To answer the question of overall benefit: risk of celecoxib when compared to two most commonly prescribe traditional (non-selective) nonsteroidal anti-inflammatory drugs (NSAIDs) in the treatment of arthritis pain. For this purpose, patients with osteoarthritis or rheumatoid arthritis with or at risk of developing cardiovascular disease will be recruited. The cardiovascular, gastrointestinal and...
Date First Received: June 28, 2006
Last Updated: June 10, 2008
Verified by: Pfizer, June 2008
Clinical Trial Phase: Phase 4 | Start Date: October 2006
Overall Status: Recruiting
Estimated Enrollment: 20000
Brief Summary
Official Title: “A Randomized, Double Blind, Parallel-Group Study Of Cardiovascular Safety In Osteoarthritis Or Rheumatoid Arthritis Patients With Or At High Risk For Cardiovascular Disease Comparing Celecoxib With Naproxen And Ibuprofen”
Condition Keyword(s):
Intervention(s):
To answer the question of overall benefit: risk of celecoxib when compared to two most commonly prescribe traditional (non-selective) nonsteroidal anti-inflammatory drugs (NSAIDs) in the treatment of arthritis pain. For this purpose, patients with osteoarthritis or rheumatoid arthritis with or at risk of developing cardiovascular disease will be recruited.
The cardiovascular, gastrointestinal and renal safety and symptomatic benefit in each treatment group will be assessed accordingly.
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety Study
Outcome Measures for this Clinical Trial
Primary:
- The first occurrence of cardiovascular death (including hemorrhagic death), non-fatal myocardial infarction, or non-fatal stroke (APTC composite endpoint). up to 18 months Yes
Secondary:
- The first occurrence of a MACE defined as the composite of cardiovascular death (including hemorrhagic death), non-fatal MI, non-fatal stroke, hospitalization for UA, revascularization or hospitalization for TIA up to 18 months Yes
- The occurrence of Clinical Significant Gastrointestinal Events (CSGIEs) up to 18 months Yes
- Patient's Assessment of Arthritis Pain (VAS) up to 18 months Yes
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Subjects with osteoarthritis or rheumatoid Arthritis with or at risk of developing cardiovascular disease and who require and eligible for chronic, daily therapy with an NSAID to control arthritis sign and symptoms.
Exclusion Criteria:
- Subjects have had a recent cardiovascular event, unstable cardiovascular conditions, or any major surgery (cardiac or non-cardiac) within 3 months prior to randomization;
- Subjects with medical or laboratory abnormality that would make the subject inappropriate for entry into this trial
- Subjects require treatment with aspirin > 325 mg /day
- Subjects with known hypersensitivity to celecoxib, ibuprofen, naproxen, aspirin or esomeprazole, etc.
Clinical Trials Locations, Contact Details, and Sponsors
Lead Sponsor: Pfizer
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Huntsville Alabama 35801 United States
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Haleyville Alabama 35565 United States
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Alabaster Alabama 35007 United States
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Birmingham Alabama 35242 United States
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Montgomery Alabama 36111 United States
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Phoenix Arizona 85020 United States
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Tucson Arizona 85715 United States
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Glendale Arizona 85306 United States
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Fayetteville Arkansas 72703 United States
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San Diego California 92123 United States
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Stockton California 95204 United States
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Lewes Delaware 19958 United States
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Wilmington Delaware 19808 United States
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Washington District of Columbia 20006 United States
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Washington District of Columbia 20003 United States
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Destin Florida 32541 United States
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Miami Florida 33143 United States
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Ocala Florida 34474 United States
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Gainesville Florida 32605 United States
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Longwood Florida 32779 United States
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Jacksonville Florida 32216 United States
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Marianna Florida 32446 United States
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Miami Florida 33176 United States
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Jupiter Florida 33458-3030 United States
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Inverness Florida 34452 United States
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Fort Walton Beach Florida 32547 United States
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Sarasota Florida 34239 United States
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Daytona Beach Florida 32114 United States
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Miami Florida 33137 United States
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Largo Florida 33773 United States
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Merritt Island Florida 32953 United States
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Ocoee Florida 34761 United States
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Clearwater Florida 33765 United States
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Atlantis Florida 33462 United States
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GAINESVILLE Florida 32610 United States
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Orlando Florida 32803-1849 United States
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Palm Harbor Florida 34684 United States
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Aventura Florida 33180 United States
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Winter Park Florida 32790 United States
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Fort Myers Florida 33916 United States
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Clearwater Florida 33755 United States
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Crystal River Florida 34429 United States
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Madeira Beach Florida 33708 United States
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Fort Lauderdale Florida 33316 United States
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Clearwater Florida 33756 United States
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Lebanon Tennessee 37087 United States
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Columbia Tennessee 38401 United States
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Fayetteville Tennessee 37334 United States
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Plano Texas 75093 United States
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San Antonio Texas 78217 United States
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Dallas Texas 75235 United States
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Fort Worth Texas 76104 United States
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San Antonio Texas 78224 United States
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San Antonio Texas 78229 United States
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Garland Texas 75041 United States
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San Antonio Texas 78213 United States
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Dallas Texas 75231 United States
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Amarillo Texas 79106 United States
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San Antonio Texas 78230 United States
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Galveston Texas 77555 United States
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Arlington Texas 76017 United States
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Bedford Texas 76021 United States
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Houston Texas 77025-1669 United States
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Euless Texas 76039 United States
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Bellaire Texas 77401 United States
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Beaumont Texas 77702 United States
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Colleyville Texas 76034-3940 United States
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Lewisville Texas 75067 United States
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Mesquite Texas 75150 United States
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Friendswood Texas 77546 United States
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Fort Worth Texas 76117 United States
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McAllen Texas 78503 United States
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Arlington Texas 76013 United States
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Pasadena Texas 77504 United States
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Houston Texas 77008 United States
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Sugar Land Texas 77479 United States
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Grand Prairie Texas 75052 United States
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San Antonio Texas 78205 United States
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Houston Texas 77004 United States
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Dallas Texas 75226 United States
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Houston Texas 77043 United States
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Houston Texas 77024 United States
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Corpus Christi Texas 78411 United States
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Daville Virginia 24541 United States
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Roanoke Virginia 24014 United States
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Newport News Virginia 23601 United States
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Falls Church Virginia 22044 United States
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Chesapeake Virginia 23320-4985 United States
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Chesapeake Virginia 23320 United States
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Portsmouth Virginia 23701 United States
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Petersburg Virginia 23803 United States
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Norfolk Virginia 23502 United States
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Williamsburg Virginia 23185 United States
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Suffolk Virginia 23434 United States
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Viginia Beach Virginia 23455 United States
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Richmond Virginia 23225 United States
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Burke Virginia 22015 United States
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Seattle Washington 98166-2967 United States
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Wenatchee Washington 98801 United States
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Tacoma Washington 98405 United States
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Spokane Washington 99204 United States
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Yakima Washington 98902 United States
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Tacoma Washington 98405-2308 United States
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Tacoma Washington 98405 United States
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Spokane Washington 99218 United States
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Seattle Washington 98144 United States
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Spokane Washington 99216 United States
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Huntington West Virginia 25702 United States
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Beckley West Virginia 25801 United States
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Parkers West Virginia 26101 United States
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Lewisburg West Virginia 24901 United States
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Madison Wisconsin 53715 United States
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Wauwatosa Wisconsin 53226 United States
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Milwaukee Wisconsin 53215 United States
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Wausau Wisconsin 54401 United States
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Oak Creek Wisconsin 53154 United States
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Parramatta Park Queensland 4870 Australia
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MALVERN Victoria 3144 Australia
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Clayton Victoria 3168 Australia
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Shenton Park Western Australia 6008 Australia
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Victoria Park Western Australia 6979 Australia
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Goiânia GO 74043-110 Brazil
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Belo Horizonte Minas Gerais 30150-260 Brazil
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Rio de Janeiro RJ 22280-000 Brazil
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Rio de Janeiro RJ 21941-913 Brazil
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Rio de Janeiro RJ 22649-900 Brazil
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Porto Alegre RS 90035-903 Brazil
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Porto Alegre RS 90610-000 Brazil
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Campinas SP 13083-888 Brazil
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Sao Paulo SP 04230-000 Brazil
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Campinas SP 13060-904 Brazil
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Sao Paulo SP 04039-030 Brazil
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Campinas SP 13059-740 Brazil
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Quebec G1G 4A2 Canada
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Edmonton Alberta T6K 4C1 Canada
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Calgary Alberta T2X 3X7 Canada
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Edmonton Alberta T5K 2A2 Canada
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North Vancouver British Columbia V7N 4M2 Canada
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West Vancouver British Columbia V7V 4Y1 Canada
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Victoria British Columbia V8P 5P6 Canada
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West Vancouver British Columbia V7V 3S8 Canada
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Vancouver British Columbia V6H 3X8 Canada
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Vancouver British Columbia V6Z 2E8 Canada
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Winnipeg Manitoba R3A 1M3 Canada
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Winnipeg Manitoba R2V 4W3 Canada
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Winnipeg Manitoba R3C 1A2 Canada
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Rothesay New Brunswick E2E 6E4 Canada
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Moncton New Brunswick E1G 1A7 Canada
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Saint John New Brunswick E2K 2T8 Canada
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St. John's Newfoundland and Labrador A1A 3R5 Canada
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St. John's Newfoundland and Labrador A1E 2E2 Canada
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St. John's Newfoundland and Labrador A1C 2H5 Canada
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St. John's Newfoundland and Labrador A1B 3E1 Canada
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Mount Pearl Newfoundland and Labrador A1N 1W7 Canada
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St. John's Newfoundland and Labrador A1L 1C6 Canada
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St. John's Newfoundland and Labrador A1E 2C2 Canada
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Halifax Nova Scotia B3K 5R3 Canada
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Truro Nova Scotia B2N 1L2 Canada
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Corunna Ontario N0N 1G0 Canada
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Sarnia Ontario N7T 4X3 Canada
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London Ontario N6H 4P2 Canada
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Strathroy Ontario N7G 3E3 Canada
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Newmarket Ontario L3Y 5G8 Canada
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London Ontario N5W 6A2 Canada
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Kitchener Ontario N2M 5N6 Canada
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Toronto Ontario M8V 3X8 Canada
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London Ontario N5Y 5K7 Canada
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Toronto Ontario M9W 4L6 Canada
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Windsor Ontario N8X 5A6 Canada
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Toronto Ontario M3M 3E5 Canada
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Newmarket Ontario L3Y 3R7 Canada
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Niagara Falls Ontario L2E 7H1 Canada
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Mississauga Ontario L5M 2V8 Canada
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Hamilton Ontario L8N 1Y2 Canada
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Brampton Ontario L6T 3J1 Canada
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Toronto Ontario M6A 3B5 Canada
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London Ontario N5W 3C6 Canada
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Scarborough Ontario M1R 3A6 Canada
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Toronto Ontario M6H 3M2 Canada
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Brampton Ontario L6R 3A5 Canada
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Kitchener Ontario N2E 4H9 Canada
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Fort Erie Ontario L2A 1Z3 Canada
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Toronto Ontario M4S 1Y2 Canada
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Ottawa Ontario K1K 4K4 Canada
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Mississauga Ontario L4T 4J2 Canada
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Ottawa Ontario K1S 1C2 Canada
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London Ontario N6H 4P2 Canada
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London Ontario N6A 5R9 Canada
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L'Ancienne-Lorette Quebec G2E 2X1 Canada
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Cowansville Quebec J2K 2X9 Canada
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Westmount Quebec H3Z 2M6 Canada
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Chicoutimi Quebec G7H 5H6 Canada
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Saint-Marc-des-Carrières Quebec G0A 4B0 Canada
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Pointe-Claire Quebec H9R 4S3 Canada
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Montreal Quebec H1T 1C8 Canada
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Montreal Quebec H1L 6J5 Canada
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Rosemere Quebec J7A 1K7 Canada
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Trois-Rivières Quebec G8Z 1Y2 Canada
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St-Jerome Quebec J7Z 5T3 Canada
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Montreal Quebec H3N 1S4 Canada
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Levis Quebec G6V 4Z5 Canada
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Saskatoon Saskatchewan S7K OH6 Canada
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Medellin Antioquia Colombia
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Medellin Antioquia 0 Colombia
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Bogota Cundinamarca 0 Colombia
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Bogota Cundinamarca 0 Colombia
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Pasto Narino 0 Colombia
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Floridablanca Santander Colombia
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Cali Valle Colombia
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Alajuela Costa Rica
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Cartago Costa Rica
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Cartago 7050 Costa Rica
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Heredia Costa Rica
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San Jose Costa Rica
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San Jose Costa Rica
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Desamparados San Jose Costa Rica
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Escazu San Jose Costa Rica
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Guadalupe San José Costa Rica
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Pokfulam Hong Kong
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Shatin NT Hong Kong
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Sheung Shui, NT Hong Kong
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MEXICO D.F. 03300 Mexico
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Metepec Estado de Mexico 52140 Mexico
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Leon Guanajuato 37520 Mexico
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Guadalajara Jalisco 44690 Mexico
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Guadalajara Jalisco CP 44340 Mexico
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MORELIA MICHOACAN 58000 Mexico
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San Luis Potosi SLP 78240 Mexico
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Lima Lima 29 Peru
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Lima 11 Peru
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Lima L 27 Peru
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Lima L 33 Peru
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Lima L34 Peru
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Manila 1015 Philippines
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Quezon City 1102 Philippines
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Manila 1003 Philippines
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Dasmarinas Cavite 4114 Philippines
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Kaohsiung 807 Taiwan
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Taipei 112 Taiwan
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Taichung 407 Taiwan
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Taipei 100 Taiwan
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Taipei 100 Taiwan
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Dalin Town Chia-Yi County 622 Taiwan
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Nio Sung Township Kaohsiung County 833 Taiwan
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Kwei Shan Town Taoyuan County 333 Taiwan
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Tainan Yung Kang 710 Taiwan
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Zhytomyr 10003 Ukraine
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Ternopil 46003 Ukraine
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Kharkiv 61002 Ukraine
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Kharkiv 61178 Ukraine
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Kyiv 03680 Ukraine
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Kyiv 04053 Ukraine
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Lutsk 43024 Ukraine
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Zaporizhzhia 69118 Ukraine
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Kyiv 02091 Ukraine
Overall Clinical Trial Officials and Contacts
Pfizer CT.gov Call Center Study Director Pfizer
Overall Contact: Pfizer CT.gov Call Center 1-800-718-1021
Additional Information
Information obtained from ClinicalTrials.gov on July 18, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00346216
Study ID Number: A3191172
ClinicalTrials.gov Identifier: NCT00346216
Health Authority: United States: Food and Drug Administration
To obtain contact information for a study center near you, click here.
Clinical Trials Authorship and Review
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
