin
country: Poland
facility: Spoldzielnia Pracy Lekarzy Specjalistow Medicus (for OCT)
state: Zachodniopomorskie
city: Szczecin
country: Poland
facility: Twoja Przychodnia-Szczecinskie Centrum Medyczne
state: Zachodniopomorskie
city: Szczecin
country: Poland
facility: Przychodnia EVOMED Pracownia USG i RTG
state: Zachodniopomorskie
city: Bystra
country: Poland
facility: Centrum Pulmonologii i Torakochirurgii w Bystrej (DLCO)
city: Lodz
country: Poland
facility: Centrum Medyczne Ksiezy Mlyn sp. z o.o. (Ophtalmoscopy, OCT)
city: Lodz
country: Poland
facility: Centra Medyczne 'MEDYCEUSZ" (Chest X-Ray)
city: Lodz
country: Poland
facility: Wojewodzki Szpital Specjalistyczny im.dr. WI. Bieganskiego (endoscopy)
city: Lodz
country: Poland
facility: Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
city: Oswiecim
country: Poland
facility: MEDICOME- Oswiecimskie Centrum Medyczne (OCT)
city: Poznan
country: Poland
facility: Centrum Medyczne Grunwald
city: Poznan
country: Poland
facility: Centrum Medyczne Grunwald
city: Warsaw
country: Poland
facility: Centrum Zdrowia MDM
city: Warszawa
country: Poland
facility: Centrum Zdrowia MDM
city: Warszawa
country: Poland
facility: Centrum Zdrowia MDM
city: Wroclaw
country: Poland
facility: Endomed
city: Porto
country: Portugal
facility: Centro Hospitalar Universitario de Sao Joao, E.P.E
city: Pyatigorsk
country: Russian Federation
facility: "Clinic Ultrasound 4D" LLC
state: Stavropol Region
city: Pyatigorsk
country: Russian Federation
facility: "Platnaya poliklinika" LLC
state: Stavropol Region
city: Nizhniy Novgorod
country: Russian Federation
facility: SBHI of Nizhniy Novgorod region "Nizhniy Novgorod Regional Clinical Hospital n.a. N.A. Semashko
city: Omsk
country: Russian Federation
facility: BHI of Omsk region "Clinical oncology dispensary"
city: Omsk
country: Russian Federation
facility: Clinicodiagnostic center "Ultramed"
city: Omsk
country: Russian Federation
facility: Medical center "Intervzglyad"
city: Saint Petersburg
country: Russian Federation
facility: FSBEI of Higher Education "I.P.Pavlov First Saint Petersburg State Medical University" of MoH of RF
city: Samara
country: Russian Federation
facility: Private Institution, Educational Organization of Higher Education "Medical University "Reaviz"
city: Samara
country: Russian Federation
facility: Private Institution, Educational Organization of Higher Education "Medical University "Reaviz",
city: Samara
country: Russian Federation
facility: Clinical Hospital Russian Railways - Medicina
city: Samara
country: Russian Federation
facility: Medical Company "Hepatolog" LLC
city: Samara
country: Russian Federation
facility: Medical Company "Hepatolog" LLC
city: Samara
country: Russian Federation
facility: Samara Diagnostic center
city: Samara
country: Russian Federation
facility: Regional Medical center LLC (Branchevsky's clinic)
city: Smolensk
country: Russian Federation
facility: Inter-branch scientific and technical complex "Eye microsurgery"
city: Smolensk
country: Russian Federation
facility: Multidisciplinary Medical center "Clinic Park"
city: Smolensk
country: Russian Federation
facility: "Uromed" LLC
city: St. Petersburg
country: Russian Federation
facility: FSBEI of Higher Education "North-Western State Medical University n.a. I.I. Mechnikov" of MoH RF
city: Stavropol
country: Russian Federation
facility: Autonomous Noncommercial Medical Organization "Stavropol Regional Clinical Advisory-Diagnostic
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante
city: Madrid
country: Spain
facility: Hospital Universitario la Paz
city: Dnipro
country: Ukraine
facility: Limited Liability Company "Lookout "Medical Center"
city: Dnipro
country: Ukraine
facility: Limited Liability Company "MDC EXPERT"
city: Dnipro
country: Ukraine
facility: Municipal Enterprise <<Dnipro Reg Clinical Hosp named after M. I.I. Mechnikov>>
city: Ivano-Frankivsk
country: Ukraine
facility: Clinical Diagnostical Center "Simedgroup"
city: Ivano-Frankivsk
country: Ukraine
facility: CNE Regional Clinical Hospital of Ivano-Frankivsk Regional Council,Department of Gastroenterology
city: Kharkiv
country: Ukraine
facility: Llc "Ldts-Skaymed"
city: Kharkiv
country: Ukraine
facility: CNE Prof. O.O. Shalimov City Clinical Hospital #2 of Kharkiv City Council, Department of Proctology
city: Kharkiv
country: Ukraine
facility: Llc Medical Center Oftalmika
city: Kyiv
country: Ukraine
facility: CNE Kyiv City Clinical Hospital #1 of Executive Body of Kyiv City Council (Kyiv City State
city: Uzhgorod
country: Ukraine
facility: Transcarpathian Center of Eye Microsurgery
city: Uzhgorod
country: Ukraine
facility: CNE Andrii Novak Transcarpathian Regional Clinical Hospital of
city: Vinnytsia
country: Ukraine
facility: Medical Center of LLC Health Clinic, Med Clinical lnvestigational Center, Unit of Gastroenterology,
city: Vinnytsia
country: Ukraine
facility: CNE "Vinnytsia Reg Clinical Hosp named after N.I.Pirogov Vinnytsia Regional Council", Reg Specialize
city: Vinnytsia
country: Ukraine
facility: Podilskyi tsentr zoru
city: Vinnytsia
country: Ukraine
facility: Scientific and Research Institute of lnvalid Rehabilitation (Educational and Scientific
city: Vinnytsya
country: Ukraine
facility: Diagnostic Center "Mediscan"
city: Vinnytsya
country: Ukraine
facility: Llc "Optimal M"
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: