Clinical trial NCT01470612: Long-Term Study Of CP-690,550 In Subjects With Ulcerative Colitis
Official title: A MULTI-CENTER, OPEN-LABEL STUDY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ulcerative Colitis
Keywords: Ulcerative colitis
open-label
long term treatment
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-11-11
Enrollment: 944
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is an open label, long-term extension study for subjects with moderate to severe ulcerative colitis designed to evaluate long term therapy of CP-690,550.


Eligibility criteria: Inclusion Criteria:

* Subjects who completed induction studies A3921094 or A3921095 and were classified as not meeting clinical response criteria; OR
* Subjects who completed maintenance study A3921096 or who discontinued treatment early in Study A3921096 due to treatment failure.

Exclusion Criteria:

* Subjects who had a major protocol violation in Study A3921094, A3921095 or A3921096.
* Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, or clinical findings suggestive of Crohn's disease.
* Subjects who have had surgery for ulcerative colitis or in the opinion of the investigator, are likely to require surgery for ulcerative colitis during the study period.

Primary outcomes:
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group)
measure: Number of Participants With Serious Infections as Treatment Emergent Adverse Events (TEAEs)
timeFrame: Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group)
measure: Number of Participants With Laboratory Test Abnormalities
timeFrame: Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group)
measure: Number of Participants With Vital Sign Abnormalities
timeFrame: Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group)
measure: Number of Participants With Clinically Significant Changes in Physical Examinations From Baseline
timeFrame: Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group)
measure: Number of Participants With Electrocardiogram (ECG) Abnormalities
timeFrame: Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group)
measure: Incidence Rates for Adjudicated Cardiovascular, Malignancy, Opportunistic Infections and Thromboembolic Safety Events
timeFrame: Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group)
Secondary outcomes:
measure: Number of Participants in Remission at Months 2, 12, 24 and 36: Observed Cases
timeFrame: Months 2, 12, 24 and 36
measure: Number of Participants in Remission at Months 2, 12, 24 and 36: Non-responder Imputation- Last Observation Carried Forward (NRI-LOCF)
timeFrame: Months 2, 12, 24 and 36
measure: Number of Participants in Clinical Remission at Months 2, 12, 24 and 36: Observed Cases
timeFrame: Months 2, 12, 24 and 36
measure: Number of Participants in Clinical Remission at Months 2, 12, 24 and 36: Non-responder Imputation- Last Observation Carried Forward (NRI-LOCF)
timeFrame: Months 2, 12, 24 and 36
measure: Number of Participants in Partial Mayo Score (PMS) Remission at Months 1, 4, 6, 9, 15, 18, 21, 27, 30, 33, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84: Observed Cases
timeFrame: Months 1, 4, 6, 9, 15, 18, 21, 27, 30, 33, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84
measure: Number of Participants in Partial Mayo Score (PMS) Remission at Months 1, 4, 6, 9, 15, 18, 21, 27, 30, 33, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84: Non-responder Imputation- Last Observation Carried Forward (NRI-LOCF)
timeFrame: Months 1, 4, 6, 9, 15, 18, 21, 27, 30, 33, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84
measure: Number of Participants Who Achieved Mucosal Healing at Months 2, 12, 24 and 36: Observed Cases
timeFrame: Months 2, 12, 24 and 36
measure: Number of Participants Who Achieved Mucosal Healing at Months 2, 12, 24 and 36: Non-responder Imputation- Last Observation Carried Forward (NRI-LOCF)
timeFrame: Months 2, 12, 24 and 36
measure: Number of Participants With Total Inflammatory Bowel Disease Questionnaire (IBDQ) Score >=170 at Months 2, 6, 12, 18, 24, 30, 36, 48, 60, 72 and 84: Non-responder Imputation- Last Observation Carried Forward (NRI-LOCF)
timeFrame: Months 2, 6, 12, 18, 24, 30, 36, 48, 60, 72 and 84
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Alabama Medical Group, P.C.
