Long-Term Study Of CP-690,550 In Subjects With Ulcerative Colitis (OCTAVE)

This study is currently recruiting participants.
Verified April 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01470612
First received: October 21, 2011
Last updated: April 20, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Ulcerative Colitis
Drug: CP-690,550
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi-Center, Open-Label Study Of CP-690,550 In Subjects With Moderate To Severe Ulcerative Colitis

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Safety measured by the number of reported adverse events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The proportion of subjects in remission. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • The proportion of subjects in partial Mayo score remission. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • The proportion of subjects who achieve mucosal healing. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • The proportion of subjects with total score in Inflammatory Bowel Disease Questionnaire greater than or equal to 170. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Number of subjects with serious infections. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Number of subjects with adjudicated cardiovascular events. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Number of subjects with malignancies confirmed by central laboratory pathologist over read. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Proportion of subjects with addition of lipid lowering agents. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 725
Study Start Date: October 2012
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CP-690,550 5 mg BID
5 mg BID
Drug: CP-690,550
5 mg tablets, BID, for at least 12 months
Experimental: CP-690,550 10 mg BID
10 mg BID
Drug: CP-690,550
10 mg tablets, BID, for at least 12 months

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01470612

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

  Hide Study Locations
Locations
United States, Alabama
Horizon Research Group, Inc. Not yet recruiting
Mobile, Alabama, United States, 36608
Internal Medicine Center, LLC Not yet recruiting
Mobile, Alabama, United States, 36608
Springhill Memorial Hospital Not yet recruiting
Mobile, Alabama, United States, 36608
United States, Arizona
Desert Sun Gastroenterology Not yet recruiting
Tucson, Arizona, United States, 85710
Desert Sun Surgery Center Not yet recruiting
Tucson, Arizona, United States, 85710
Desert Sun Clinical Research Not yet recruiting
Tucson, Arizona, United States, 85710
United States, California
UCSD Division of Gastroenterology Recruiting
La Jolla, California, United States, 92093
West Gastroenterology Medical Group Not yet recruiting
Long Beach, California, United States, 90813
Cedars-Sinai Medical Center - Inflammatory Bowel Disease Center Recruiting
Los Angeles, California, United States, 90048
UCLA Not yet recruiting
Los Angeles, California, United States, 90095
Southern California Research Institute Medical Group, Inc - West Gastroenterology Medical Group Not yet recruiting
Los Angeles, California, United States, 90045
Cedars Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Alliance Clinical Research Not yet recruiting
Oceanside, California, United States, 92056
Homan A Zadeh, MD, MPH Not yet recruiting
Palm Springs, California, United States, 92262
Hope Square Surgical Center Not yet recruiting
Rancho Mirage, California, United States, 92270
Clinical Applications Laboratories, Inc. Not yet recruiting
San Diego, California, United States, 92103
Sharp Rees-Stealy Medical Group, Inc. Recruiting
San Diego, California, United States, 92101
Sharp Rees-Stealy Medical Group, Inc. Recruiting
San Diego, California, United States, 92123
Sharp Rees-Stealy Medical Group Recruiting
San Diego, California, United States, 92101
University of California San Francisco Recruiting
San Francisco, California, United States, 94115
UCLA MOB Not yet recruiting
Santa Monica, California, United States, 90404
United States, Connecticut
Bristol Hospital Not yet recruiting
Bristol, Connecticut, United States, 06010
Connecticut Clinical Research Foundation Not yet recruiting
