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Study to Compare Oral PF-06651600, PF-06700841 and Placebo in Subjects With Moderate to Severe Ulcerative Colitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02958865
Recruitment Status : Recruiting
First Posted : November 8, 2016
Last Update Posted : October 9, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
The purpose of this study is to determine whether PF-06651600 and PF-06700841 are effective in treatment of moderate to severe ulcerative colitis.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Drug: PF-06651600 or Placebo Drug: PF-06700841 or Placebo Drug: PF-06700841 Drug: PF-06651600 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A PHASE 2B, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL GROUP, DOSE RANGING STUDY OF ORAL PF-06651600 AND PF-06700841 AS INDUCTION AND CHRONIC THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS
Actual Study Start Date : February 3, 2017
Estimated Primary Completion Date : December 6, 2020
Estimated Study Completion Date : June 19, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PF-06651600 Drug Dose Level 1
Delivered orally for 8 weeks
Drug: PF-06651600 or Placebo
Delivered orally for 8 weeks.

Experimental: PF-06651600 Drug Dose Level 2
Delivered orally for 8 weeks
Drug: PF-06651600 or Placebo
Delivered orally for 8 weeks.

Experimental: PF-06651600 Drug Dose Level 3
Delivered orally for 8 weeks.
Drug: PF-06651600 or Placebo
Delivered orally for 8 weeks.

Placebo Comparator: PF-06651600 Placebo
Delivered orally for 8 weeks.
Drug: PF-06651600 or Placebo
Delivered orally for 8 weeks.

Experimental: PF-06700841 Drug Dose Level 1
Delivered orally for 8 weeks
Drug: PF-06700841 or Placebo
Delivered orally for 8 weeks.

Experimental: PF-06700841 Drug Dose Level 2
Delivered orally for 8 weeks.
Drug: PF-06700841 or Placebo
Delivered orally for 8 weeks.

Experimental: PF-06700841 Drug Dose Level 3
Delivered orally for 8 weeks.
Drug: PF-06700841 or Placebo
Delivered orally for 8 weeks.

Placebo Comparator: PF-06700841 Placebo
Delivered orally for 8 weeks.
Drug: PF-06700841 or Placebo
Delivered orally for 8 weeks.

Experimental: PF-06651600 Drug Dose Level 4
Delivered orally for 24 weeks.
Drug: PF-06651600
Delivered orally for 24 weeks.

Experimental: PF-06700841 Drug Dose Level 4
Delivered orally for 24 weeks.
Drug: PF-06700841
Delivered orally for 24 weeks.




Primary Outcome Measures :
  1. Change from baseline in Total Mayo Score [ Time Frame: Baseline and Week 8 ]

Secondary Outcome Measures :
  1. Proportion of subjects achieving remission based on total Mayo score [ Time Frame: Week 8 ]
    Remission excludes friability and is based on total Mayo score of less than/equal to 2 with no individual subscore greater than 1 at Week 8.

  2. Proportion of subjects in remission based on total Mayo score [ Time Frame: Week 32 ]
    Remission excludes friability and is based on total Mayo score of less than/equal to 2 with no individual subscore greater than 1 at week 32.

  3. Proportion of subjects achieving improvement in endoscopic appearance [ Time Frame: Week 8 and 32 ]
    Improvement of endoscopic appearance is defined as a Mayo endoscopic subscore of less than/equal to 1

  4. Proportion of subjects achieving clinical response [ Time Frame: Week 8 ]
    Clinical response is defined as a decrease from baseline in total Mayo score of at least 3 points and at least 30%, with an accompanying decrease in the subscore for rectal bleeding of at least 1 point or absolute subscore for rectal bleeding of 0 or 1.

  5. Proportion of subjects in endoscopic remission [ Time Frame: Week 8 ]
    Endoscopic remission is defined as an endoscopic subscore of 0.

  6. Proportion of subjects in symptomatic remission [ Time Frame: Week 8 ]
    Symptomatic remission is defined as a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point, and both rectal bleeding and stool frequency subscores of 0.

  7. Proportion of subjects achieving deep remission [ Time Frame: Week 8 ]
    Deep remission is defined as a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a 0 on both endoscopic and rectal bleeding subscores.

  8. Partial Mayo Scores and changes from baseline [ Time Frame: Weeks 2, 4 and 8 ]
  9. Change from baseline in total Mayo score [ Time Frame: Week 8 ]
  10. Change from baseline in total Mayo score [ Time Frame: Week 32 ]
  11. Scores and changes from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) total score and domains [ Time Frame: Weeks 4 and 8 ]
    IBDQ domains include Bowel Symptoms, Systemic Symptoms, Emotional Function and Social Function.

  12. Proportion of subjects with IBDQ total score greater than/equal to 170. [ Time Frame: Weeks 4 and 8 ]
  13. Proportion of subjects with greater than/equal to 16 point increase in IBDQ total score from baseline [ Time Frame: Weeks 4 and 8 ]
  14. Proportion of subjects with improvement in IBDQ bowel symptom domain [ Time Frame: Weeks 4 and 8 ]
    Improvement is defined as an increase of at least 1.2 points from baseline in average score among IBDQ bowel symptom domain (items 1, 5, 9, 13, 17, 20, 22, 24, 26, 29).

  15. Scores and changes from baseline in SF-36 v2 [ Time Frame: Weeks 4 and 8 ]
    SF-36 physical and mental component summary scores: PCS and MCS, and 8 domain scores.

  16. Scores and changes from baseline in EuroQoL-5 Dimensions [ Time Frame: Weeks 4 and 8 ]
  17. Incidence of serious infections [ Time Frame: Baseline through week 36 ]
    Serious infections are treated infections that require parenteral antimicrobial therapy and present with positive pre-treatment culture AND EITHER require hospitalization for treatment OR meet other criteria that require the infection to be classified as an SAE.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of ulcerative colitis for greater than/equal to 3 months.
  • Moderate to severe active ulcerative colitis
  • Inadequate response to, loss of response to, or intolerance to at least one conventional therapy for UC.

Exclusion Criteria:

  • Pregnant or breastfeeding
  • Clinical findings suggestive of Crohn's Disease
  • History of bowel surgery within 6 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02958865


Contacts
Layout table for location contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

  Hide Study Locations
Locations
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United States, Alabama
Dothan Surgery Center Recruiting
Dothan, Alabama, United States, 36301
Gut P.C., dba Digestive Health Specialists of the Southeast Recruiting
Dothan, Alabama, United States, 36305
United States, California
Brighton Surgical Center Recruiting
Beverly Hills, California, United States, 90210
UCSD Investigational Drug Services Not yet recruiting
La Jolla, California, United States, 92037
UCSD Perlman Medical Offices Not yet recruiting
La Jolla, California, United States, 92037
UCSD Thorntorn Hospital Not yet recruiting
La Jolla, California, United States, 92037
UCSD Altman Clinical and Transitional Research Institute Not yet recruiting
La Jolla, California, United States, 92093
Long Beach Clinical Trials Services Inc. Recruiting
Long Beach, California, United States, 90806
Entertainment Medical Group Recruiting
Los Angeles, California, United States, 90036
Southern California Research Institute Medical Group/West Gastroenterology Medical Group/Airport En- Recruiting
Los Angeles, California, United States, 90045
Gastrointestinal Biosciences Recruiting
Los Angeles, California, United States, 90067
Clinical Application Laboratories, INC. Recruiting
San Diego, California, United States, 92103
San Diego Endoscopy Center Recruiting
San Diego, California, United States, 92103
Medical Associates Research Group Recruiting
San Diego, California, United States, 92123
United States, Colorado
Front Range Endoscopy Center Recruiting
Colorado Springs, Colorado, United States, 80903
Peak Gastroenterology Associates Recruiting
Colorado Springs, Colorado, United States, 80907
United States, Connecticut
Bristol Hospital Recruiting
Bristol, Connecticut, United States, 06010
Connecticut Clinical Research Institute Recruiting
Bristol, Connecticut, United States, 06010
Central Connecticut Endoscopy Center Recruiting
Plainville, Connecticut, United States, 06062
United States, Florida
Gastro Florida Recruiting
Clearwater, Florida, United States, 33756
West Coast Endoscopy Center Recruiting
Clearwater, Florida, United States, 33756
Gastro Florida Recruiting
Clearwater, Florida, United States, 33762
Bayonet Point Surgery & Endoscopy Not yet recruiting
Hudson, Florida, United States, 34667
University of Miami Hospital and Clinics Recruiting
Miami, Florida, United States, 33136
University of Miami Hospital Recruiting
Miami, Florida, United States, 33136
Advanced Research Institute, Inc. Not yet recruiting
New Port Richey, Florida, United States, 34653
Millenia Surgery Center Terminated
Orlando, Florida, United States, 32811
HMD Research LLC Terminated
Orlando, Florida, United States, 32819
Orlando Gastroenterology, PA Terminated
Orlando, Florida, United States, 32835
United States, Illinois
Illinois Gastroenterology Group Not yet recruiting
Arlington Heights, Illinois, United States, 60005
Southwest Gastroenterology Recruiting
Oak Lawn, Illinois, United States, 60453
Avicenna Clinical Research Recruiting
Palos Heights, Illinois, United States, 60463
United States, Louisiana
CroNOLA, LLC Not yet recruiting
Houma, Louisiana, United States, 70360
Gulf Coast Surgical Center Not yet recruiting
Houma, Louisiana, United States, 70360
United States, Maryland
Chevy Chase Endoscopy Center Recruiting
Chevy Chase, Maryland, United States, 20815
Feldman ENT Recruiting
Chevy Chase, Maryland, United States, 20815
MGG Group Co. Inc., Chevy Chase Clinical Research Recruiting
Chevy Chase, Maryland, United States, 20815
Cascades Endoscopy Center Recruiting
Columbia, Maryland, United States, 21045
Gastro Center of Maryland Recruiting
Columbia, Maryland, United States, 21045
Capitol Research Recruiting
Rockville, Maryland, United States, 20850
United States, Massachusetts
Massachusetts General Hospital - Chron's and Colitis Center Not yet recruiting
Boston, Massachusetts, United States, 02114
Massachusetts General Hospital-Clinical Trials Pharmacy Not yet recruiting
Boston, Massachusetts, United States, 02114
Massachusetts General Hospital-Crohn's and Colitis Center Not yet recruiting
Boston, Massachusetts, United States, 02114
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Brigham and Women's Hospital Recruiting
Chestnut Hill, Massachusetts, United States, 02467
UMass Memorial Medical Center Recruiting
Worcester, Massachusetts, United States, 01655
University of Massachusetts Medical School Recruiting
Worcester, Massachusetts, United States, 01655
United States, New York
Northwell Health, Division of Gastroenterology Not yet recruiting
Great Neck, New York, United States, 11021
NYU Langone Long Island Clinical Research Associates Recruiting
Great Neck, New York, United States, 11021
NYU Langone Nassau Gastroenterology Associates Recruiting
Great Neck, New York, United States, 11021
North Shore University Hospital Not yet recruiting
Manhasset, New York, United States, 11030
The Feinstein Institute for Medical Research Not yet recruiting
Manhasset, New York, United States, 11030
Concorde medical Group, PLLC Terminated
New York, New York, United States, 10016
Kips Bay Endoscopy Center Terminated
New York, New York, United States, 10016
New York University Langone Medical Center Active, not recruiting
New York, New York, United States, 10016
NYU Clinical Cancer Center Active, not recruiting
New York, New York, United States, 10016
NYU Langone Medical Center Active, not recruiting
New York, New York, United States, 10016
NYU Medical Science Building Active, not recruiting
New York, New York, United States, 10016
Weill Cornell Medical College Recruiting
New York, New York, United States, 10021
New York Presbyterian Hospital-Weill Cornell Medical College Investigational Pharmacy Recruiting
New York, New York, United States, 10065
New York Presbyterian Hospital-Weill Cornell Medical College Recruiting
New York, New York, United States, 10065
Weill Cornell Medical College-New York Presbyterian Hospital Recruiting
New York, New York, United States, 10065
University of Rochester Medical Center Terminated
Rochester, New York, United States, 14642
United States, North Carolina
UNC Hospitals Recruiting
Chapel Hill, North Carolina, United States, 27514
UNC Hospitals Endoscopy Center at Meadowmont Recruiting
Chapel Hill, North Carolina, United States, 27517
University of North Carolina at Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599-7064
University of North Carolina at Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599-7080
United States, Oklahoma
Digestive Disease Specialists, Inc. Not yet recruiting
Oklahoma City, Oklahoma, United States, 73112
United States, Tennessee
Gastro One Recruiting
Germantown, Tennessee, United States, 38138
Vanderbilt University Medical Center-IBD Clinic Recruiting
Nashville, Tennessee, United States, 37212-1375
Vanderbilt university medical Center Recruiting
Nashville, Tennessee, United States, 37212-1610
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232-5543
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232-7610
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
United States, Texas
Parkland Health and Hospital System Recruiting
Dallas, Texas, United States, 75235
HRMD Research Not yet recruiting
Dallas, Texas, United States, 75240
UT Southwestern Medical Center - CRU Aston Recruiting
Dallas, Texas, United States, 75390-9184
UT Southwestern Medical Center-Clements University Hospital Recruiting
Dallas, Texas, United States, 75390
UT Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Baylor College of Medicine-Baylor Medical Center Recruiting
Houston, Texas, United States, 77030
Baylor St. Luke's Medical Center Endoscopy-McNair Campus Recruiting
Houston, Texas, United States, 77030
Gulf Coast Research Group Recruiting
Houston, Texas, United States, 77098
Lonestar Endoscopy, LLP Recruiting
Keller, Texas, United States, 76248
Sagact, Pllc. Not yet recruiting
San Antonio, Texas, United States, 78229
Sagact, Pllc Not yet recruiting
San Antonio, Texas, United States, 78229
Lonestar Endoscopy, LLP Recruiting
Southlake, Texas, United States, 76092
Texas Diegestive Disease Consultants Recruiting
Southlake, Texas, United States, 76092
Texas Digestive Disease Consultants Recruiting
Southlake, Texas, United States, 76092
DM Clinical Research Recruiting
Tomball, Texas, United States, 77375
United States, Virginia
Verity Research Recruiting
Fairfax, Virginia, United States, 22031
Blue Ridge Medical Research Not yet recruiting
Lynchburg, Virginia, United States, 24502
McGuire DMVA Recruiting
Richmond, Virginia, United States, 23249
United States, Washington
University of Washington Active, not recruiting
Seattle, Washington, United States, 98195
Austria
AKH Wien Universitaetsklinik fuer Innere Medizin III Recruiting
Wien, Austria, 1090
Bulgaria
"Medical Center-1- Sevlievo" EOOD Recruiting
Sevlievo, Gabrovo, Bulgaria, 5400
MHAT Sv. Ivan Rilski - Gorna Oryahovitsa EOOD Recruiting
Gorna Oryahovitsa, Veliko Tarnovo, Bulgaria, 5100
"MHAT-Blagoevgrad" AD Recruiting
Blagoevgrad, Bulgaria, 2700
MHAT Dobrich AD Recruiting
Dobrich, Bulgaria, 9300
MC Hipocrat-2000 OOD Not yet recruiting
Haskovo, Bulgaria, 6300
MHAT Prof. Dr. Paraskev Stoyanov AD Recruiting
Lovech, Bulgaria, 5500
UMHAT "Dr Georgi Stranski" EAD Recruiting
Pleven, Bulgaria, 5800
Medical Center Vitadar Consult OOD Recruiting
Ruse, Bulgaria, 7000
SHATPPD dr. Dimitar Gramatikov - Ruse EOOD Recruiting
Ruse, Bulgaria, 7002
"MC Asklepion - researches in human medicine"" EOOD Recruiting
Sofia, Bulgaria, 1303
"Acibadem City Clinic UMHAT" EOOD Recruiting
Sofia, Bulgaria, 1784
Canada, Quebec
CIUSSS de l'Est-de-l'Ile-de-Montreal Installation Hopital Maisonneuve-Rosemont Not yet recruiting
Montreal, Quebec, Canada, H1T 2M4
Czechia
Hepato-Gastroenterologie HK, s.r.o. Recruiting
Hradec Kralove, Czechia, 50012
Medialpharma s.r.o. Recruiting
Hradec Kralove, Czechia, 50012
Vseobecna fakultni nemocnice Recruiting
Praha 2, Czechia, 128 08
Všeobecná fakultní nemocnice v Praze Recruiting
Praha 2, Czechia, 128 08
EGK s.r.o., Sanatorium svaté Anny Not yet recruiting
Praha 3, Czechia, 130 00
Lékárna Sv. Anna Not yet recruiting
Praha 3, Czechia, 130 00
Fakultní nemocnice v Motole Not yet recruiting
Praha 5, Czechia, 150 06
Lekarna Recruiting
Slany, Czechia, 274 01
Nemocnice Slany, p.o. Recruiting
Slany, Czechia, 274 01
Nemocnice Strakonice, a.s., interni oddeleni Recruiting
Strakonice, Czechia, 386 01
Ustavni lekarna Recruiting
Strakonice, Czechia, 38601
Krajska zdravotni, a.s., Masarykova nemocnice Usti nad Labem, o.z. Recruiting
Usti nad Labem, Czechia, 40113
Krajská zdravotní a.s., Masarykova nemocnice Ústí nad Labem, o. z. Recruiting
Ústí nad Labem, Czechia, 401 13
Denmark
Aarhus University Hospital Recruiting
Aarhus N, Denmark, 8200
Nordsjaellands Hospital Frederikssund Recruiting
Frederikssund, Denmark, 3600
Nordsjaellands Hospital Hillerod Recruiting
Hillerod, Denmark, 3400