state: Alabama
city: Tucson
country: United States
facility: Desert Sun Clinical Research, LLC
state: Arizona
city: Tucson
country: United States
facility: Desert Sun Gastroenterology
state: Arizona
city: Tucson
country: United States
facility: Desert Sun Surgery Center
state: Arizona
city: La Jolla
country: United States
facility: Altman Clinical and Translational Research Institute
state: California
city: La Jolla
country: United States
facility: Perlman Medical Offices - UC San Diego Health System
state: California
city: La Jolla
country: United States
facility: UCSD Medical Center
state: California
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
city: Los Angeles
country: United States
facility: Cedars Sinai Surgery Center
state: California
city: Oceanside
country: United States
facility: Alliance Clinical Research
state: California
city: Oceanside
country: United States
facility: Center for Endoscopy- Covenant Surgical Partners
state: California
city: San Diego
country: United States
facility: Sharp Rees-Stealy Medical Group, Inc.
state: California
city: San Diego
country: United States
facility: Clinical Applications Laboratories, Inc
state: California
city: San Diego
country: United States
facility: Sharp Rees-Stealy Medical Group
state: California
city: San Francisco
country: United States
facility: UCSF Center for Colitis and Crohn's Disease
state: California
city: Bristol
country: United States
facility: Connecticut Clinical Research Institute
state: Connecticut
city: Guilford
country: United States
facility: Endoscopy Center of Connecticut, LLC
state: Connecticut
city: Hamden
country: United States
facility: Endoscopy Center of Connecticut, LLC
state: Connecticut
city: Hamden
country: United States
facility: Gastroenterology Center of Connecticut, PC
state: Connecticut
city: Hamden
country: United States
facility: Medical Research Center of Connecticut, LLC
state: Connecticut
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Inverness
country: United States
facility: Nature Coast Clinical Research
state: Florida
city: Orange Park
country: United States
facility: North Florida Gastroenterology Research, LLC
state: Florida
city: Orlando
country: United States
facility: Citrus Ambulatory Surgery Center
state: Florida
city: Orlando
country: United States
facility: Internal Medicine Specialists
state: Florida
city: Port Orange
country: United States
facility: Advanced Gastroenterology Center
state: Florida
city: Port Orange
country: United States
facility: Advanced Medical Research Center
state: Florida
city: Port Orange
country: United States
facility: Endoscopy Center
state: Florida
city: Port Orange
country: United States
facility: Port Orange Urgent Care
state: Florida
city: Zephyrhills
country: United States
facility: Florida Medical Clinic, P.A.
state: Florida
city: Decatur
country: United States
facility: Atlanta Center for Gastroenterology, P.C.
state: Georgia
city: Macon
country: United States
facility: Gastroenterology Associates of Central Georgia, LLC
state: Georgia
city: Suwanee
country: United States
facility: Atlanta Gastroenterology Specialists, PC
state: Georgia
city: Topeka
country: United States
facility: Cotton O'Neil Clinical Research Center, Digestive Health
state: Kansas
city: Catonsville
country: United States
facility: Digestive Disease Associates, PA
state: Maryland
city: Catonsville
country: United States
facility: Gastrointestinal Diagnostic Center
state: Maryland
city: Chevy Chase
country: United States
facility: MGG Group Co., Inc., Chevy Chase Clinical Research
state: Maryland
city: Columbia
country: United States
facility: Howard County GIDC
state: Maryland
city: Ann Arbor
country: United States
facility: East Ann Arbor Health and Geriatrics Center -UMHS
state: Michigan
city: Ann Arbor
country: United States
facility: Michigan Clinical Research Unit - UMHS
state: Michigan
city: Ann Arbor
country: United States
facility: Medical Science Research Building 1 - UMHS
state: Michigan
city: Ann Arbor
country: United States
facility: University of Michigan Health Systems
state: Michigan
city: Chesterfield
country: United States
facility: Clinical Research Institute of Michigan, LLC
state: Michigan
city: Troy
country: United States
facility: Center for Digestive Health
state: Michigan
city: Troy
country: United States
facility: Surgical Centers of Michigan
state: Michigan
city: Ypsilanti
country: United States
facility: Huron Gastroenterology Associates - Center for Digestive Care
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
city: Egg Harbor Township
country: United States
facility: AGA Clinical Research Associates, LLC
state: New Jersey
city: Marlton
country: United States
facility: South Jersey Gastroenterology, P.A.
state: New Jersey
city: Vineland
country: United States
facility: The Gastroenterology Group of South Jersey
state: New Jersey
city: Lake Success
country: United States
facility: NYU Langone Long Island Clinical Research Associates
state: New York
city: New York
country: United States
facility: IBD Center - The Mount Sinai Hospital
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
city: New York
country: United States
facility: Kornbluth, Legnani, George MD, PC
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Greenville
country: United States
facility: Carolina Research, Carolina Digestive Diseases
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Mentor
country: United States
facility: Great Lakes Gastroenterology Research, LLC
state: Ohio
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Arlington
country: United States
facility: Texas Clinical Research Institute
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine- Baylor Medical Center
state: Texas
city: Houston
country: United States
facility: McGovern Medical School -The University of Texas Health Science Center at Houston
state: Texas
city: Houston
country: United States
facility: Memorial Hermann Hospital
state: Texas
city: Tyler
country: United States
facility: Tyler Research Institute, LLC
state: Texas
city: Salt Lake City
country: United States
facility: Alpine Medical Group
state: Utah
city: Salt Lake City
country: United States
facility: Salt Lake Regional Hospital
state: Utah
city: Salt Lake City
country: United States
facility: Wasatch Clinical Research
state: Utah
city: Richmond
country: United States
facility: VCU Health System Digestive Health Center
state: Virginia
city: Richmond
country: United States
facility: VCU Health System Endoscopy Suite
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Milwaukee
country: United States
facility: Center for Digestive Health
state: Wisconsin
city: Milwaukee
country: United States
facility: Wisconsin Center for Advanced Research - a division of GI Associates, LLC
state: Wisconsin
city: Garran
country: Australia
facility: The Canberra Hospital
state: Australian Capital Territory
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: Concord
country: Australia
facility: Concord Repatriation General Hospital
state: New South Wales
city: Kingswood
country: Australia
facility: Nepean Hospital
state: New South Wales
city: Liverpool
country: Australia
facility: Liverpool Hospital eastern Campus
state: New South Wales
city: Box Hill
country: Australia
facility: Eastern Health, Box Hill Hospital
state: Victoria
city: Clayton
country: Australia
facility: Gastroenterology and Hepatology Unit
state: Victoria
city: Innsbruck
country: Austria
facility: Landeskrankenhaus Innsbruck
city: St. Veit an der Glan
country: Austria
facility: Krankenhaus Barmherzige Brueder St. Veit/Glan
city: Wien
country: Austria
facility: AKH Wien, Universitaetsklinik fuer Innere Medizin III
city: Antwerpen
country: Belgium
facility: GZA St Vincentius
city: Kortrijk
country: Belgium
facility: AZ Groeninge
city: Leuven
country: Belgium
facility: UZ Leuven (University Hospital Leuven), Campus Gasthuisberg
city: Roeselare
country: Belgium
facility: H-Hartziekenhuis Roeselare-Menen vzw
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre - HCPA
state: RIO Grande DO SUL
city: Calgary
country: Canada
facility: University of Calgary, Heritage Medical Research Clinic, TRW Building
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta Hospital - Walter C. Mackenzie Health Sciences Centre
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta - Zeidler Ledcor Centre
state: Alberta
city: Hamilton
country: Canada
facility: McMaster University Medical Center
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre - University Hospital
state: Ontario
city: Montreal
country: Canada
facility: Hopital Maisonneuve-Rosemont/Pavillon Rachel-Tourigny
state: Quebec
city: Montreal
country: Canada
facility: Montreal General Hospital - McGill University Health Care Centre
state: Quebec
city: Saskatoon
country: Canada
facility: Saskatoon City Hospital
state: Saskatchewan
city: Saskatoon
country: Canada
facility: Royal University Hospital
state: Saskatchewan
city: Medellin
country: Colombia
facility: Instituto de Coloproctologia ICO S.A.S.