Bristol, Connecticut, United States, 06010
Endoscopy Center of Connecticut, LLC Recruiting
Guilford, Connecticut, United States, 06437
Endoscopy Center of Connecticut, LLC Recruiting
Hamden, Connecticut, United States, 06518
Gastroenterology Center of Connecticut, LLC Recruiting
Hamden, Connecticut, United States, 06518
Medical Research Center of Connecticut, LLC Recruiting
Hamden, Connecticut, United States, 06518
Yale University School of Medicine, Dept Internal Medicine/Sect Digestive Diseases Recruiting
New Haven, Connecticut, United States, 06510
United States, Florida
Center for Advanced Gastroenterology Not yet recruiting
Maitland, Florida, United States, 32751
MNH Surgical Center Not yet recruiting
Maitland, Florida, United States, 32751
Gastroenterology Group of Naples Not yet recruiting
Naples, Florida, United States, 34102
North Florida Gastroenterology Research, LLC Not yet recruiting
Orange Park, Florida, United States, 32073
Orange Park Surgery Center Not yet recruiting
Orange Park, Florida, United States, 32073
Citrus Ambulatory Surgery Center Not yet recruiting
Orlando, Florida, United States, 32806
Internal Medicine Specialists Not yet recruiting
Orlando, Florida, United States, 32806
Advanced Medical Research Center Not yet recruiting
Port Orange, Florida, United States, 32127
Endoscopy Center Not yet recruiting
Port Orange, Florida, United States, 32127
Port Orange Urgent Care Not yet recruiting
Port Orange, Florida, United States, 32127
Advanced Gastroenterology Center Not yet recruiting
Port Orange, Florida, United States, 32127
West Wind'r Research & Development, LLC Not yet recruiting
Tampa, Florida, United States, 33607
Tampa Bay Endoscopy Center Not yet recruiting
Tampa, Florida, United States, 33603
Florida Medical Clinic, P.A. Recruiting
Zephyrhills, Florida, United States, 33542
United States, Georgia
Georgia Endoscopy Center Recruiting
Alpharetta, Georgia, United States, 30005
Atlanta Gastroenterology Associates, LLC. Not yet recruiting
Atlanta, Georgia, United States, 30342
Atlanta Gastroenterology Associates Not yet recruiting
Atlanta, Georgia, United States, 30342
GI Consultants Recruiting
Atlanta, Georgia, United States, 30342
Saint Joseph's Hospital of Atlanta Not yet recruiting
Atlanta, Georgia, United States, 30342
Atlanta Gastroenterology Associates LLC Not yet recruiting
Atlanta, Georgia, United States, 30342
Cardiovascular Specialist Not yet recruiting
Atlanta, Georgia, United States, 30342
Atlanta Center for Gastroenterology, P.C. Not yet recruiting
Decatur, Georgia, United States, 30033
Emory Healthcare Heart Center Recruiting
Johns Creek, Georgia, United States, 30097
Gastroenterology Associates of Central Georgia, LLC Recruiting
Macon, Georgia, United States, 31201
Atlanta Gastroenterology Associates Recruiting
Suwanee, Georgia, United States, 30024
United States, Illinois
Southwest Gastroenterology Not yet recruiting
Oak Lawn, Illinois, United States, 60453
United States, Kansas
Cotton-O'Neil Clinical Research Center, Digestive Health Recruiting
Topeka, Kansas, United States, 66606
United States, Maryland
Gastrointestinal Diagnostic Center Not yet recruiting
Baltimore, Maryland, United States, 21229
Digestive Disease Associates, PA Not yet recruiting
Baltimore, Maryland, United States, 21229
Metropolitan Gastroenterology Group, PC - Chevy Chase Clinical Research Not yet recruiting
Chevy Chase, Maryland, United States, 20815
Howard County GIDC Not yet recruiting
Columbia, Maryland, United States, 21044
United States, Michigan
University of Michigan Health Systems Recruiting
Ann Arbor, Michigan, United States, 48109-5000
Clinical Research Institute of Michigan, LLC Not yet recruiting
Chesterfield, Michigan, United States, 48047
Center for Digestive Health Recruiting
Troy, Michigan, United States, 48098
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
United States, Missouri
Surgery Center of Columbia Not yet recruiting
Columbia, Missouri, United States, 65201
Hannibal Regional Hospital Not yet recruiting
Hannibal, Missouri, United States, 63401
Audrian Medical Center Not yet recruiting
Mexico, Missouri, United States, 65265
Center for Digestive & Liver Disease, Inc. Not yet recruiting
