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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 : September 3, 2020
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 : October 28, 2020
Estimated Study Completion Date : May 12, 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
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
Hide Hide 203 study 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
Long Beach Clinical Trials Services Inc. Recruiting
Long Beach, California, United States, 90806
Southern California Research Institute Medical Group/West Gastroenterology Medical Group/Airport En- Recruiting
Los Angeles, California, United States, 90045
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
University of Miami Hospital and Clinics Active, not recruiting
Miami, Florida, United States, 33136
University of Miami Hospital Active, not recruiting
Miami, Florida, United States, 33136
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
Southwest Gastroenterology Recruiting
Oak Lawn, Illinois, United States, 60453
Avicenna Clinical Research Recruiting
Palos Heights, Illinois, United States, 60463
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
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Brigham and Women's Hospital Recruiting
Chestnut Hill, Massachusetts, United States, 02467
United States, New York
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. Recruiting
Oklahoma City, Oklahoma, United States, 73112
United States, Tennessee
Gastro One Active, not recruiting
Germantown, Tennessee, United States, 38138
United States, Texas
Parkland Health and Hospital System Recruiting
Dallas, Texas, United States, 75235
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 Active, not recruiting
Houston, Texas, United States, 77098
Lonestar Endoscopy, LLP Recruiting
Keller, Texas, United States, 76248
Sagact, Pllc. Recruiting
San Antonio, Texas, United States, 78229
Sagact, Pllc 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 Active, not recruiting
Fairfax, Virginia, United States, 22031
Blue Ridge Medical Research Recruiting
Lynchburg, Virginia, United States, 24502
McGuire DVAMC Active, not 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 Active, not recruiting
Wien, Austria, 1090
Bulgaria
"Medical Center-1- Sevlievo" EOOD Active, not recruiting
Sevlievo, Gabrovo, Bulgaria, 5400
"MHAT-Blagoevgrad" AD Active, not recruiting
Blagoevgrad, Bulgaria, 2700
MHAT Dobrich AD Active, not recruiting
Dobrich, Bulgaria, 9300
MC Hipocrat-2000 OOD Recruiting
Haskovo, Bulgaria, 6300
MHAT Prof. Dr. Paraskev Stoyanov AD Active, not recruiting
Lovech, Bulgaria, 5500
Medical Center Vitadar Consult OOD Active, not recruiting
Ruse, Bulgaria, 7000
SHATPPD dr. Dimitar Gramatikov - Ruse EOOD Recruiting
Ruse, Bulgaria, 7002
"MC Asklepion - researches in human medicine"" EOOD Active, not recruiting
Sofia, Bulgaria, 1303
"Acibadem City Clinic UMHAT" EOOD Active, not recruiting
Sofia, Bulgaria, 1784
Czechia
Hepato-Gastroenterologie HK, s.r.o. Recruiting
Hradec Kralove, Czechia, 50012
Medialpharma s.r.o. Recruiting
Hradec Kralove, Czechia, 50012
Fakultni nemocnice v Motole 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
Denmark
Nordsjaellands Hospital Frederikssund Recruiting
Frederikssund, Denmark, 3600
Nordsjaellands Hospital Hillerod Recruiting
Hillerod, Denmark, 3400
Nordsjaellands Hospital Hilleroed Recruiting
Hilleroed, Denmark, 3400
Amager og Hvidovre Hospital Recruiting
Hvidovre, Denmark, 2650
Odense Universitetshospital Active, not recruiting
Odense, Denmark, 5000
Georgia
Research institute of Clinical Medicine Recruiting
Tbilisi, Georgia, 0112
The First University Clinic of TSMU Recruiting
Tbilisi, Georgia, 0141
Germany
Paian MED Research GmbH Active, not recruiting
Berlin, Germany, 10318
Gastrostudien GbR Active, not recruiting
Berlin, Germany, 10825
Krankenhaus Waldfriede e.V. Active, not recruiting
Berlin, Germany, 14163
MVZ Dachau - Patientenzentrum Active, not recruiting
Dachau, Germany, 85221
MVZ Dachau Active, not recruiting
Dachau, Germany, 85221
Asklepios Westklinikum Hamburg Terminated
Hamburg, Germany, 22559
Universitaetsklinikum Schleswig-Holstein Active, not recruiting
Kiel, Germany, 24105
Eugastro GmbH Active, not recruiting
Leipzig, Germany, 04103
Hungary
Bekes Megyei Kozpontti Korhaz, Rethy Pal Tagkorhaz Recruiting
Bekescsaba, Hungary, 5600
Semmelweis Egyetem, II. Belgyogyaszati Klinika Recruiting
Budapest, Hungary, 1088
Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak I. Belgyogyaszati Gasztroenterologiai Osztaly Active, not recruiting
Budapest, Hungary, 1125
Pannonia Maganorvosi Centrum Active, not recruiting
Budapest, Hungary, 1136
Tolna Megyei Balassa Janos Korhaz Recruiting
Szekszard, Hungary, 7100
Javorszky Odon Korhaz, Gasztroenterologia Recruiting
Vac, Hungary, 2600
Israel
Clalit Health Services Active, not recruiting
Bat-Yam, Israel, 5962025
Pharmacy Services Active, not recruiting
Bat-Yam, Israel, 5962025
Pharmacy Services Active, not recruiting
Jerusalem, Israel, 9103102
Shaare Zedek Medical Center Active, not recruiting
Jerusalem, Israel, 9103102
Diabetes and Endocrinology Unit Active, not recruiting
Tel Aviv, Israel, 6203854
Migdal Hamea Clinic Active, not recruiting
Tel Aviv, Israel, 6203854
Italy
IRCCS Saverio De Bellis Recruiting
Castellana Grotte, Bari, Italy, 70013
AOU Sant'Orsola-Malpighi Recruiting
Bologna, BO, Italy, 40138
A.O.U. Policlinico G. Martino Recruiting
Messina, ME, Italy, 98125
Istituto Clinico Humanitas Active, not recruiting
Rozzano, Milan (MI), Italy, 20089
ASST Rhodense - Ospedale di Circolo di Rho Active, not 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 Recruiting
Udine, Italy, 33100
Korea, Republic of
Kyungpook National University Hospital Active, not recruiting
Daegu, Korea, Republic of, 41944
Keimyung University Dongsan Hospital Active, not recruiting
Daegu, Korea, Republic of, 42601
Severance Hospital, Yonsei University Health System Active, not recruiting
Seoul, Korea, Republic of, 03722
The Catholic University of Korea, Seoul St. Mary's Hospital Active, not recruiting
Seoul, Korea, Republic of, 06591
Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Wojewodzki Szpital Zespolony Recruiting
Bialystok, Poland, 15-950
ETG Kielce Active, not recruiting
Kielce, Poland, 25-355
Gastromed Sp. z o.o. Recruiting
Lublin, Poland, 20-582
Ai Centrum Medyczne Sp. Z O.O. Sp.K. Active, not 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 Recruiting
Warszawa, Poland, 00-635
WIP Warsaw IBD Point Profesor Kierkus Recruiting
Warszawa, Poland, 00-728
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 Active, not 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 Active, not recruiting
Bucuresti, Sector 1,, Romania, 010825
S.C. Cabinet Particular Policlinic Algomed SRL Active, not recruiting
Timisoara, Timis, Romania, 300002
Spitalul Clinic Colentina, Sectia de Gastroenterologie Active, not recruiting
Bucuresti, Romania, 020125
Russian Federation
Euromedclinic-24 Recruiting
Moscow, Russian Federation, 105264
LLC "Olla-Med" Recruiting
Moscow, Russian Federation, 105554
FSAEI HE I.M.Sechenov 1st Moscow State Medical University of the MoH of the RF (Sechenov University) Active, not recruiting
Moscow, Russian Federation, 119048
FSAEI HE I.M.Sechenov 1st Moscow State Medical University of the MoH of the RF (Sechenov University) Active, not recruiting
Moscow, Russian Federation, 119435
Limited Liability Company "Medicinsky Center SibNovoMed" Recruiting
Novosibirsk, Russian Federation, 630005
LLC Novosibirskiy Gastrocentr Recruiting
Novosibirsk, Russian Federation, 630007
Novosibirskiy Gastrocenter Recruiting
Novosibirsk, Russian Federation, 630007
Federal State Budgetary Scientific Institution Terminated
Novosibirsk, Russian Federation, 630117
FGBOU VO OmGMU Minzdrava Rossii Recruiting
Omsk, Russian Federation, 644050
FSBEI HE "Rostov State Medical University" of the Ministry of Healthcare of the Russian Federation Active, not recruiting
Rostov-on-Don, Russian Federation, 344022
State Budgetary Institution of Ryazan Region "Regional Clinical Hospital" Active, not 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 Active, not recruiting
Samara, Russian Federation, 443011
Private Healthcare Institution "Clinical Hospital "RZhD-Medicina" City Samara" Recruiting
Samara, Russian Federation, 443029
LLC Medical Company Hepatolog Recruiting
Samara, Russian Federation, 443063
LLC Medical Company Hepatolog Recruiting
Samara, Russian Federation, 443076
Clinics of Samara State Medical University Recruiting
Samara, Russian Federation, 443079
LLC Medical Company Hepatolog Recruiting
Samara, Russian Federation, 443093
State Budgetary Institution of Healthcare Yaroslavl Regional Clinical Hospital Active, not recruiting
Yaroslavl, Russian Federation, 150062
Serbia
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
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 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 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 Active, not 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 Active, not recruiting
Kocaeli, Turkey, 41380
Bulent Ecevit Universitesi Tip Fakultesi Recruiting
Kozlu Zonguldak, Turkey, 67600
Mersin Universitesi Tip Fakultesi Hastanesi Recruiting
Mersin, Turkey, 33110
Bulent Ecevit Universitesi Tip Fakultesi Recruiting
Zonguldak, Turkey, 67600
Ukraine
Regional Consultative Polyclinic Active, not recruiting
Chernivtsi, Ukraine, 58000
Regional Municipal Institution "Chernivtsi Regional Clinical Hospital", gastroenterology department, Active, not recruiting
Chernivtsi, Ukraine, 58001
Municipal Non-Commercial Enterprise Municipal Clinical Hospital 2 Name Shalimov Kharkiv City Council Active, not recruiting
Kharkiv, Ukraine, 61037
Municipal Institution "Kherson City Clinical Hospital n.a. Afanasiy and Olga Tropiny" Active, not recruiting
Kherson, Ukraine, 73000
Private Enterprise of Private Manufacturing Company "Acinus", Medical and Diagnostic Center Active, not recruiting
Kropyvnytskyi, Ukraine, 25006
Kyiv Municipal Clinical Hospital #18, Proctology Department Active, not 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 Active, not recruiting
Lviv, Ukraine, 79007
Municipal City Clinical Hospital of Emergency Active, not recruiting
Lviv, Ukraine, 79059
Municipal Institution "Odesa Regional Clinical Hospital" Active, not recruiting
Odesa, Ukraine, 65025
Municipal Institution of Ternopil regional council Ternopil University Hospital Active, not recruiting
Ternopil, Ukraine, 46002
Municipal Institution "Uzhgorod Regional Hospital" Active, not 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 Active, not 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    
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: September 3, 2020
Last Verified: September 2020
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