Amager og Hvidovre Hospital Recruiting
Hvidovre, Denmark, 2650
Odense Universitetshospital Recruiting
Odense, Denmark, 5000
Georgia
Research institute of Clinical Medicine Recruiting
Tbilisi, Georgia, 0112
The First University Clinic of TSMU Recruiting
Tbilisi, Georgia, 0141
David Tatishvili Medical Center Recruiting
Tbilisi, Georgia, 0186
Germany
Paian MED Research GmbH Recruiting
Berlin, Germany, 10318
Gastrostudien GbR Recruiting
Berlin, Germany, 10825
Krankenhaus Waldfriede e.V. Recruiting
Berlin, Germany, 14163
Universitaetsklinikum Bonn Recruiting
Bonn, Germany, 53127
MVZ Dachau - Patientenzentrum Recruiting
Dachau, Germany, 85221
MVZ Dachau Recruiting
Dachau, Germany, 85221
Asklepios Westklinikum Hamburg Terminated
Hamburg, Germany, 22559
Universitaetsklinikum Schleswig-Holstein Recruiting
Kiel, Germany, 24105
Eugastro GmbH Recruiting
Leipzig, Germany, 04103
Universitaetsklinikum Ulm Recruiting
Ulm, Germany, 89081
Hungary
Bekes Megyei Kozpontti Korhaz, Rethy Pal Tagkorhaz Recruiting
Bekescsaba, Hungary, 5600
Szent Margit Korhaz Gasztroenterologiai Osztaly Recruiting
Budapest, Hungary, 1032
Semmelweis Egyetem, II. Belgyogyaszati Klinika Recruiting
Budapest, Hungary, 1088
Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak I. Belgyogyaszati Gasztroenterologiai Osztaly Recruiting
Budapest, Hungary, 1125
Pannonia Maganorvosi Centrum Recruiting
Budapest, Hungary, 1136
Debreceni Egyetem II. sz. Belgyogyaszati Klinika Recruiting
Debrecen, Hungary, 4032
Borsod-Abauj-Zemplen Megyei Kozponti Korhaz Recruiting
Miskolc, Hungary, 3526
Tolna Megyei Balassa Janos Korhaz Recruiting
Szekszard, Hungary, 7100
Javorszky Odon Korhaz, Gasztroenterologia Recruiting
Vac, Hungary, 2600
Israel
Clalit Health Services Recruiting
Bat-Yam, Israel, 5962025
Pharmacy Services Recruiting
Bat-Yam, Israel, 5962025
Pharmacy Services Not yet recruiting
Holon, Israel, 5810001
The E. Wolfson Medical Center Not yet recruiting
Holon, Israel, 5810001
Pharmacy Services Recruiting
Jerusalem, Israel, 9103102
Shaare Zedek Medical Center Recruiting
Jerusalem, Israel, 9103102
Diabetes and Endocrinology Unit Recruiting
Tel Aviv, Israel, 6203854
Migdal Hamea Clinic Recruiting
Tel Aviv, Israel, 6203854
Italy
IRCCS "Saverio de Bellis" Not yet recruiting
Castellana Grotte, Bari, Italy, 70013
AOU Sant'Orsola-Malpighi Recruiting
Bologna, BO, Italy, 40138
Istituto Clinico Humanitas Recruiting
Rozzano, Milan (MI), Italy, 20089
ASST Rhodense - Ospedale di Circolo di Rho Recruiting
Rho, Milano (MI), Italy, 20017
Azienda Ospedaliero Universitaria Pisana Recruiting
Pisa, PI, Italy, 56124
Policlinico Universitario Campus Biomedico Recruiting
Roma, RM, Italy, 00128
AOU Policlinico di Modena Recruiting
Modena, Italy, 41124
Azienda Ospedaliera di Padova Recruiting
Padova, Italy, 35128
Azienda Sanitaria Universitaria Integrata Udine Not yet recruiting
Udine, Italy, 33010
Korea, Republic of
Kyungpook National University Hospital Recruiting
Daegu, Korea, Republic of, 41944
Keimyung University Dongsan Hospital Recruiting
Daegu, Korea, Republic of, 42601
Severance Hospital, Yonsei University Health System Recruiting
Seoul, Korea, Republic of, 03722
Kangbuk Samsung Hospital Recruiting
Seoul, Korea, Republic of, 04516
The Catholic University of Korea, Seoul St. Mary's Hospital Recruiting
Seoul, Korea, Republic of, 06591
Netherlands
Amphia Ziekenhuis Recruiting
Breda, Netherlands, 4818 CK
Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Wojewodzki Szpital Zespolony Recruiting
Bialystok, Poland, 15-950
Uniwersyteckie Centrum Kliniczne im. Prof. Kornela Gibinskiego SUM Not yet recruiting
Katowice, Poland, 40-752
ETG Kielce Recruiting
Kielce, Poland, 25-355
