Clinical trial NCT01458574: A Study Of Oral CP-690,550 As A Maintenance Therapy For Ulcerative Colitis
Official title: A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Of Oral Cp-690,550 As A Maintenance Therapy In Subjects With Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ulcerative Colitis
Keywords: Janus kinase inhibitor
JAK 3 inhibitor
inflammatory bowel disease
ulcerative colitis
OCTAVE
CP-690
550
tofacitinib
Xeljanz
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-10-25
Enrollment: 593
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study proposes to assess whether compared to placebo, CP-690,550 is effective, safe, and tolerable maintenance therapy in subjects with Ulcerative Colitis (UC). The study proposes to assess whether compared to placebo, CP-690,550 maintenance therapy more effectively achieves mucosal healing and improves quality of life in subjects with UC.The study proposes to assess CP-690,550 pharmacokinetic exposure during maintenance therapy in subjects over the age of 18 years with UC.


Eligibility criteria: Inclusion Criteria:

* Subjects who met study entry criteria and completed 8-week induction treatment from Study A3921094 or A3921095
* Subjects who achieved clinical response in Study A3921094 or A3921095
* Women of childbearing potential must test negative for pregnancy prior to study enrollment
* Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
* Evidence of a personally signed and dated informed consent document(s) indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

Exclusion Criteria:

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

Primary outcomes:
measure: Percentage of Participants In Remission at Week 52
timeFrame: Week 52
Secondary outcomes:
measure: Percentage of Participants With Mucosal Healing at Week 52
timeFrame: Week 52
measure: Percentage of Participants With Sustained Steroid-Free Remission (Defined as Being in Remission and Steroid-Free at Both Week 24 and 52), Among Participants With Remission at Baseline
timeFrame: Week 24, 52
measure: Percentage of Participants in Remission at Week 24
timeFrame: Week 24
measure: Percentage of Participants in Sustained Remission
timeFrame: Week 24, 52
measure: Percentage of Participants With Mucosal Healing at Week 24
timeFrame: Week 24
measure: Percentage of Participants With Sustained Mucosal Healing
timeFrame: Week 24, 52
measure: Percentage of Participants With Mucosal Healing at Week 24 and 52, Among Participants With Mucosal Healing at Baseline
timeFrame: Week 24, 52
measure: Percentage of Participants With Sustained Mucosal Healing, Among Participants With Mucosal Healing at Baseline
timeFrame: Week 24, 52
measure: Percentage of Participants With Clinical Response at Week 24 and 52
timeFrame: Week 24, 52
measure: Percentage of Participants With Sustained Clinical Response
timeFrame: Week 24, 52
measure: Percentage of Participants in Clinical Remission at Week 24 and 52
timeFrame: Week 24, 52
measure: Percentage of Participants in Sustained Clinical Remission
timeFrame: Week 24, 52
measure: Percentage of Participants in Deep Remission at Week 24 and 52
timeFrame: Week 24, 52
measure: Percentage of Participants in Sustained Deep Remission
timeFrame: Week 24, 52
measure: Percentage of Participants in Symptomatic Remission at Week 24 and 52
timeFrame: Week 24, 52
measure: Percentage of Participants in Sustained Symptomatic Remission
timeFrame: Week 24, 52
measure: Percentage of Participants in Endoscopic Remission at Week 24 and 52
timeFrame: Week 24, 52
measure: Percentage of Participants in Sustained Endoscopic Remission
timeFrame: Week 24, 52
measure: Total Mayo Score at Baseline, Week 24 and 52
timeFrame: Baseline, Week 24, 52
measure: Change From Baseline in Total Mayo Score at Week 24 and 52
timeFrame: Baseline, Week 24, 52
measure: Percentage of Participants in Remission, Among Participants With Remission at Baseline
timeFrame: Week 24, 52
measure: Percentage of Participants in Sustained Remission, Among Participants With Remission at Baseline
timeFrame: Week 24, 52
measure: Percentage of Participants in Steroid-free Remission, Among Participants in Remission at Baseline
timeFrame: Week 24, 52
measure: Percentage of Participants in Steroid-Free Remission, Among Participants Receiving Steroids at Baseline
timeFrame: Week 24, 52
measure: Percentage of Participants in Sustained Steroid-Free Remission, Among Participants Receiving Steroids at Baseline
timeFrame: Week 24, 52
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Internal Medicine Center, LLC
state: Alabama
city: Mobile
country: United States
facility: Springhill Memorial Hospital (Endoscopy Only)
state: Alabama
city: La Jolla
country: United States
facility: UCSD Health System - Investigational Drug Pharmacy - Moores Cancer Center
state: California
city: La Jolla
country: United States
facility: UCSD Medical Center
state: California
city: Oceanside
country: United States
facility: Alliance Clinical Research
state: California
city: Palm Springs
country: United States
facility: Desert Advanced Imaging
state: California
city: Palm Springs
country: United States
facility: Erik Palmer, DO
state: California
city: Palm Springs
country: United States
facility: Homan A Zadeh, MD, MPH
state: California
city: Rancho Mirage
country: United States
facility: Hope Square Surgical Center
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: San Diego Endoscopy Center
state: California
city: San Diego
country: United States
facility: Sharp Rees-Stealy Medical Group
state: California
city: San Francisco
country: United States
facility: UCSF Endoscopy Unit at Mount Zion
state: California
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Bristol
country: United States
facility: Bristol Hospital
state: Connecticut
city: Bristol
country: United States
facility: Connecticut Clinical Research Foundation
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: Plainville
country: United States
facility: Central Connecticut Endoscopy Center
state: Connecticut
city: Crystal River
country: United States
facility: Citrus Surgery & Endoscopy Center (colonoscopy)
state: Florida
city: Inverness
country: United States
facility: Nature Coast Clinical Research
state: Florida
city: Inverness
country: United States
facility: Suncoast Endoscopy Center (colonoscopy)
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: Zephyhills
country: United States
facility: Florida Medical Clinic, P.A.
state: Florida
city: Zephyrhills
country: United States
facility: Florida Medical Clinic, P.A.
state: Florida
city: Alpharetta
country: United States
facility: Georgia Endoscopy Center
state: Georgia
city: Atlanta
country: United States
facility: GI Consultants
state: Georgia
city: Johns Creek
country: United States
facility: Emory Healthcare Heart Center
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: Suwanee
country: United States
facility: Johns Creek Diagnostic Center
state: Georgia
city: Topeka
country: United States
facility: Cotton-O'Neal Clinical Research Center Digestive Health
state: Kansas
city: Baltimore
country: United States
facility: Digestive Disease Associates, PA
state: Maryland
city: Baltimore
country: United States
facility: Gastrointestinal Diagnostic Center
state: Maryland
city: Catonsville
country: United States
facility: Digestive Disease Associates, PA
state: Maryland
city: Columbia
country: United States
facility: Howard County GIDC
state: Maryland
city: Ann Arbor
country: United States
facility: Saint Joseph Mercy Hospital - Inpatient Pharmacy
state: Michigan
city: Ann Arbor
country: United States
facility: East Ann Arbor Health and Geriatrics Center - UMHS
state: Michigan
city: Ann Arbor
country: United States
facility: University of Michigan Health Systems
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: 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: Utica
country: United States
facility: Utica Surgery Center (Endoscopy Only)
state: Michigan
city: Ypsilanti
country: United States
facility: Michigan Heart SJMH
state: Michigan
city: Ypsilanti
country: United States
facility: Huron Gastroenterology Associates
state: Michigan
city: Ypsilanti
country: United States
facility: Saint Joseph Mercy Hospital Outpatient Laboratory
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 Harbour Township
country: United States
facility: AGA Clinical Research Associates, LLC
state: New Jersey
city: Marlton
country: United States
facility: South Jersey Gastroenterology
state: New Jersey
city: Vorhees
country: United States
facility: The Endo Center at Voorhees
state: New Jersey
city: Great Neck
country: United States
facility: NYU Langone Long Island Clinical Research Associates
state: New York
city: Great Neck
country: United States
facility: NYU Langone Nassau Gastroenterology Associates
state: New York
city: New York
country: United States
facility: The Private Practice of Simon Lichtiger, MD
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 Medical Center
state: New York
city: New York
country: United States
facility: CUMC Research Pharmacy
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
state: Ohio
city: Mentor
country: United States
facility: Mentor Medical Campus
state: Ohio
city: Mentor
country: United States
facility: The Endoscopy Center of Lake County
state: Ohio
city: Lancaster
country: United States
facility: Regional Gastroenterology Associates of Lancaster, Ltd.
state: Pennsylvania
city: Austin
country: United States
facility: Professional Quality Research, Inc.- Austin Gastroenterology PA
state: Texas
city: Austin
country: United States
facility: Austin Endoscopy Center II
state: Texas
city: Austin
country: United States
facility: Austin Gastroenterology PA
state: Texas
city: Houston
country: United States
facility: Houston Hospital for Specialized Surgery (Endoscopy only)
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 (Drug Storage)
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: Digestive Health Specialists of Tyler
state: Texas
city: Salt Lake City
country: United States
facility: Alpine Medical Group
state: Utah
city: Salt Lake City
country: United States
facility: Wasatch Clinical Research
state: Utah
city: Salt Lake City
country: United States
facility: Wasatch Endoscopy Center
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: The Center for Digestive Health
state: Wisconsin
city: Milwaukee
country: United States
facility: Wisconsin Center for Advanced Research
state: Wisconsin
city: Concord
country: Australia
facility: Concord Repatriation General Hospital
state: New South Wales
city: Liverpool
country: Australia
facility: Liverpool Hospital
state: New South Wales
city: Box Hill
country: Australia
facility: Eastern Health-Box Hill Hospital
state: Victoria
city: Clayton
country: Australia
facility: Monash Medical Centre
state: Victoria
city: Wien
country: Austria
facility: AKH Wien, Universitaetsklinik fuer Innere Medizin III
state: Vienna
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: 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: Montreal General Hospital - McGill University Health 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 Coloproctología ICO S.A.S.
state: Antioquia
city: Zagreb
country: Croatia
facility: University Hospital Center Zagreb
city: Hradec Kralove
country: Czech Republic
facility: Hepato-Gastroenterologie HK, s.r.o.
city: Strakonice
country: Czech Republic
facility: Nemocnice Strakonice, a.s., Interni oddeleni
city: Usti nad Labem
country: Czech Republic
facility: Krajska zdravotni, a.s. Masarykova nemocnice v Usti nad Labem
city: Aalborg
country: Denmark
facility: Aalborg Hospital
city: Aarhus C
country: Denmark
facility: Aarhus University Hospital
city: Copenhagen NV
country: Denmark
facility: Bispebjerg Hospital
city: Hvidovre
country: Denmark
facility: Hvidovre Hospital
city: Odense C
country: Denmark
facility: Odense University Hospital
city: Tallinn
country: Estonia
facility: X-Ray Unit, East Tallinn Central Hospital
city: Tallinn
country: Estonia
facility: ECG Unit, Innomedica OU and Qualitas AS (ECG Only)
city: Tallinn
country: Estonia
facility: Innomedica OU
city: Tallinn
country: Estonia
facility: East Tallinn Central Hospital Internal Medical Clinic
city: Tallinn
country: Estonia
facility: ECG Unit of West Tallinn Central Hospital
city: Tallinn
country: Estonia
facility: West Tallinn Central Hospital
city: Tallinn
country: Estonia
facility: X- Ray Department of West Tallinn Central Hospital
city: Tallinn
country: Estonia
facility: X-Ray Department of West Tallinn Central Hospital
city: Tallinn
country: Estonia
facility: Mammograaf OU (Endoscopy Only)
city: Tallin
country: Estonia
facility: ECG Unit, East Tallinn Central Hospital
city: Amiens Cedex 1
country: France
facility: CHU Amiens PICARDIE - Hopital SUD
city: Bordeaux cedex
country: France
facility: Hopital Saint Andre
city: Clichy Cedex
country: France
facility: Hopital Beaujon
city: Nantes cedex 01
country: France
facility: Hotel-Dieu CHU Nantes
city: Paris cedex 12
country: France
facility: Hopital Saint Antoine - Service de Gastroenterologie
city: Paris
country: France
facility: Hopital Saint Louis - Service d'hepato-gastoenterologie
city: Paris
country: France
facility: Hopital Saint Louis
city: Reims cedex
country: France
facility: C.H.U. de Reims - Hôpital Robert Debré
city: Saint Priest en Jarez
country: France
facility: Hopital Nord
city: Kiel
country: Germany
facility: Universitaetsklinikum Schleswig-Holstein, Campus Kiel
state: Schlewig Holstein
city: Berlin
country: Germany
facility: Universitaetsmedizin Berlin, Charite Campus Virchow-Klinikum,
city: Halle
country: Germany
facility: Universitätsklinikum Halle
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Lüneburg
country: Germany
facility: Klinikum Lüneburg/Abteilung Gastroenterologie
city: Minden
country: Germany
facility: Gastroenterologische Gemeinschaftspraxis Minden
city: Ulm
country: Germany
facility: Universitaetsklinikum Ulm
city: Bekescsaba
country: Hungary
facility: Dr Rethy Pal Korhaz-Rendelointezet, III Belgyogyaszat
city: Budapest
country: Hungary
facility: Szent Margit Korhaz - III Belgyogyaszat
city: Budapest
country: Hungary
facility: Peterfy Sandor Utcai Korhaz Rendelointezet es Baleseti Kozpont
city: Budapest
country: Hungary
facility: Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak
city: Budapest
country: Hungary
facility: Pannonia Maganorvosi Centrum Kft.
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont, Belgyogyaszati Intezet Gasztroenterologiai Tanszek
city: Gyula
country: Hungary
facility: Bekes Megyei Pandy Kalman Korhaz III. Gasztroenterologiai Osztaly
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: Petah Tikva
country: Israel
facility: Rabin Medical Center, Beilinson campus
city: Rehovot
country: Israel
facility: Kaplan Medical Center
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas IRCSS
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: Sapporo
country: Japan
facility: Hokkaido P.W.F.A.C Sapporo-Kosei general Hospital
state: Hokkaido
city: Nishinomiya
country: Japan
facility: The Hospital of Hyogo College of Medicine
state: Hyogo
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: Takatsuki-shi
country: Japan
facility: Osaka Medical College Hospital
state: Osaka
city: Otsu-shi
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: Kitasato University Kitasato Institute Hospital
state: Tokyo
city: Shinagawa-ku
country: Japan
facility: NTT Medical Center Tokyo
state: Tokyo
city: Shinagawa-ku
country: Japan
facility: Showa University Hospital
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Keio University Hospital
state: Tokyo
city: Chiba
country: Japan
facility: Chiba University Hospital
city: Chiba
country: Japan
facility: Toho University Sakura Medical Center
city: Fukuoka
country: Japan
facility: Kurume University Hospital
city: Hiroshima
country: Japan
facility: Hiroshima University Hospital
city: Osaka
country: Japan
facility: Osaka City University Hospital
city: Guri-si
country: Korea, Republic of
facility: Hanyang University Guri Hospital
state: Gyeonggi-do
city: Seoul
country: Korea, Republic of
facility: KyungHee University Hospital
state: Republic of Korea
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: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital,
city: Riga
country: Latvia
facility: ECG room Clinic Linezers (ECG only) Riga East University Hospital
city: Riga
country: Latvia
facility: X-Ray Department, Clinic Linezers (radiology only)
city: Riga
country: Latvia
facility: Digestive Diseases Center GASTRO
city: Amsterdam
country: Netherlands
facility: VU University Medical Center (VUMC)
city: Amsterdam
country: Netherlands
facility: Academic Medical Centre
city: Groningen
country: Netherlands
facility: University Medical Center Groningen (UMCG)
city: Leiden
country: Netherlands
facility: Leiden University Medical Center (LUMC)
city: Milford
country: New Zealand
facility: Shakespeare Specialist Group
state: Auckland
city: Tauranga
country: New Zealand
facility: Tauranga Hospital
state: Bay of Plenty
city: Christchurch
country: New Zealand
facility: Christchurch Hospital
state: Canterbury Region
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: Wellington
country: New Zealand
facility: Pacific Radiology (X-rays only)
city: Wellington
country: New Zealand
facility: Bowen Hospital
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, Szpital Uniwersytecki nr 2 im
state: Kujawsko-pomorskie
city: Warszawa
country: Poland
facility: Klinika Chorob Wewnetrznych i Gastroenterologii z
state: Mazowieckie
city: Tychy
country: Poland
facility: H-T. Centrum Medyczne - ENDOTERAPIA
state: Slaskie
city: Bydgoszcz
country: Poland
facility: Gabinet Lekarski - Janusz Rudzinski
city: Krakow
country: Poland
facility: Gabinet Endoskopii Przewodu Pokarmowego
city: Lodz
country: Poland
facility: Oddzial Kliniczny Gastroenterologii Ogólnej i Onkologicznej, Uniwersytecki Szpital
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
city: Saratov
country: Russian Federation
facility: Municipal Institution of Healthcare City Clinical Hospital 12,
state: Russia
city: Moscow
country: Russian Federation
facility: Federal state budget institution "State scientific centre of coloproctology"
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: Federal state Institution "Sibirian regional Medical centre of Federal Medicobiologic Agency",
city: Novosibirsk
country: Russian Federation
facility: Municipal Budget Institution of Healthcare of Novosibirsk " City Clinical Hospital No 12"
city: Novosibirsk
country: Russian Federation
facility: State Budget Educational Institution of Higher Professional Education
city: Novosibirsk
country: Russian Federation
facility: Federal State Budgetary Institution "Scientific Research Institute of Physiology and Fundamental
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: 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: Clinical Centre of Serbia, Clinic for Gastroenterology and Hepatology
state: Serbia, Europe
city: Belgrade
country: Serbia
facility: Clinical Hospital Centre Zvezdara
city: Belgrade
country: Serbia
facility: Military Medical Academy Belgrade
city: Kragujevac
country: Serbia
facility: Clinical Centre of Kragujevac
city: Novi Sad
country: Serbia
facility: Clinical Centre of Vojvodina, Clinic for Gastroenterology and Hepatology
city: Novi Sad
country: Serbia
facility: Clinical Centre of Vojvodina, Emergency Internal Medicine Division
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.
city: Nove Mesto nad Vahom
country: Slovakia
facility: Aura SA, s.r.o.
city: Presov
country: Slovakia
facility: Gastro I., s.r.o.
city: Claremont
country: South Africa
facility: Dr John Philip Wright
state: Cape Town
city: Johannesburg
country: South Africa
facility: Chris Hani Baragwanath Academic Hospital
state: Gauteng
city: Cape Town
country: South Africa
facility: Panorama MediClinic
state: Western Cape
city: Cape Town
country: South Africa
facility: Louis Leipoldt Medical Centre
state: Western Cape
city: Western Cape
country: South Africa
facility: Endocare Research Centre
city: L'Hospitalet de Llobregat
country: Spain
facility: Hospital Universitari de Bellvitge, Servicio de Digestivo
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial de Barcelona
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario de Fuenlabrada
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital
city: Simferopol
country: Ukraine
facility: Internal Medicine Center of Crimean Republic Institution"Clinical Territorial Medical Community"
state: Ar Krym
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: Dniepropetrovsk
country: Ukraine
facility: State Institution "Institute of Gastroenterology of the National Academy of Medical Sciences of
city: Kharkiv
country: Ukraine
facility: Municipal Healthcare Institution Kharkiv City Clinical Hospital #2, Proctology Department
city: Kharkiv
country: Ukraine
facility: State Institution "National L.T. Malaya Therapy Institute of National Academy of
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: SI "Railway Hospital of the SI "Odesa Railway"", Polyclinic Department,
city: Odesa
country: Ukraine
facility: Municipal Institution "Odesa Regional Clinical Hospital"
city: Uzhgorod
country: Ukraine
facility: SI "District Clin. Hosp.of Uzhgorod station (STSA "Lviv Railway", Therapy Dep., SBHEI "Uzhgorod Nat.
city: Vinnytsia
country: Ukraine
facility: Vinnytsia Regional Clinical Hospital for Invalids of the Great Patriotic War, Therapy Department #2,
city: Zaporizhzhia
country: Ukraine
facility: Motor-Sich clinic, LLC
city: Zaporizhzhia
country: Ukraine
facility: Minicipal Institution City Hospital 7, Therapevtic Department,
city: Zaporizhzhia
country: Ukraine
facility: Municipal Institution "City Hospital #7", Zaporizhzhia State Medical University
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital-Cambridge University Hospitals NHS Foundation Trust
state: Cambridgeshire
city: Bristol
country: United Kingdom
facility: Department of Gastroenterology, Old Building
state: England
city: London
country: United Kingdom
facility: University College Hospital
state: Greater London
city: Harrow
country: United Kingdom
facility: NWLH NHS trust
state: Middlesex
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 Hospital
state: Norfolk
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
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