Mexico, Missouri, United States, 65265
Center for Advanced Medicine Not yet recruiting
Saint Louis, Missouri, United States, 63110
Washington University School of Medicine Not yet recruiting
St. Louis, Missouri, United States, 63110
United States, New Jersey
AGA Clinical Research Associates, LLC Not yet recruiting
Egg Harbor Township, New Jersey, United States, 08234
South Jersey Gastroenterology Not yet recruiting
Marlton, New Jersey, United States, 08053
The Gastroenterology Group of South Jersey Recruiting
Vineland, New Jersey, United States, 08360
United States, New York
NYU Langone Long Island Clinical Research Associates Recruiting
Great Neck, New York, United States, 11021
Nassau Gastroenterology Associates, PC Recruiting
Great Neck, New York, United States, 11021
NYU Langone Nassau Gastroenterology Associates Recruiting
Great Neck, New York, United States, 11021
Long Island Clinical Research Associates, LLP Recruiting
Great Neck, New York, United States, 11021
Department of Medicine, Clinical Trials Office Recruiting
New York, New York, United States, 10029
Mount Sinai School of Medicine Recruiting
New York, New York, United States, 10029
Present, Chapman, Steinlauf and Marion Recruiting
New York, New York, United States, 10028
Asher Kornbluth, MD PC Recruiting
New York, New York, United States, 10128
University of Rochester Not yet recruiting
Rochester, New York, United States, 14642
United States, North Carolina
LeBauer Endoscopy Center Not yet recruiting
Greensboro, North Carolina, United States, 27403
LeBauer HealthCare Not yet recruiting
Greensboro, North Carolina, United States, 27403
LeBauer Research Associates, PA Not yet recruiting
Greensboro, North Carolina, United States, 27403
Carolina Research - Carolina Digestive Diseases Recruiting
Greenville, North Carolina, United States, 27834
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Great Lakes Gastroenterology Recruiting
Mentor, Ohio, United States, 44060
United States, Pennsylvania
Donald Guthrie Foundation for Education and Research Not yet recruiting
Sayre, Pennsylvania, United States, 18840
United States, Tennessee
Vanderbilt University Medical Center - IDB Clinic Not yet recruiting
Nashville, Tennessee, United States, 37212
Vanderbilt University Medical Center -- Laboratory (Chest X-ray) Not yet recruiting
Nashville, Tennessee, United States, 37232
Vanderbilt University Medical Center - GCRC Not yet recruiting
Nashville, Tennessee, United States, 37232
Vanderbilt University Medical Center - GI Research Office Not yet recruiting
Nashville, Tennessee, United States, 37212
Vanderbilt University Medical Center - Heart Station Not yet recruiting
Nashville, Tennessee, United States, 37232
Vanderbilt University Medical Center - Drug Shipment Not yet recruiting
Nashville, Tennessee, United States, 37232-7610
United States, Texas
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
University Of Texas Health Science Center School Of Medicine Recruiting
Houston, Texas, United States, 77030
Baylor Medical Center Recruiting
Houston, Texas, United States, 77030
Gastroenterology Consultants, P.A. Not yet recruiting
Houston, Texas, United States, 77034
The University of Texas Houston Health Science Center Recruiting
Houston, Texas, United States, 77030
Houston Hospital for Specialized Surgery Recruiting
Houston, Texas, United States, 77004
Pasadena Gastroenterology Associates, P.A. dba Digestive Health Center Not yet recruiting
Pasadena, Texas, United States, 77505
Digestive Health Specialists of Tyler Recruiting
Tyler, Texas, United States, 75701
United States, Utah
Wasatch Endoscopy Center Recruiting
Salt Lake City, Utah, United States, 84124
Wasatch Clinical Research Recruiting
Salt Lake City, Utah, United States, 84107
Alpine Medical Group Recruiting
Salt Lake City, Utah, United States, 84102
United States, Virginia
Virginia Commonwealth University Health System Endoscopy Suite Not yet recruiting
Richmond, Virginia, United States, 23298
Virginia Commonwealth University Health System Digestive Health Center Not yet recruiting
Richmond, Virginia, United States, 23298
Virginia Commonwealth University Not yet recruiting
Richmond, Virginia, United States, 23298
United States, Wisconsin
Wisconsin Center for Advanced Research - GI Associates, LLC Recruiting
Milwaukee, Wisconsin, United States, 53215
Center for Digestive Health Recruiting
Milwaukee, Wisconsin, United States, 53215
Australia, Australian Capital Territory
The Canberra Hospital/Gastroenterology & Hepatology Unit, Level 2, Building 1 Not yet recruiting
Garron, Australian Capital Territory, Australia, 2605
Australia, New South Wales
Royal Prince Alfred Hospital Recruiting
Camperdown, New South Wales, Australia, 2050
Concord Repatriation General Hospital Not yet recruiting
Concord, New South Wales, Australia, 2139
Liverpool Hospital Eastern Campus Recruiting
Liverpool, New South Wales, Australia, 2170
Liverpool Hospital Pharmacy Recruiting
Liverpool, New South Wales, Australia, 2170
Australia, South Australia
Royal Adelaide Hospital Not yet recruiting
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Eastern Health, Box Hill Hospital Recruiting
Box Hill, Victoria, Australia, 3128
Monash Medical Centre Not yet recruiting
Clayton, Victoria, Australia, 3168
Australia
SA Pathology Not yet recruiting
Adelaide, Australia, 5000
Austria
Medizinische Universität Innsbruck Recruiting
Innsbruck, Austria, A-6020
AKH Wien Universitaetsklinik fuer Innere Medizin III Recruiting
Wien, Austria, 1090
Belgium
GZA St. Vincentius Recruiting
Antwerpen, Belgium, 2018
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg Recruiting
Leuven, Belgium, 3000
UZ Leuven Recruiting
Leuven, Belgium, 3000
Canada, Alberta
University of Calgary, Heritage Medical Research Clinic, TRW Building Recruiting
Calgary, Alberta, Canada, T2N 4Z6
University of Alberta Hospital - Walter C. Mackenzie Health Sciences Centre Not yet recruiting
Edmonton, Alberta, Canada, T6G 2B7
Zeidler Ledcor Centre, University Of Alberta Not yet recruiting
Edmonton, Alberta, Canada, T6G 2X8
University of Alberta - Zeidler Ledcor Centre Not yet recruiting
Edmonton, Alberta, Canada, T6G 2X8
Canada, Ontario
Hamilton Health Sciences Corporation Not yet recruiting
Hamilton, Ontario, Canada, L8N 3Z5
Robarts Clinical Trials - Robarts Research Institute Not yet recruiting
London, Ontario, Canada, N6A 5K8
London Health Sciences Centre - University Hospital Recruiting
London, Ontario, Canada, N6A 5A5
Canada, Quebec
Maisonneuve-Rosemont Hospital/Pavillon Rachel-Tourigny Not yet recruiting
Montreal, Quebec, Canada, H1T 2M4
McGill University Health Centre - Royal Victoria Hospital Recruiting
Montreal, Quebec, Canada, H3A 1A1
Canada, Saskatchewan
Saskatoon City Hospital Recruiting
Saskatoon, Saskatchewan, Canada, S7K 0M7
Royal University Hospital Recruiting
Saskatoon, Saskatchewan, Canada, S7N 0W8
Colombia
Centro Integral de Reumatologia REUMALAB S.A.S. Not yet recruiting
Medellin, Antioquia, Colombia
Instituto de Coloproctología ICO S.A.S. Not yet recruiting
Medellin, Antioquia, Colombia, 00000
Hospital Pablo Tobon Uribe Not yet recruiting
Medellin, Antioquia, Colombia, 00000
Czech Republic
Hepato-Gastroenterologie HK, s.r.o. Recruiting
Hradec Kralove, Czech Republic, 500 12
Institut klinicke a experimentalni mediciny Not yet recruiting
Praha 4, Czech Republic, 140 21
Synlab Czech S.R.O. Not yet recruiting
Praha 6 - Stresovice, Czech Republic, 169 00
Klinicke Centrum ISCARE I.V.F. Not yet recruiting
Praha 7, Czech Republic, 170 04
Poliklinika Prosek, Pneumologie Not yet recruiting
Praha 9 - Prosek, Czech Republic, 190 00
Nemocnice Strakonice, a.s., Interni oddeleni Recruiting
Strakonice, Czech Republic, 386 29
Krajska zdravotni, a.s. Masarykova nemocnice v Usti nad Labem Recruiting
Usti nad Labem, Czech Republic, 40113
Denmark
Aalborg Hospital/Department of Gastroenterology Aalborg Hospital Recruiting
Aalborg, Denmark, 9000
Aarhus University Hospital Department of Hepato Gastroenterrology V Aarhus Recruiting
Aarhus C, Denmark, 8000
Bispebjerg Hospital Not yet recruiting
Copenhagen NV, Denmark, DK2400
Odense University Hospital Department of Medical Gastroenterology S Odense University Hospital Recruiting
Odense, Denmark, 5000
Estonia
Ida-Viru Central Hospital Not yet recruiting
Kohtla-Jarve, Estonia, 30322
X-Ray Unit of East Viru Central Hospital Not yet recruiting
Kothla Jarve, Estonia, 30322
ECG Unit of East Viru Central Hospital Not yet recruiting
Kothla Järve, Estonia, 30322
ECG Unit, Innomedica MCRC Recruiting
Tallinn, Estonia, 10117
ECG Unit East Tallinn Central Hospital Not yet recruiting
Tallinn, Estonia, 10138
ECG Unit of West Tallinn Central Hospital Recruiting
Tallinn, Estonia, 10617
X-Ray Unit, East Tallinn Central Hospital Not yet recruiting
Tallinn, Estonia, 10138
X-Ray Department of West Tallinn Central Hospital Recruiting
Tallinn, Estonia, 10617
X-Ray department, Daugavpils Regional Hospital Recruiting
Tallinn, Estonia, 10117
Tartu University Hospital Division of Endocrinology and Gastroenterology Not yet recruiting
Tartu, Estonia, 51014
France
Hopital Saint-Louis Not yet recruiting
Paris Cedex 10, ILF, France, 75010
Hopital Beaujon Recruiting
Clichy Cedex, France, 92110
Hopital Saint Louis - Service d'hepato-gastroenterologie Not yet recruiting
Paris, France, 75010
Hopital Rangueil Recruiting
Toulouse Cedex 9, France, 31059
Germany
Klinikum Luneburg Not yet recruiting
Bogelstrafße 1, Luneburg, Germany, 21339
Universitaetsklinikum Schleswig-Holstein, Campus Kiel Recruiting
Kiel, Schleswig-Holstein, Germany, 24105
Charite, Universitaetsmedizin Berlin, Campus Virchow-Klinikum Recruiting
Berlin, Germany, 13353
Klinikum der Johann Wolfgang Goethe-Universitaet Not yet recruiting
Frankfurt, Germany, 60590
Universitätsklinikum Halle, Universitaetsklinik und Poliklinik fuer Innere Medizin I Not yet recruiting
Halle, Germany, 06120
Medizinishce Hochschule hannover Recruiting
Hannover, Germany, 30625
Universitatsklinikum Scheleswig-Holstein Recruiting
Kiel, Germany, 24105
Klinikum Lüneburg/Abteilung Gastroenterologie Not yet recruiting
Lüneburg, Germany, 21339
Gastroenterologische Gemeinschaftspraxis Minden Recruiting
Minden, Germany, 32423
University Hospital Munich-Grosshadern Not yet recruiting
Munich, Germany, 81377
Universitatsklinikum Ulm Recruiting
Ulm, Germany, 89081
Universitaetsklinikum Ulm Recruiting
Ulm, Germany, 89081
Hungary
Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház Not yet recruiting
Miskolc, Hungary, Europe, Hungary, H-3526
Dr. Rethy Pal Korhaz-Rendelointezet/III. Belgyogyaszat Not yet recruiting
Bekescsaba, Hungary, 5600
Pannonia Maganorvosi Centrum Kft. Not yet recruiting
Budapest, Hungary, H-1136
Szent Margit Kórház, III. Belgyógyászati-Gasztroenterológiai Osztály Not yet recruiting
Budapest, Hungary, H-1032
Peterfy Sandor utcai Korhaz Recruiting
Budapest, Hungary, H-1076
Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak I Belgyogyaszat Gasztroenterologia Osztaly Recruiting
Budapest, Hungary, H-1125
Szent Pantaleon Korhaz- Rendelointezet, Belgyogyaszat- Gasztroenterologiai Osztaly Not yet recruiting
Dunaujvaros, Hungary, 2400
Bekes Megyei Pandy Kalman Korhaz, III Gasztroenterologiai Osztaly Not yet recruiting
Gyula, Hungary, 5700
Somogy Megyei Kaposi Mor Oktato Korhaz Not yet recruiting
Kaposvar, Hungary, H-7400
Karolina Korhaz Rendelointezet ,Belgyogyaszat Not yet recruiting
Mosonmagyarovar, Hungary, H-9200
Pecsi Tudomanyegyetem Klinikai Kozpont Recruiting
Pecs, Hungary, H-7624
Szegedi Tudomanyegyetem Szent- Gyorgyi Albert Klinilai Kozpont Recruiting
Szeged, Hungary, 6720
Javorszky Odon Korhaz Not yet recruiting
Vac, Hungary, H2600
Israel
Kaplan Medical Center Not yet recruiting
Rehovot, Israel, 76100
Italy
Istituto Clinico Humanitas IRCCS - IBD Center Recruiting
Milan, Italy, 20089
Japan
Aichi Medical University Hospital Not yet recruiting
Nagakute, Aichi, Japan
National Hospital Organization Hirosaki National Hospital Recruiting
Hirosaki, Aomori, Japan
Hokkaido P.W.F.A.C Sapporo-Kosei general Hospital Recruiting
Sapporo, Hokkaido, Japan
The Hospital of Hyogo College of Medicine Recruiting
Nishinomiya, Hyogo, Japan
National Hospital Organization Mito Medical Center Not yet recruiting
Higashi Ibaraki Gun Ibarakimachi, Ibaraki, Japan
Susakikuroshio Hospital Not yet recruiting
Susaki, Kouchi, Japan
National Hospital Organization Sendai Medical Center Gastroenterology Recruiting
Sendai, Miyagi, Japan
Ikime Large Intestine Anus Surgery Internal Medicine Not yet recruiting
Miyazaki-shi, Miyazaki, Japan
Shiga University of Medical Science Hospital Not yet recruiting
Otsu, Shiga, Japan
Keio University Hospital Not yet recruiting
Shinjuku-ku, Tokyo, Japan
Social Insurance Chuo General Hospital Not yet recruiting
Shinjuku-ku, Tokyo, Japan
Toho University Sakura Medical Center Not yet recruiting
Chiba, Japan
Chiba University Hospital Recruiting
Chiba, Japan
Fukuoka University Chikushi Hospital Recruiting
Fukuoka, Japan
Kurume University Hospital Not yet recruiting
Fukuoka, Japan
Hiroshima University Hospital Recruiting
Hiroshima, Japan
Sameshima Hospital Recruiting
Kagoshima, Japan
Kuniyoshi Hospital Not yet recruiting
Kochi, Japan
Osaka Medical College Hospital Recruiting
Osaka, Japan
Osaka City University Hospital Recruiting
Osaka, Japan
Showa University Hospital Not yet recruiting
Tokyo, Japan
Tokai University Hachioji Hospital Recruiting
Tokyo, Japan
Kitasato University Kitasato Institute Hospital Recruiting
Tokyo, Japan
Tokyo Medical And Dental University Hospital, Faculty of Medicine Recruiting
Tokyo, Japan
"NTT Medical Center Tokyo, Clinical Control Office Not yet recruiting
Tokyo, Japan
Jikei University Hospital Recruiting
Tokyo, Japan
Korea, Republic of
Pusan National University Hospital, Clinical Laboratory Not yet recruiting
Seo-Gu, Busan, Korea, Republic of, 602-739
Pusan National University Hospital Not yet recruiting
Seo-Gu, Busan, Korea, Republic of, 602-739
Hanyang University Guri Hospital, Clinical Laboratory Recruiting
Guri-si, Gyeonggi-do, Korea, Republic of, 471-701
CHA Bundang Medical Center, CHA University Not yet recruiting
Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-712
CHA Bundang Medical Center, CHA University, Clinical Laboratory Not yet recruiting
Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-712
Kyung Hee University Hospital, Clinical Laboratory Recruiting
Dongdaemun-gu, Seoul, Korea, Republic of, 130-872
Hanyang Univ. Guri Hospital Recruiting
Gyunggi-do, Korea, Republic of, 471-701
Severance Hospital, Yonsei University Health System, Clinical Laboratory Not yet recruiting
Seoul, Korea, Republic of, 120-752
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 138-736
Seoul National University Hospital, Recruiting
Seoul, Korea, Republic of, 110-744
Severance Hospital, Yonsei University Health System Not yet recruiting
Seoul, Korea, Republic of, 120-752
Kyung Hee University Hospital / Department of Gastroenterology Recruiting
Seoul, Korea, Republic of, 130-872
Seoul National University Hospital, Clinical Laboratory Recruiting
Seoul, Korea, Republic of, 110-774
Samsung Medical Center, Division of Gastroenterology Not yet recruiting
Seoul, Korea, Republic of, 135-710
Latvia
Endoscopy Department, Daugavpils Regional Hospital Not yet recruiting
Daugavpils, Latvia, LV-5417
X-Ray department, Daugavpils Regional Hospital Not yet recruiting
Daugavpils, Latvia, LV-5417
X-Ray Department, P.Stradins Clinical University Hospital Not yet recruiting
Riga, Latvia, LV-1002
ECG Unit, P.Stradins Clinical University Hospital Not yet recruiting
Riga, Latvia, LV-1002
Digestive Diseases Center GASTRO Not yet recruiting
Riga, Latvia, LV-1006
Netherlands
VU Medisch Centrum/Department of Gastroenterology Recruiting
Amsterdam, Netherlands, 1081 HV
Academic Medical Center/inflammatory Bowel Disease Center/Department of Gastroenterology Recruiting
Amsterdam, Netherlands, 1105 AZ
University Medical Center Groningen, Hospital and Clinical Pharmacy Not yet recruiting
Groningen, Netherlands, 9713 AP
University Medical Center Groningen (UMCG) Not yet recruiting
Groningen, Netherlands, 9713 GZ
Leiden University Medical Center/Department of Gastroenterology Not yet recruiting
Leiden, Netherlands, 2333 ZA
New Zealand
Diagnostic Medlab Ltd Recruiting
Ellerslie, Auckland, New Zealand, 1060
Auckland City Hospital, LabPLUS Recruiting
Grafton, Auckland, New Zealand, 1010
Shakespeare Specialist Group Recruiting
Milford, Auckland, New Zealand, 0620
Auckland District Health Board, Auckland City Hospital Recruiting
Auckland, New Zealand, 1023
Christchurch Hospital DR RICHARD GEARRY Recruiting
Christchurch, New Zealand, 8011
Canterbury Health Laboratories Recruiting
Christchurch, New Zealand, 8011
Southern District Health Board Recruiting
Dunedin, New Zealand
Waikato District Health Board , Dr Melissa L Haines Not yet recruiting
Hamilton, New Zealand
Waikato Hospital Not yet recruiting
Hamilton, New Zealand, 32740
Clinical Trials Unit, BOP Clinical School, Bay of Plenty District Health Board Recruiting
Tauranga, New Zealand, 3143
PathLab BOP Recruiting
Tauranga, New Zealand, 3112
Pacific Radiology (X-rays only) Recruiting
Wellington, New Zealand, 6021
Aotea Pathology (Local Lab) Recruiting
Wellington, New Zealand, 6011
Bowen Hospital Recruiting
Wellington, New Zealand, 6035
P3 Research Limited Recruiting
Wellington, New Zealand, 6021
Poland
H-T. Centrum Medyczne - ENDOTERAPIA Not yet recruiting
Tychy, Slaskie, Poland, 43-100
Oddzial Chorob Wewnetrznych i Gastroenterologii, Not yet recruiting
Bialystok, Poland, 15-950
Centrum Endoskopii Zabiegowej, Poradnia Chorob Jelitowych Not yet recruiting
Bydgoszcz, Poland, 85-168
10 Wojskowy Szpital Kliniczny z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej Not yet recruiting
Bydgoszcz, Poland, 85-681
Gabinet Lekarski-Janusz Rudzinski Not yet recruiting
Bydgoszcz, Poland, 85-681
Gabinet Endoskopii Przewodu Pokarmowego Recruiting
Krakow, Poland, 31-009
Centrum Medyczne Szpital Swietej Rodziny/Research and Development Department Recruiting
Lodz, Poland, 90-302
Uniwersytecki Szpital Kliniczny nr 1 im. N. Barlickiego, Zaklad Radiologii Not yet recruiting
Lodz, Poland, 90-153
Centrum Medyczne - Szpital Swietej Rodziny Sp. z o.o. Recruiting
Lodz, Poland, 90-302
Uniwersytecki Szpital Kliniczny nr 1 im. N. Barlickiego, Not yet recruiting
Lodz, Poland, 90-153
SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi Not yet recruiting
Lodz, Poland, 90-153
Endoskopia SP. Z O.O. Recruiting
Sopot, Poland, 81-756
Zaklad Diagnostyki Radiologicznej, Centralny Szpital Kliniczny MSWiA Recruiting
Warszawa, Poland, 02-507
Nzoz Vivamed Recruiting
Warszawa, Poland, 03-580
Centrum Badawcze Wspolczesnej Terapii Not yet recruiting
Warszawa, Poland, 02-679
Klinika Chorob Wewnetrznych i Gastroenterologii z Pododdzialem Leczenia Recruiting
Warszawa, Poland, 02-507
Romania
Spitalul Clinic Judetean Mures, Sectia Clinica de Gastroenterologie Not yet recruiting
Targu Mures, Mures, Romania, 540103
Spital Clinic Dr. I. Cantacuzino Bucuresti Not yet recruiting
Bucharest, Sector 2, Romania, 020475
Policlinica Dr. Citu/Internal medicine, gastroenterology Not yet recruiting
Timisoara, Timis, Romania, 300593
Spitalul Universitar de Urgenta Recruiting
Bucharest, Romania, 050098
Endocenter Medicina Integrativa Not yet recruiting
Bucuresti, Romania, 021978
Emergency Universitary County Hospital Tg. Mures Not yet recruiting
Targu Mures, Romania, 540136
Cabinet Particular Policlinic Algomed Srl Recruiting
Timisoara, Romania, 300002
Russian Federation
Municipal budget Institute of Healthcare "Central City Hospital of Pyatigorsk" Not yet recruiting
Pyatigorsk, Stavropol region russia, Russian Federation, 357500
Federal state budget institution "State scientific centre of coloproctology" Not yet recruiting
Moscow, Russian Federation, 123423
State budget Healthcare Institution Moscow regional scientific research clinical institute Not yet recruiting
Moscow, Russian Federation, 129110
State Institution of Healthcare Nizhniy Novgorod Regional Clinical Hosp named after N.A. Semashko Not yet recruiting
Nizhniy Novgorod, Russian Federation, 603126
City Clinical Hospital #12 Not yet recruiting
Novosibirsk, Russian Federation, 630084
Novosibirsk State Medical University Not yet recruiting
Novosibirsk, Russian Federation, 630091
Municipal institution of healthcare "City clinical hospital 12" Not yet recruiting
Saratov, Russian Federation, 410039
Clinical Hospital #2 Not yet recruiting
Yaroslavl, Russian Federation, 150010
OOO Medical Center of Diagnostics and Prophylaxis "Sodruzhestvo" Not yet recruiting
Yaroslavl, Russian Federation, 150040
State budget institution of healthcare of Yaroslavl region Regional clinical hospital Not yet recruiting
Yaroslavl, Russian Federation, 150062
Yaroslavl State Medical Academy Not yet recruiting
Yaroslavl, Russian Federation, 150000
Slovakia
Nzz - Gastroenterologicka Ambulancia Not yet recruiting
Bratislava, Slovakia, 833 05
Gastroenterological Centre Thalion Not yet recruiting
Bratislava, Slovakia, 831 04
Univerzitna nemocnica Bratislava/ I. Interna klinika, Endoskopicke pracovisko Not yet recruiting
Bratislava, Slovakia, 813 69
Prevencia a zdravie s.r.o. Not yet recruiting
Bratislava, Slovakia, 85101
Lekaren Amarth Not yet recruiting
Bratislava, Slovakia, 831 04
Nestatna Gastroenterologicka ambulancia Not yet recruiting
Bratislava, Slovakia, 851 01
ProCare Medicinske centrum Nitra/Gastroenterologicka Ambulancia Not yet recruiting
Nitra, Slovakia, 949 01
Fakultna nemocnica Nitra, Ustav klinickej mikrobiologie Not yet recruiting
Nitra, Slovakia, 949 01
Fakultna nemocnica Nitra, Ustav klinickej mikrobiologie Not yet recruiting
Nitra, Slovakia, 950 01
Jessenius - diagnosticke centrum a.s. Recruiting
Nitra, Slovakia, 949 01
Kardiocentrum Nitra s.r.o. Recruiting
Nitra, Slovakia, 949 01
KM Management spol. s.r.o. Recruiting
Nitra, Slovakia, 949 01
South Africa
Chris Hani Baragwanath Academic Hospital Not yet recruiting
Johannesburg, Gauteng, South Africa, 2013
Panorama MediClinic Recruiting
Cape Town, Western Cape, South Africa, 7500
The Loius Leipoldt Medical Centre Not yet recruiting
Cape Town, Western Cape, South Africa, 7530
Dr JP Wright Recruiting
Cape Town, Western Cape, South Africa, 7708
Endocare Research Centre Not yet recruiting
Cape Town, Western Cape, South Africa, 7646
Spain
Hospital Universitario de Fuenlabrada Not yet recruiting
Fuenlabrada, Madrid, Spain, 28942
Corporacio Sanitaria Parc Tauli Not yet recruiting
Barcelona, Spain, 08208
Hospital Universitari de Bellvitge Not yet recruiting
Barcelona, Spain, 08907
Hospital Clinic i Provincial de Barcelona Servicio de Ap. Digestivo Recruiting
Barcelona, Spain, 08036
Hospital Universitario de La Princesa Not yet recruiting
Madrid, Spain, 28006
Hospital Clinico San Carlos Not yet recruiting
Madrid, Spain, 28040
Hospital Universitario de Fuenlabrada Not yet recruiting
Madrid, Spain, 28942
Taiwan
Biomedical Systems Not yet recruiting
Belgium, Taiwan
Robart Clinical Trial Not yet recruiting
Canada, Taiwan
Quintiles East Asia Pte Ltd Not yet recruiting
Singapore, Taiwan, 118264
National Taiwan University Hospital, Department of Laboratory Medicine Not yet recruiting
Taipei, Taiwan, 100
National Taiwan University Hospital Not yet recruiting
Taipei City, Taiwan, 10002
Ukraine
I.M.C. of Crimean Republic Institution "Clinical Territorial Medical Community "University Clinic" Not yet recruiting
Simferopol, AR Krym, Ukraine, 95017
InternalMedicineCenterofCrimean RepublicInstitution"ClinicalTerritorialMedicalCommunity" Not yet recruiting
Simferopol, AR Krym, Ukraine, 95017
State Institution "S.I. Georgievsky Crimean State Medical University"/Department of Gastroenterology Not yet recruiting
Simferopol, AR Krym, Ukraine, 95017
Regional Municipal Institution- Chernivtsi Regional Clinical Hospital Not yet recruiting
Chernivtsi, Ukraine, 58001
State Institution "L.T. Malaya Therapy Institute of National Academy of Medical Sciences of Ukraine Not yet recruiting
Kharkiv, Ukraine, 61039
Municipal Healthcare Institution "Kharkiv City Clinical Hospital #2" Not yet recruiting
Kharkiv, Ukraine, 61037
State Institution "L.T. Malaya Therapy Institute of National Academy of Medical Sciences of Ukraine" Not yet recruiting
Kharkiv, Ukraine, 61039
Kyiv Municipal Clinical Hospital #18, Proctology Department Recruiting
Kyiv, Ukraine, 01030
Municipal City Clinical Hospital of the Emergency Medical Care 1 St Therapy Department of Hospital Recruiting
Lviv, Ukraine, 79059
State Institution District Clinical Hospital of Uzhgorod station Recruiting
Uzhgorod, Ukraine, 88009
"Health Clinic LLC" based on of Medical Diagnostic Center "Slaomed" "Slaomed" LLC" Not yet recruiting
Vinnytsia, Ukraine, 21029
Vinnytsia Regional Clinical Hospital for Invalids of the Great Patriotic War Not yet recruiting
Vinnytsia, Ukraine, 21005
M.I. Pyrogov Vinnytsya National Medical University Not yet recruiting
Vinnytsya, Ukraine, 21005
Minicipal Institution City Hospital #7 Recruiting
Zaporizhzhia, Ukraine, 69118
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01470612     History of Changes
Other Study ID Numbers: A3921139
Study First Received: October 21, 2011
Last Updated: April 20, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Ulcerative colitis
open-label
long term treatment

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 22, 2014