Gastromed Sp. z o.o. Recruiting
Lublin, Poland, 20-582
Ai Centrum Medyczne Sp. Z O.O. Sp.K. Recruiting
Poznan, Poland, 61-113
KO-MED Centra Kliniczne Pulawy Recruiting
Pulawy, Poland, 24-100
ENDOSKOPIA Sp. z o. o. Recruiting
Sopot, Poland, 81-756
H-T. Centrum Medyczne Recruiting
Tychy, Poland, 43-100
Centrum Zdrowia MDM Active, not recruiting
Warszawa, Poland, 00-635
Centrum Diagnostyczno-Lecznicze Barska Sp. z o. o. Recruiting
Wloclawek, Poland, 87-800
Melita Medical Sp z o.o. Recruiting
Wroclaw, Poland, 50-449
Centrum Badan Klinicznych, Osrodek Badan Wczesnej Fazy Recruiting
Wroclaw, Poland, 51-162
Lexmedica Recruiting
Wroclaw, Poland, 53-114
EMC Instytut Medyczny S.A., Szpital Specjalistyczny EuroMediCare z Przychodnia Recruiting
Wroclaw, Poland, 54-144
Romania
Spitalul Universitar de Urgenta Militar Central "Dr. Carol Davila" Bucuresti Recruiting
Bucuresti, Sector 1,, Romania, 010825
S.C. Cabinet Particular Policlinic Algomed SRL Recruiting
Timisoara, Timis, Romania, 300002
Russian Federation
FSAEI HE I.M.Sechenov 1st Moscow State Medical University of the MoH of the RF (Sechenov University) Recruiting
Moscow, Russian Federation, 119048
FSAEI HE I.M.Sechenov 1st Moscow State Medical University of the MoH of the RF (Sechenov University) Recruiting
Moscow, Russian Federation, 119435
SBIH of Nizhegorodskaya Region "Nizhegorodskaya Regional Clinical Hospital n.a. N.A. Semashko" Not yet recruiting
Nizhny Novgorod, Russian Federation, 603126
Limited Liability Company "Medicinsky Center SibNovoMed" Not yet recruiting
Novosibirsk, Russian Federation, 630005
Novosibirskiy Gastrocenter Not yet recruiting
Novosibirsk, Russian Federation, 630007
Federal State Budgetary Scientific Institution Recruiting
Novosibirsk, Russian Federation, 630117
FSBEI HE "Rostov State Medical University" of the Ministry of Healthcare of the Russian Federation Recruiting
Rostov-on-Don, Russian Federation, 344022
State Budgetary Institution of Ryazan Region "Regional Clinical Hospital" Recruiting
Ryazan, Russian Federation, 390039
RIAT Limited Liability Company (RIAT LLC) Recruiting
Saint-Petersburg, Russian Federation, 195220
Saint-Petersburg State Budgetary Healthcare Institution Recruiting
Saint-Petersburg, Russian Federation, 195257
Medical University REAVIZ Recruiting
Samara, Russian Federation, 443011
LLC Medical Company Hepatolog Not yet recruiting
Samara, Russian Federation, 443063
State Budgetary Institution of Healthcare Yaroslavl Regional Clinical Hospital Recruiting
Yaroslavl, Russian Federation, 150062
Serbia
Clinical Centre of Serbia, Clinic for Gastroenterology and Hepatology Recruiting
Belgrade, Serbia, 11000
Clinical Hospital Centre Zvezdara Clinic for Internal Diseases Recruiting
Belgrade, Serbia, 11000
Clinical Hospital Centre Bezanijska Kosa Clinic for Internal Medicine Recruiting
Belgrade, Serbia, 11080
Clinical Centre of Kragujevac Recruiting
Kragujevac, Serbia, 34000
Clinical Centre of Nis, Clinic for Gastroenterology and Hepatology Recruiting
Nis, Serbia, 18000
General Hospital Subotica Recruiting
Subotica, Serbia, 24000
Clinical Hospital Center Zemun Recruiting
Zemun, Belgrade, Serbia, 11080
General Hospital "Djordje Joanovic" Recruiting
Zrenjanin, Serbia, 23000
Slovakia
Abawi spol. s r.o Recruiting
Bratislava, Slovakia, 82107
Medak s.r.o. Recruiting
Bratislava, Slovakia, 851 01
Breznianske centrum gastroenterologie s.r.o. Recruiting
Brezno, Slovakia, 97701
Gastroenterologicka ambulancia MUDr. Peter Hegyi s.r.o. Recruiting
Malacky, Slovakia, 901 01
KM Management spol. s.r.o. Recruiting
Nitra, Slovakia, 949 01
MUDr. Frantisek Horvath Gastroenterologia Recruiting
Sahy, Slovakia, 93601
