GI-Reasons- A Trial Of GI Safety Of Celecoxib Compared With Non-Selective Nonsteroidal Antiinflammatory Drugs (NSAIDS)
NCT ID: NCT00373685
Last Updated: 2021-03-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
8067 participants
INTERVENTIONAL
2006-10-31
2010-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Celecoxib
dosing as per USPI label
Celecoxib
open-label
NSAIDs
Any commercially available NSAID with the indication for osteoarthritis
dosing as per USPI label related to the chosen commercially marketed NSAID
Interventions
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Celecoxib
open-label
Any commercially available NSAID with the indication for osteoarthritis
dosing as per USPI label related to the chosen commercially marketed NSAID
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients with a history of myocardial infarction, unstable angina, ischemic or hemorrhagic stroke, transient ischemic attack, previous revascularization procedure to coronary, carotid, cerebral, renal, aortic or peripheral arterial vasculature.
55 Years
99 Years
ALL
No
Sponsors
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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Abbeville, Alabama, United States
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Alexander City, Alabama, United States
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Bay Minette, Alabama, United States
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Birmingham, Alabama, United States
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Birmingham, Alabama, United States
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Birmingham, Alabama, United States
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Birmingham, Alabama, United States
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Birmingham, Alabama, United States
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Birmingham, Alabama, United States
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Dothan, Alabama, United States
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Geneva, Alabama, United States
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Scottsdale, Arizona, United States
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Hot Springs, Arkansas, United States
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Little Rock, Arkansas, United States
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Anaheim, California, United States
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El Cajon, California, United States
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Sacramento, California, United States
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San Diego, California, United States
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Santa Maria, California, United States
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Melbourne, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami Beach, Florida, United States
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Niceville, Florida, United States
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North Miami, Florida, United States
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Orange City, Florida, United States
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Oviedo, Florida, United States
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Tallahassee, Florida, United States
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Wellington, Florida, United States
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Bainbridge, Georgia, United States
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Cairo, Georgia, United States
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Calhoun, Georgia, United States
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Columbus, Georgia, United States
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Covington, Georgia, United States
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Dawsonville, Georgia, United States
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Dunwoody, Georgia, United States
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Hampton, Georgia, United States
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Hinesville, Georgia, United States
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Roswell, Georgia, United States
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Savannah, Georgia, United States
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Honolulu, Hawaii, United States
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Flossmoor, Illinois, United States
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Greenville, Illinois, United States
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Hanna City, Illinois, United States
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Moline, Illinois, United States
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O'Fallon, Illinois, United States
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Fort Dodge, Iowa, United States
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Waterloo, Iowa, United States
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Arkansas City, Kansas, United States
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Kansas City, Kansas, United States
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Mission, Kansas, United States
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Newton, Kansas, United States
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Pratt, Kansas, United States
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Shawnee Mission, Kansas, United States
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Topeka, Kansas, United States
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Wellington, Kansas, United States
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Wichita, Kansas, United States
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Hartford, Kentucky, United States
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Lexington, Kentucky, United States
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Richmond, Kentucky, United States
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Whitehouse Station, New Jersey, United States
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West Jordan, Utah, United States
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Annandale, Virginia, United States
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Bluefield, Virginia, United States
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Chatham, Virginia, United States
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Chesapeake, Virginia, United States
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Danville, Virginia, United States
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Hampton, Virginia, United States
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Honaker, Virginia, United States
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Leesburg, Virginia, United States
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Norfolk, Virginia, United States
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Portsmouth, Virginia, United States
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Richmond, Virginia, United States
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Vienna, Virginia, United States
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Virginia Beach, Virginia, United States
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Bellevue, Washington, United States
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Pasco, Washington, United States
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Selah, Washington, United States
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Spokane, Washington, United States
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Spokane, Washington, United States
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Tacoma, Washington, United States
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Walla Walla, Washington, United States
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Burnsville, West Virginia, United States
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Lewisburg, West Virginia, United States
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Ronceverte, West Virginia, United States
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Aguas Buenas, PR, Puerto Rico
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Hato Rey, PR, Puerto Rico
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Juncas, PR, Puerto Rico
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Juncos, PR, Puerto Rico
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Levittown, PR, Puerto Rico
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Manatí, PR, Puerto Rico
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Rio Piedras, PR, Puerto Rico
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San Juan, PR, Puerto Rico
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San Juan, PR, Puerto Rico
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San Juan, PR, Puerto Rico
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San Juan, PR, Puerto Rico
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Santa Isabel, PR, Puerto Rico
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Santurce, PR, Puerto Rico
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Trujillo Alto, PR, Puerto Rico
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Loíza, , Puerto Rico
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Orocovis, , Puerto Rico
Countries
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References
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Cryer B, Li C, Simon LS, Singh G, Stillman MJ, Berger MF. GI-REASONS: a novel 6-month, prospective, randomized, open-label, blinded endpoint (PROBE) trial. Am J Gastroenterol. 2013 Mar;108(3):392-400. doi: 10.1038/ajg.2012.467. Epub 2013 Feb 12.
Related Links
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Other Identifiers
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A3191331
Identifier Type: -
Identifier Source: org_study_id
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