state: Antioquia
city: Zagreb
country: Croatia
facility: University Hospital Center Zagreb
city: Hradec Kralove
country: Czechia
facility: Hepato-Gastroenterologie HK, s.r.o.
city: Praha 7
country: Czechia
facility: Klinicke Centrum ISCARE I.V.F., Gastroenterologie
city: Strakonice
country: Czechia
facility: Nemocnice Strakonice, a.s., Interni oddeleni
city: Usti Nad Labem
country: Czechia
facility: Krajska Zdravotni, A.S.,
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital
state: NV
city: Aalborg
country: Denmark
facility: Aalborg Hospital
city: Aarhus C
country: Denmark
facility: Aarhus University Hospital
city: Hvidovre
country: Denmark
facility: Hvidovre Hospital
city: Odense C
country: Denmark
facility: Odense University Hospital
city: Tallinn
country: Estonia
facility: West Tallinn Central Hospital
state: Harjumaa
city: Tallinn
country: Estonia
facility: Innomedica OU
city: Amiens Cedex 01
country: France
facility: CHU Amiens-Picardie - Hopital Sud
city: Clichy
country: France
facility: Hopital Beaujon, Gastroenterologie, MICI et Assistance Nutritive
city: Nantes
country: France
facility: CHU de Nantes - Hotel Dieu-Service d'Hepato-Gastroenterologie
city: Paris cedex 12
country: France
facility: Hopital Saint Antoine - Service de Gastroenterologie
city: Paris
country: France
facility: Hôpital Saint Louis - Service d'hepato-gastroenterologie
city: Paris
country: France
facility: Hôpital Saint Louis
city: Pessac
country: France
facility: Hopital Haut-Leveque-CMC Magellan- Unite de Recherche Clinique
city: Reims cedex
country: France
facility: CHU de Reims - Hopital Robert Debre
city: St Priest En Jarez
country: France
facility: Hopital Nord
city: Toulouse Cedex 9
country: France
facility: Hopital Rangueil
city: Kiel
country: Germany
facility: Universitatsklinikum Schleswig-Holstein, Campus Kiel
state: Schlewig Holstein
city: Berlin
country: Germany
facility: Universitaetsmedizin Berlin, Charite Campus Virchow-Klinikum, Medizinische Klinik mit
city: Halle
country: Germany
facility: Universitaesklinikum Halle, Klinik und Poliklinik fuer Innere Medizin I
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Lüneburg
country: Germany
facility: Klinikum Lüneburg
city: Minden
country: Germany
facility: Gastroenterologische Gemeinschaftspraxis Minden
city: Munich
country: Germany
facility: University Hospital Munich-Grosshadern
city: Ulm
country: Germany
facility: Universitaetsklinikum Ulm
city: Bekescsaba
country: Hungary
facility: Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaza; III. Belgyogyaszat - Gasztroenterologia'.
city: Budapest
country: Hungary
facility: Peterfy Sandor utcai Korhaz-Rendelointezet es Manninger Jeno Orszagos Traumatologiai Intezet
city: Budapest
country: Hungary
facility: Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak I Belgyogyaszati-Gasztroenterologiai Osztaly
city: Budapest
country: Hungary
facility: Pannonia Maganorvosi Centrum Kft.
city: Budapest
country: Hungary
facility: Szent Margit Kórház, III. Belgyógyászati-Gasztroenterológiai Osztály
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont
city: Gyula
country: Hungary
facility: Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza III.sz. Belgyoyaszat Gasztroenterologia
city: Miskolc
country: Hungary
facility: Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz
city: Mosonmagyarovar
country: Hungary
facility: Karolina Korhaz
city: Pecs
country: Hungary
facility: Pecsi Tudomanyegyetem Klinikai Kozpont
city: Szeged
country: Hungary
facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont, I. Sz. Belgyogyaszati Klinika
city: Vac
country: Hungary
facility: Javorszky Odon Korhaz
city: Haifa
country: Israel
facility: Rambam Health Care Campus
city: Holon
country: Israel
facility: The Edith Wolfson Medical Center/Gastroenterology Department
city: Petah Tikva
country: Israel
facility: Rabin Medical Center, Beilinson campus
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas IRCCS-IBD Center
state: Milano
city: Palermo
country: Italy
facility: AOR Villa Sofia-Cervello
state: PA
city: Catanzaro
country: Italy
facility: AOU Mater Domini - U.O. Fisiopatologia Digestiva
city: Nagakute
country: Japan
facility: Aichi Medical University Hospital
state: Aichi
city: Hirosaki
country: Japan
facility: National Hospital Organization Hirosaki National Hospital
state: Aomori
city: Sakura
country: Japan
facility: Toho University Sakura Medical Center
state: Chiba
city: Kurume
country: Japan
facility: Kurume University Hospital
state: Fukuoka
city: Sapporo
country: Japan
facility: Hokkaido P.W.F.A.C Sapporo-Kosei general Hospital
state: Hokkaido
city: Higashi-ibaraki-gun
country: Japan
facility: National Hospital Organization Mito Medical Center
state: Ibaraki
city: Kagoshima-shi
country: Japan
facility: Sameshima Hospital
state: Kagoshima
city: Kochi-shi
country: Japan
facility: Kuniyoshi Hospital
state: Kochi
city: Sendai
country: Japan
facility: National Hospital Organization Sendai Medical Center
state: Miyagi
city: Osaka-City
country: Japan
facility: Osaka City University Hospital
state: Osaka
city: Takatsuki-shi
country: Japan
facility: Osaka Medical College Hospital
state: Osaka
city: Otsu
country: Japan
facility: Shiga University of Medical Science Hospital
state: Shiga
city: Bunkyo-ku
country: Japan
facility: Tokyo Medical And Dental University Hospital, Faculty of Medicine
state: Tokyo
city: Hachioji
country: Japan
facility: Tokai University Hachioji 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: Shinjuku-ku
country: Japan
facility: Keio University Hospital
state: Tokyo
city: Fukuoka
country: Japan
facility: Fukuoka University Chikushi Hospital
city: Hiroshima
country: Japan
facility: Hiroshima University Hospital
city: Hyogo
country: Japan
facility: The Hospital of Hyogo College of Medicine
city: Tokyo
country: Japan
facility: Showa University Hospital
city: Guri-si
country: Korea, Republic of
facility: Hanyang University Guri Hospital
state: Gyeonggi-do
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital,
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Riga
country: Latvia
facility: Digestive Diseases Center GASTRO
city: Amsterdam
country: Netherlands
facility: VU University Medical Center
city: Amsterdam
country: Netherlands
facility: Academic Medical Center (AMC)
city: Groningen
country: Netherlands
facility: University Medical Center Groningen (UMCG)
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
city: Tauranga
country: New Zealand
facility: Clinical Trials Unit- Tauranga Hospital-Bay of Plenty (BOP) Clinical School
state: BAY OF Plenty
city: Christchurch
country: New Zealand
facility: Christchurch Hospital
state: Canterbury
city: Auckland
country: New Zealand
facility: North Shore Hospital (Waitemata District Health Board)
city: Auckland
country: New Zealand
facility: Auckland City Hospital
city: Dunedin
country: New Zealand
facility: Southern District Health Board
city: Hamilton
country: New Zealand
facility: Waikato Hospital
city: Wellington
country: New Zealand
facility: P3 Research Limited
city: Lodz
country: Poland
facility: Centrum Medyczne Szpital Sw. Rodziny Sp. z o. o.
state: Iodzkie
city: Bydgoszcz
country: Poland
facility: Centrum Endoskopii Zabiegowej, Poradnia Chorob Jelitowych
state: Kujawsko-pomorskie
city: Bydgoszcz
country: Poland
facility: Gabinet Lekarski - Janusz Rudzinski
state: Kujawsko-pomorskie
city: Warszawa
country: Poland
facility: Klinika Chorob Wewnetrznych i Gastroenterologii z Pododdzialem Leczenia Nieswoistych Chorob
state: Mazowieckie
city: Bialystok
country: Poland
facility: Oddzial Chorob Wewnetrznych i Gastroenterologii, SP ZOZ Wojewodzki Szpital
state: Podlaskie
city: Tychy
country: Poland
facility: H-T. Centrum Medyczne - ENDOTERAPIA
state: Slaskie
city: Krakow
country: Poland
facility: Gabinet Endoskopii Przewodu Pokarmowego
city: Lodz
country: Poland
facility: Oddzial Kliniczny Gastroenterologii Ogolnej i Onkologicznej, Uniwersytecki Szpital Kliniczny nr
city: Sopot
country: Poland
facility: Endoskopia SP. Z O.O.
city: Warszawa
country: Poland
facility: NZOZ Vivamed
city: Wroclaw
country: Poland
facility: Lexmedica
city: Timisoara
country: Romania
facility: Cabinet Particular Policlinic Algomed SRL
state: Timis
city: Bucuresti
country: Romania
facility: Spitalul Universitar de Urgenta Bucharest, Medicina Interna II Gastroenterologie
city: Moscow
country: Russian Federation
facility: Federal State Budgetary Institution "State Scientific Centre of Coloproctology n.a. A.N. Ryzhikh"
city: Moscow
country: Russian Federation
facility: State budget Healthcare Institution Moscow regional scientific research clinical institute
city: Nizhniy Novgorod
country: Russian Federation
facility: State budget Institution of Healthcare Nizhniy Novgorod Regional Clinical Hospital named after N. A.
city: Novosibirsk
country: Russian Federation
facility: Municipal Budget Institution of Healthcare of Novosibirsk
city: Novosibirsk
country: Russian Federation
facility: Federal State Budgetary Institution Scientific Research Institute of Physiology and Fundamental
city: Novosibirsk
country: Russian Federation
facility: FSBI "Scientific Research Institute of Physiology and Fundamental Medicine"
city: Samara
country: Russian Federation
facility: Non-State Healthcare Institution "Road Clinical Hospital at the station Samara"
city: Samara
country: Russian Federation
facility: Limited Liability Company Medical Company "Hepatolog"
city: Samara
country: Russian Federation
facility: Samara Diagnostic center, X-ray Department
city: Yaroslavl
country: Russian Federation
facility: State budget institution of healthcare of Yaroslavl region Regional clinical hospital
city: Belgrade
country: Serbia
facility: Military Medical Academy
state: Central Serbia
city: Belgrade
country: Serbia
facility: Clinical Centre of Serbia Clinic for Gastroenterology and Hepatology
city: Belgrade
country: Serbia
facility: Clinical Hospital Center Zvezdara - Clinic for Gastroenterology and Hepatology
city: Kragujevac
country: Serbia
facility: Clinical Centre of Kragujevac Clinic for Gastroenterology and Hepatology
city: Novi Sad
country: Serbia
facility: Clinical Centre of Vojvodina Emergency Internal Medicine Division
city: Novi Sad
country: Serbia
facility: Clinical Centre of Vojvodina, Clinic for Gastroenterology and Hepatology
city: Zrenjanin
country: Serbia
facility: General Hospital Djordje Joanovic
city: Bratislava
country: Slovakia
facility: Medak s.r.o.
city: Nitra
country: Slovakia
facility: "KM Management spol. s.r.o.Gastroenterologicke a hepatologicke centrum Nitra
city: Nove Mesto nad Vahom
country: Slovakia
facility: Poliklinika Libris, Synergy group, a.s.,
city: Presov
country: Slovakia
facility: Gastro I., s.r.o.
city: Johannesburg
country: South Africa
facility: Chris Hani Baragwanath Academic Hospital
state: Gauteng
city: Cape Town
country: South Africa
facility: Panorama Medi-Clinic
state: Western CAPE
city: Cape Town
country: South Africa
facility: Louis Leipoldt Medical Centre
state: Western CAPE
city: Cape Town
country: South Africa
facility: Dr JP Wright
state: Western CAPE
city: Paarl
country: South Africa
facility: Endocare Research Centre
state: Western CAPE
city: L'Hospitalet de Llobregat
country: Spain
facility: Hospital Universitario de Bellvitge
state: Barcelona
city: Fuenlabrada
country: Spain
facility: Hospital Universitario de Fuenlabrada
state: Madrid,
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial de Barcelona
city: Barcelona
country: Spain
facility: Corporacio Sanitaria Parc Tauli
city: Madrid
country: Spain
facility: Hospital Universitario de La Princesa
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital
city: Chernivtsi
country: Ukraine
facility: Regional Municipal Institution "Chernivtsi Regional Clinical Hospital"
city: Chernivtsi
country: Ukraine
facility: Regional Municipal Institution 'Chernivtsi Regional Clinical Hospital'
city: Dnipropetrovsk
country: Ukraine
facility: SI 'Institute of Gastroenterology of the NAMS of Ukraine', Dep.-nt of Stomach and Duodenum diseases
city: Kharkiv
country: Ukraine
facility: Municipal Healthcare Institution Kharkiv City Clinical Hospital #2
city: Kharkiv
country: Ukraine
facility: State Institution "L.T. Malaya Therapy Institute of NAMS of Ukraine"
city: Kyiv
country: Ukraine
facility: Kyiv Municipal Clinical Hospital #18, Proctology Department
city: Lviv
country: Ukraine
facility: LTD "St. Paraskeva Medical Center"
city: Lviv
country: Ukraine
facility: Municipal City Clinical Hospital of the Emergency Medical Care, 1-st Therapy Department of hospital,
city: Odesa
country: Ukraine
facility: Municipal Institution "Odesa Regional Clinical Hospital", polyclinic department
city: Odesa
country: Ukraine
facility: "Odesa Clinical Hospital for Railway ""Branch of ""Healthcare center of Private JSC ""Ukrainian
city: Uzhgorod
country: Ukraine
facility: CI of Uzhgorod Regional Rada Uzhgorod Central Regional Hospital". Therapy Department. SHEI Uzhgorod
city: Vinnytsia
country: Ukraine
facility: Vinnytsia Regional Clinical Hospital for War Veterans, Therapeutics Dept. No. 2
city: Zaporizhzhia
country: Ukraine
facility: Minicipal Institution City Hospital #7, Therapeutic Department,
city: Bristol
country: United Kingdom
facility: Bristol Royal Infirmary
state: England
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital - Cambridge University Hospitals NHS Foundation Trust
state: England
city: Harrow
country: United Kingdom
facility: The North West London Hospitals NHS Trust
state: Middlesex
city: Norwich
country: United Kingdom
facility: Norfolk and Norwich University Hospitals NHS Foundation Trust
state: Norfolk
city: London
country: United Kingdom
facility: UCLH NIHR Clinical Research Facility
state: W1t 7ha
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
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