ENDOMED, s.r.o. Recruiting
Vranov nad Toplou, Slovakia, 093 01
Spain
Hospital Universitari de Bellvitge Recruiting
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
Hospital Universitario Marques de Valdecilla Recruiting
Santander, Cantabria, Spain, 39008
Hospital Universitario Donostia Recruiting
San Sebastian, Guipuzkoa, Spain, 20014
Hospital Universitario Fundacion Alcorcon Recruiting
Alcorcon, Madrid, Spain, 28922
Hospital Universitario Puerta de Hierro de Majadahonda Recruiting
Majadahonda, Madrid, Spain, 28222
Hospital Clinic de Barcelona Recruiting
Barcelona, Spain, 08036
Hospital General Universitario Gregorio Maranon Recruiting
Madrid, Spain, 28007
Hospital Universitario Virgen del Rocio Recruiting
Sevilla, Spain, 41013
Hospital Universitari i Politecnic La Fe Recruiting
Valencia, Spain, 46026
Turkey
Ankara Universitesi Tip Fakultesi, Ibn-i Sina Hastanesi, Ic Hastaliklari Anabilim Dali, Recruiting
Ankara, Turkey, 06100
Ankara Universitesi Tip Fakultesi, Ibn-i-Sina Hastanesi Recruiting
Ankara, Turkey, 06100
Hacettepe Universitesi Tip Fakultesi Recruiting
Ankara, Turkey, 06230
Ankara Universitesi Tip Fakultesi Cebeci Hastanesi Terminated
Ankara, Turkey, 06590
Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi Recruiting
Istanbul, Turkey, 34093
Istanbul Universitesi Istanbul Tıp Fakultesi Recruiting
Istanbul, Turkey, 34093
Istanbul Universitesi Cerrahpasa Tip Fakultesi Recruiting
Istanbul, Turkey, 34098
Erciyes Universitesi Tip Fakultesi Recruiting
Kayseri, Turkey, 38039
Kocaeli Universitesi Tip Fakultesi Recruiting
Kocaeli, Turkey, 41380
Mersin Universitesi Tip Fakultesi Hastanesi Recruiting
Mersin, Turkey, 33110
Bulent Ecevit Universitesi Tip Fakultesi Recruiting
Zonguldak, Turkey, 67600
Ukraine
Regional Consultative Polyclinic Recruiting
Chernivtsi, Ukraine, 58000
Regional Municipal Institution "Chernivtsi Regional Clinical Hospital", gastroenterology department, Recruiting
Chernivtsi, Ukraine, 58001
Municipal Non-Commercial Enterprise Municipal Clinical Hospital 2 Name Shalimov Kharkiv City Council Recruiting
Kharkiv, Ukraine, 61037
Municipal Institution "Kherson City Clinical Hospital n.a. Afanasiy and Olga Tropiny" Recruiting
Kherson, Ukraine, 73000
Private Enterprise of Private Manufacturing Company "Acinus", Medical and Diagnostic Center Recruiting
Kropyvnytskyi, Ukraine, 25006
Kyiv Municipal Clinical Hospital #18, Proctology Department Recruiting
Kyiv, Ukraine, 01030
Medical Center "Universal clinic Oberig" of "Kapital" LLC, Gastro center Recruiting
Kyiv, Ukraine, 03680
Lviv clinical hospital on Railway Transport of Health Care Center branch of PJSC Ukrainian Railway Recruiting
Lviv, Ukraine, 79007
Municipal City Clinical Hospital of Emergency Recruiting
Lviv, Ukraine, 79059
Municipal Institution "Odesa Regional Clinical Hospital" Recruiting
Odesa, Ukraine, 65025
Municipal Institution of Ternopil regional council Ternopil University Hospital Terminated
Ternopil, Ukraine, 46002
Municipal Institution "Uzhgorod Regional Hospital" Recruiting
Uzhgorod, Ukraine, 88009
Zakarpattia Regional Clinical Hospital n.a. A. Novak, Recruiting
Uzhgorod, Ukraine, 88018
Vinnytsia Regional Clinical Hospital n.a. M.I.Pyrohov Recruiting
Vinnytsia, Ukraine, 21018
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02958865     History of Changes
Other Study ID Numbers: B7981005
VIBRATO ( Other Identifier: Alias Study Number )
2016-003708-29 ( EudraCT Number )
First Posted: November 8, 2016    Key Record Dates
Last Update Posted: October 9, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pfizer:
Mayo score
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases