AzTrials
AzTrials

Arthritis, RheumatoidPhase 4PRECISIONNCT00346216

Prospective Randomized Evaluation Of Celecoxib Integrated Safety Vs Ibuprofen Or Naproxen

A Phase 4 study testing celecoxib, Ibuprofen and Naproxen in people with Arthritis, Rheumatoid, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 1,066 sites in 13 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Arthritis, Rheumatoid
What is being tested?
celecoxib, Ibuprofen and Naproxen
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24,081 participants
Where
1,066 sitesin 13 countries
Study dates
4 Oct 2006to 12 Apr 2016
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1,066 sites in 13 countries.

495 sites in 13 countries

United States300 sites

  • Odyssey Research/Sanford Clinic - Aberdeen

    Aberdeen, South Dakota, 57401

  • Sanford Clinic - Aberdeen

    Aberdeen, South Dakota, 57401

  • Daystar Clinical Research

    Akron, Ohio, 44313

  • Carol M. Johnson MD, LLC

    Alabaster, Alabama, 35007

  • Alliance Medical Center

    Alliance, Nebraska, 69301

  • Cody Medical Associates

    Alliance, Nebraska, 69301

  • University Orthopedics Center

    Altoona, Pennsylvania, 16602

  • Amarillo Medical Specialists, LLP

    Amarillo, Texas, 79106

  • Pharma Tex Research, LLC

    Amarillo, Texas, 79106

  • Anaheim Family Medical Center

    Anaheim, California, 92804

  • Advanced Research Center

    Anaheim, California, 92805

  • Community Clinical Research Center

    Anderson, Indiana, 46011

  • Anderson Heart

    Anderson, South Carolina, 29621

  • AnMed Health

    Anderson, South Carolina, 29621

  • Heartland Research Associates LLC

    Arkansas City, Kansas, 67005

  • Family Health Care Association

    Arlington, Texas, 76013

  • South Arlington Primary Care Associates PA

    Arlington, Texas, 76017

  • DCT - Anchor, LLC dba Discovery Clinical Trials

    Arlington, Texas, 76018

  • Advanced Arthritis & Rheumatology Center

    Artesia, California, 90701

  • Darrell E. Gorman, MD

    Arvada, Colorado, 80005

  • Asheville Arthritis & Osteoporosis, PA

    Asheville, North Carolina, 28803

  • Howard L. Feinberg, D.O.

    Ashland, Kentucky, 41101

  • Integrated Medical Research, PC

    Ashland, Oregon, 97520

  • The Kaufmann Clinic

    Atlanta, Georgia, 30308

  • Piedmont Heart Institute

    Atlanta, Georgia, 30309

  • Arthritis and Rheumatology of Georgia

    Atlanta, Georgia, 30342

  • Atlanta Center for Clinical Research, Corp.

    Atlanta, Georgia, 30342

  • Atlanta Vascular Research Foundation

    Atlanta, Georgia, 30342

  • Executive Health and Research Associates

    Atlanta, Georgia, 30342

  • Medical Specialist of the Palm Beaches

    Atlantis, Florida, 33462

  • Maine Research Associates

    Auburn, Maine, 04210

  • Southern Clinical Research and Management, Inc. (SCRAM)

    Augusta, Georgia, 30904

  • Masters of Clinical Research, Inc.

    Augusta, Georgia, 30909

  • Aurora Denver Cardiology Associates

    Aurora, Colorado, 80012

  • AMR Sakeena Research

    Aurora, Illinois, 60506

  • DCT-AACT, LLC dba Discovery Clinical Trials

    Austin, Texas, 78758

  • South Florida Medical Research

    Aventura, Florida, 33180

  • American Health Network of Indiana, LLC

    Avon, Indiana, 46123

  • Primary Care Cardiology Research

    Ayer, Massachusetts, 01432

  • Bina Akamdar MD

    Azusa, California, 91702

  • Kenneth F. Solinsky, MD

    Babylon, New York, 11702-2516

  • Amelia Medical Plaza

    Bainbridge, Georgia, 39819

  • Bainbridge Medical Associates

    Bainbridge, Georgia, 39819

  • Chesapeake CardioVascular Associates

    Baltimore, Maryland, 21204

  • Midatlantic Cardiovascular Associates

    Baltimore, Maryland, 21204

  • Midatlantic Cardiovascular Associates, PA

    Baltimore, Maryland, 21208

  • Health Trends Research, LLC

    Baltimore, Maryland, 21209

  • One Heart, LLC

    Baltimore, Maryland, 21215

  • Chesapeake CardioVascular Associates

    Baltimore, Maryland, 21218

  • Midatlantic Cardiovascular Associates, Pa

    Baltimore, Maryland, 21229

  • Saint Agnes HealthCare Incorporated

    Baltimore, Maryland, 21229

  • Stephen R Smith, MD FACP

    Baltimore, Maryland, 21234-4607

  • MidAtlantic Cardiovascular Associates, PA

    Baltimore, Maryland, 21237

  • Peter A. Holt

    Baltimore, Maryland, 21239

  • Great Lakes Research Group, Incorporated

    Bay City, Michigan, 48706

  • Southeast Texas Cardiology Associates

    Beaumont, Texas, 77702

  • Southeast Texas Clinical Research Center

    Beaumont, Texas, 77702

  • Tri-State Medical Group

    Beaver, Pennsylvania, 15009

  • Rheumatology and Pulmonary Clinic

    Beckley, West Virginia, 25801

  • Kaner Medical Group PA

    Bedford, Texas, 76021

  • Nexxus Research Group, LLC

    Bedford, Texas, 76021

  • Texas Orthopedic Specialists, PLLC

    Bedford, Texas, 76021

  • Midatlantic Cardiovascular Associates PA

    Bel Air, Maryland, 21014

  • Rx for Life, Inc

    Bell, California, 90201

  • Bellevue Family Practice/Clinical Research Advantage, Inc.

    Bellevue, Nebraska, 68005

  • Professional Clinical Research-Benzonia

    Benzonia, Michigan, 49616

  • Orthopaedics West

    Bessemer, Alabama, 35022

  • East Penn Rheumatology Associates, PC

    Bethlehem, Pennsylvania, 18015

  • Southern Maine Health Care

    Biddeford, Maine, 04005

  • The Center for Clinical Trials

    Biloxi, Mississippi, 39531

  • Central Alabama Research

    Birmingham, Alabama, 35209

  • Simon Williamson Clinic/Clinical Research Advantage, Inc.

    Birmingham, Alabama, 35211

  • Achieve Clinical Research, LLC

    Birmingham, Alabama, 35216

  • Alabama Clinical Therapeutics, LLC

    Birmingham, Alabama, 35235

  • Cahaba Research Inc.

    Birmingham, Alabama, 35242

  • Arthur I Davida, MD PC

    Bloomingdale, Illinois, 60108

  • RASF - Clinical Research Center

    Boca Raton, Florida, 33486

  • Orthopedic Health Care Clinic

    Boise, Idaho, 83702

  • Sonora Clinical Research, LLC

    Boise, Idaho, 83702

  • Eagle's View Family Medicine

    Boise, Idaho, 83713-0997

  • Chandler Family Practice

    Bossier City, Louisiana, 71111

  • Graves Gilbert Clinic

    Bowling Green, Kentucky, 42101-1759

  • Graves Gilbert Clinic

    Bowling Green, Kentucky, 42101

  • Orthopedic Research Institute

    Boynton Beach, Florida, 33472

  • Clinical Research of Brandon, LLC

    Brandon, Florida, 33511

  • Connecticut Clinical Research, LLC

    Bridgeport, Connecticut, 06606

  • Connecticut Gastroenterology Institute

    Bristol, Connecticut, 06010

  • Holston Medical Group

    Bristol, Tennessee, 37620

  • Internal Medicine & Pediatric Associates of Bristol

    Bristol, Tennessee, 37620

  • PMG Research of Bristol

    Bristol, Tennessee, 37620

  • LifeLine Research Institute

    Brooklyn, New York, 11214

  • Buckingham Family Medicine

    Buckingham, Pennsylvania, 18912

  • Highline Medical Center Laboratory

    Burien, Washington, 98166

  • Burke Internal Medicine & Research

    Burke, Virginia, 22015

  • Burke Internal Medicine

    Burke, Virginia, 22015

  • Kernodle Clinic Inc.

    Burlington, North Carolina, 27215

  • Cadillac Clinical Research

    Cadillac, Michigan, 49601

  • Abdul Bari MD Inc

    Cairo, Georgia, 39828

  • Southern Clinical Research Management and Consulting

    Cairo, Georgia, 39828

  • Calabash Medical Center

    Calabash, North Carolina, 28467

  • Camp Hill Clinical Research Center

    Camp Hill, Pennsylvania, 17011

  • Internal Medicine Research Association

    Campbellsville, Kentucky, 42718

  • Cape Girardeau Physicians Associates

    Cape Girardeau, Missouri, 63703

  • Clinical Research Advantage Inc., /Cassidy Medical Group-Carlsbad

    Carlsbad, California, 92008

  • Capitol Interventional Cardiology

    Carmichael, California, 95608

  • Northern California Research

    Carmichael, California, 95608

  • MedicalEdge Healthcare Group, PA, dba Leading Edge Research, PA

    Carrollton, Texas, 75007

  • PMG Research of Raleigh, LLC d/b/a PMG Research of Cary

    Cary, North Carolina, 27518

  • Physician's Clinic of Iowa, PC

    Cedar Rapids, Iowa, 52403

  • Clinical Research Advantage Inc./ Warner Family Practice, PC

    Chandler, Arizona, 85224

  • Chapel Hill Family Medicine

    Chapel Hill, North Carolina, 27514

  • Thurston Arthritis Reaserch Ctr

    Chapel Hill, North Carolina, 27599

  • Low Country Rheumatology, PA/Low Country Research Center

    Charleston, South Carolina, 29406-9333

  • Clinical Trials of South Carolina

    Charleston, South Carolina, 29406

  • St. Andrews Medical

    Charleston, South Carolina, 29407

  • Mid Carolina Cardiology Research

    Charlotte, North Carolina, 28204

  • Presbyterian Novant Heart and Wellness

    Charlotte, North Carolina, 28204

  • Arthritis and Osteoporosis Consultants of the Carolinas

    Charlotte, North Carolina, 28207-1198

  • PMG Research of Charlotte

    Charlotte, North Carolina, 28209-3734

  • Barat Research Group, Inc.

    Charlotte, North Carolina, 28262

  • Sensenbrenner Primary Care

    Charlotte, North Carolina, 28277

  • Shah Associates MD, LLC

    Charlotte Hall, Maryland, 20622

  • Center for Arthritis and Rheumatic Diseases

    Chesapeake, Virginia, 23320-4985

  • Bayview Physicians oa Cardiovascular Associates, Ltd

    Chesapeake, Virginia, 23320

  • David Ramstad, MD, MPH and Associates

    Chesapeake, Virginia, 23320

  • Cardiac Wellness Consultants

    Chicago, Illinois, 60611

  • Chicago Peripheral Nerve Center

    Chicago, Illinois, 60611

  • ICCT Research International Incorporated

    Chicago, Illinois, 60611

  • Claude Mandel Medical Center

    Chicago, Illinois, 60617

  • Butler Medical Associates

    Chicora, Pennsylvania, 16025

  • Family Healthcare of Chipley

    Chipley, Florida, 32428

  • Health First Clinical Research Group, Inc.

    Chipley, Florida, 32428

  • Southern Family Healthcare and Health First Research Group Inc.

    Chipley, Florida, 32428

  • CFP Research, Inc.

    Cincinnati, Ohio, 45242

  • Mountain State Clinical Research

    Clarksburg, West Virginia, 26301

  • Florida Research & Testing, LLC

    Clearwater, Florida, 33755

  • Alba Clinical Research

    Clearwater, Florida, 33756

  • Appletree Medical

    Clearwater, Florida, 33756

  • Innovative Research of West Florida, Inc.

    Clearwater, Florida, 33756

  • Clinical Research of West Florida

    Clearwater, Florida, 33765

  • Rapid Medical Research, Inc.

    Cleveland, Ohio, 44122

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • New Jersey Physicians, LLC

    Clifton, New Jersey, 07012

  • Clifton-Wallington Medical Group

    Clifton, New Jersey, 07013

  • Rameshwar N. Mathur, MD, PA

    Cocoa, Florida, 32927

  • Coeur D'Alene Arthritis Clinic

    Coeur d'Alene, Idaho, 83814

  • Perkiomen Valley Family Practice, PC

    Collegeville, Pennsylvania, 19426-3626

  • Prentiss Family Medicine

    Colleyville, Texas, 76034

  • Rheumatology Associates, Ltd

    Colmar, Pennsylvania, 18915

  • Azmi Emil Farag, MD

    Colorado Springs, Colorado, 80918

  • Lynn Institute of the Rockies

    Colorado Springs, Colorado, 80920

  • Colorado Springs Health Partners- East/Clinical Research Advantage

    Colorado Springs, Colorado, 80922

  • Cardiovascular Specialists, LLC

    Columbia, Maryland, 21044-2914

  • Johns Hopkins University

    Columbia, Maryland, 21044

  • Neem Research Group Inc.

    Columbia, South Carolina, 29201

  • Columbia Arthritis Center Pa

    Columbia, South Carolina, 29204

  • MedTrial

    Columbia, South Carolina, 29204

  • The Ohio State University

    Columbus, Ohio, 43210-1228

  • Feldman Family Practice

    Columbus, Ohio, 43213

  • MidWest Cardiology Research Foundation

    Columbus, Ohio, 43214

  • Riverside Methodist Hospital

    Columbus, Ohio, 43214

  • Remington-Davis Incorporated

    Columbus, Ohio, 43215

  • Midtowne Family Practice Centre

    Columbus, Ohio, 43228

  • Office of J. Miller Oppy, MD, Youghiogheny Primary Care Practice

    Connellsville, Pennsylvania, 15425

  • Carlos B. Everett, MD

    Corpus Christi, Texas, 78405

  • Discovery Clinical Research

    Corpus Christi, Texas, 78411

  • Ridge Family Practice, PC/Clinical Research Advantage, Inc.

    Council Bluffs, Iowa, 51503

  • New England Center for Clinical Research

    Cranston, Rhode Island, 02920

  • Nature Coast Clinical Research, LLC

    Crystal River, Florida, 34429

  • The Osteoporosis & Clinical Trials Center

    Cumberland, Maryland, 21502

  • Partners in Clinical Research

    Cumberland, Rhode Island, 02864

  • Texas Health Physicians Group

    Dallas, Texas, 75220

  • Soltero Cardiovascular Research Center/Baylor University Medical Center

    Dallas, Texas, 75226

  • Arthritis Care and Diagnostic Center, P.A.

    Dallas, Texas, 75231

  • Medical Specialists Associated

    Dallas, Texas, 75231

  • Metroplex Clinical Research Center

    Dallas, Texas, 75231

  • SouthWest Rheumatology, P.A.

    Dallas, Texas, 75231

  • DCT - Genesis Neighborhood Research, LLC dba Discovery Clinical Trials

    Dallas, Texas, 75254

  • Danville Internal Medicine, Inc.

    Danville, Virginia, 24541

  • Danville Orthopedic Clinic

    Danville, Virginia, 24541

  • Midwest Cardiovascular Research Foundation

    Davenport, Iowa, 52803

  • PriMed Clinical Research

    Dayton, Ohio, 45419

  • Atlantic Institute of Clinical Research

    Daytona Beach, Florida, 32114

  • International Medical Research

    Daytona Beach, Florida, 32117

  • Omega Research Consultants, LLC

    DeBary, Florida, 32713

  • Physicians Research Alliance, LLC

    DeBary, Florida, 32713

  • Deerfield Beach Cardiology Associates

    Deerfield Beach, Florida, 33442

  • Doctors Medical Center of Walton County

    DeFuniak Springs, Florida, 32435

  • Avail Clinical Research, LLC

    DeLand, Florida, 32720

  • Florida Research Associates, LLC/Florida Orthopaedic Associates, P.A.

    DeLand, Florida, 32720

  • Cohen Medical Associates, PA

    Delray Beach, Florida, 33446

  • Mountain View Clinical Research, Inc.

    Denver, Colorado, 80209

  • Office of Jerrold V Flatt

    Des Moines, Iowa, 50316

  • Clark Family Medicine & Emerald Coast Research Group

    Destin, Florida, 32540

  • SJS Clinical Research, Inc

    Destin, Florida, 32541

  • Livernois Family Medical Services

    Detroit, Michigan, 48221

  • Brandywine Clinical Research

    Downingtown, Pennsylvania, 19335

  • Medical Associates Clinic, PC

    Dubuque, Iowa, 52002

  • North Georgia Rheumatology Group, PC

    Duluth, Georgia, 30096

  • St. Luke's Hospital Association of Duluth, DBA St Luke's Rheumatology Assoc.

    Duluth, Minnesota, 55805

  • St. Luke's Hospital Association of Duluth, Inc.

    Duluth, Minnesota, 55805

  • St. Luke's Hospital Association of Duluth

    Duluth, Minnesota, 55805

  • Altoona Center for Clinical Research

    Duncansville, Pennsylvania, 16635

  • Robert W. Levin MD

    Dunedin, Florida, 34698

  • Lee Medical Associates

    Dunkirk, New York, 14048

  • Duke Health Center at Pickett Road

    Durham, North Carolina, 27705

  • CTL Research

    Eagle, Idaho, 83616

  • Office of Dr. Susan Courtnage

    Eaton Rapids, Michigan, 48827

  • Riverside Clinical Research

    Edgewater, Florida, 32132

  • Anderson and Collins, Clinical Research Inc.

    Edison, New Jersey, 08817

  • Drs. Collins and Uthappa

    Edison, New Jersey, 08817

  • Rajendra K. Marwah, MD

    El Paso, Texas, 79902

  • Central Jersey Health Care

    Elizabeth, New Jersey, 07202

  • Center for Arthritis and Osteoporosis

    Elizabethtown, Kentucky, 42701

  • Clinical Research Advantage, Inc./ Skyline Medical Center, PC

    Elkhorn, Nebraska, 68022

  • AMS Research

    Elmira, New York, 14905

  • CORE Orthopaedic Medical Center

    Encinitas, California, 92024

  • Regional Clinical Research, Inc.

    Endwell, New York, 13760

  • Andron Medical Associates

    Englewood, New Jersey, 07631-2507

  • HWC Women's Research Center

    Englewood, Ohio, 45322

  • Saint Vincent Consultant in Cardiovascular Diseases, LLC

    Erie, Pennsylvania, 16502

  • Arthritis Associates

    Erie, Pennsylvania, 16508

  • Center for Assessment and Research of Erie

    Erie, Pennsylvania, 16508

  • Stan F. Slabic, M.D.

    Erie, Pennsylvania, 16509

  • Arthritis Medical Clinic of North County, Inc.

    Escondido, California, 92025

  • Lane Medical Research Group

    Eugene, Oregon, 97401

  • Oregon Medical Group Adult Medicine Clinic

    Eugene, Oregon, 97401

  • Oregon Medical Group Clinical Research

    Eugene, Oregon, 97401

  • Kaner Medical Group, PA

    Euless, Texas, 76039

  • Windy City Orthopedics and Sports Medicine

    Evanston, Illinois, 60202

  • Robert D. Barnes, MD, LLC

    Evansville, Indiana, 47710

  • Clinical Research Advantage, Inc.

    Evansville, Indiana, 47714

  • Destiny Clinical Research, LLC

    Evansville, Indiana, 47714

  • Clinical Research Advantage/Family Medicine Associates

    Evansville, Indiana, 47725

  • Med Investigations, Inc.

    Fair Oaks, California, 95628

  • Cleveland Clinic Fairview Cardiovascular Medicine

    Fairview Park, Ohio, 44126

  • Genesis Clinical Research & Consulting

    Fall River, Massachusetts, 02720

  • NECCR Internal Medicine and Cardiology Associates, LLC

    Fall River, Massachusetts, 02720

  • Phase III Clinical Research

    Fall River, Massachusetts, 02720

  • Seven Corners Medical Research Center

    Falls Church, Virginia, 22044

  • Plains Clinical Research Center

    Fargo, North Dakota, 58104

  • Fayetteville Diagnostic Clinic Limited

    Fayetteville, Arkansas, 72703

  • Parkway Medical Group

    Fayetteville, Tennessee, 37334

  • AMH Feasterville Family HealthCare Center

    Feasterville, Pennsylvania, 19053

  • Fleming Island Center for Clinical Research

    Fleming Island, Florida, 32003

  • McLaren Regional Medical Center-Research Dept.

    Flint, Michigan, 48532

  • Clinical Research Associates, LLC

    Florence, South Carolina, 29501

  • Patterson Medical Clinic / d.b.a. Prime Care Research Associates

    Florissant, Missouri, 63031

  • Saint Luke's Medical Clinic

    Fort Collins, Colorado, 80525

  • Invesclinic

    Fort Lauderdale, Florida, 33308

  • M&O Clinical Research, LLC

    Fort Lauderdale, Florida, 33316

  • Maxine Hamilton, MD PA

    Fort Lauderdale, Florida, 33316

  • Holy Cross Medical Group Northridge Internal Medicine

    Fort Lauderdale, Florida, 33334

  • Clinical Physiology Associates

    Fort Myers, Florida, 33912

  • Emerald Coast Mood & Memory

    Fort Walton Beach, Florida, 32547

  • White-Wilson Medical Center, PA

    Fort Walton Beach, Florida, 32547

  • The Medical Group of Texas

    Fort Worth, Texas, 76104

  • Texas Health Physicians Group

    Fort Worth, Texas, 76107

  • T & R Clinic, P. A.

    Fort Worth, Texas, 76117

  • American Health Network of Indiana, LLC

    Franklin, Indiana, 46131

  • Prestige Clinical Research

    Franklin, Ohio, 45005

  • TriPhase Research, Ltd.

    Franklin, Ohio, 45005

  • Arthritis Treatment Center

    Frederick, Maryland, 21702

  • Clinical Research Advantage, Inc./Prairie Fields Family Medicine, PC

    Fremont, Nebraska, 68025

  • Valley Research

    Fresno, California, 93720

  • Cardiology West

    Gainesville, Florida, 32605

  • Florida Research Network, LLC

    Gainesville, Florida, 32605

  • Southeastern Integrated Medical, PL

    Gainesville, Florida, 32607

  • Shands at the University of Florida

    Gainesville, Florida, 32610

  • University of Florida

    Gainesville, Florida, 32610

  • United Osteoporosis Centers

    Gainesville, Georgia, 30501

  • Holzer Clinic, Inc

    Gallipolis, Ohio, 45631

  • Rheumatology-UTMB

    Galveston, Texas, 77555

  • Towngate Plaza Medical Center

    Garland, Texas, 75041

  • Internal Medicine Center of Northwest Indiana, P.C.

    Gary, Indiana, 46409

  • Stern Cardiovascular Foundation, inc.

    Germantown, Tennessee, 38138

  • ArthroCare, Arthritis Care & Research P.C.

    Gilbert, Arizona, 85234

  • Clinical Research Advantage Inc., /Thunderbird Internal Medicine

    Glendale, Arizona, 85306-4652

  • Arizona Center for Clinical Research

    Glendale, Arizona, 85306

  • Clinical Research Advantage, Inc./ Lenzmeier Family Medicine

    Glendale, Arizona, 85308

  • New West Physicians

    Golden, Colorado, 80401

  • Internal Medicine Associates, PC

    Grand Island, Nebraska, 68803

  • ProCare Clinical Trials

    Grand Prairie, Texas, 75052

  • Grand Valley Medical Specialist, PLC

    Grand Rapids, Michigan, 49506

  • Spectrum Health Medical Group-Rheumatology

    Grand Rapids, Michigan, 49506

  • Michigan Medical Cardiovascular PC

    Grand Rapids, Michigan, 49546

  • Beacon Medical Group Rheumatology

    Granger, Indiana, 46530

  • The Spine & Joint Center

    Greenbelt, Maryland, 20770

  • Creekside Clinical Research

    Greenbrae, California, 94904

  • American Health Network of IN, LLC

    Greenfield, Indiana, 46140-2834

  • Bland Clinic, PA

    Greensboro, North Carolina, 27401

  • Medication Management, LLC

    Greensboro, North Carolina, 27408

  • Westmoreland Neurology Associates, Incorporated

    Greensburg, Pennsylvania, 15601

  • Physicians East P. A.

    Greenville, North Carolina, 27834

  • Physicians East, PA

    Greenville, North Carolina, 27834

  • Palmetto Clinical Trial Services, LLC

    Greenville, South Carolina, 29601

  • Paris View Family Practice

    Greenville, South Carolina, 29601

  • John Milas

    Greer, South Carolina, 29650

  • Radiant Research, Inc

    Greer, South Carolina, 29650

  • DeGarmo Institute of Medical Research

    Greer, South Carolina, 29651

Other trials in United States

Canada67 sites

  • Office of Dr. Rohit Nagpal

    Brampton, Ontario, L6R 3A5

  • Aggarwal and Associates Ltd.

    Brampton, Ontario, L6T 3J1

  • Aviva Clinical Trial Group Inc.

    Burlington, Ontario, L7M 4Y1

  • South Calgary Medical Clinic - Sunpark Professional Center

    Calgary, Alberta, T2X 3X7

  • Centre de sante et de services sociaux de Chicoutimi

    Chicoutimi, Quebec, G7H 5H6

  • ECOGENE-21 / Centre de sante et de services sociaux de Chicoutimi

    Chicoutimi, Quebec, G7H 7P2

  • Corunna Medical Research Center

    Corunna, Ontario, N0N 1G0

  • Clinique de Medicine Familiale de Cowansville

    Cowansville, Quebec, J2K 2X9

  • Allin Clinic

    Edmonton, Alberta, T5K 2A2

  • Dr. MPJ Senaratne Professional Corporation

    Edmonton, Alberta, T6K 4C1

  • C & L Research

    Fort Erie, Ontario, L2A 1Z3

  • Office of Dr. Swaran K. Syan

    Greater Sudbury, Ontario, P3C 5K7

  • MSHJ Research Associates, Inc.

    Halifax, Nova Scotia, B3K 0A4

  • Office of Dr. Jonathan D. Adachi

    Hamilton, Ontario, L8N 1Y2

  • Medical Arts Health Research Group

    Kelowna, British Columbia, V1Y 3G8

  • Office of Dr. John Mutrie

    Kitchener, Ontario, N2E 4H9

  • KW Musculoskeletal Research Inc.

    Kitchener, Ontario, N2M 5N6

  • Centre de recherche clinique Adapra Inc.

    L'Ancienne-Lorette, Quebec, G2E 2X1

  • East London Medical Centre

    London, Ontario, N5W 3C6

  • London East Medical Centre

    London, Ontario, N5W 6A2

  • Office of Dr. Gordon Schacter

    London, Ontario, N5Y 5K7

  • Office of Dr. William Blake Bowler

    London, Ontario, N6A 3H5

  • Office of Dr. Robert G. Luton

    London, Ontario, N6A 5G6

  • Malton Medical Centre

    Mississauga, Ontario, L4T 4J2

  • G.A. Research Associates Ltd/Ltee

    Moncton, New Brunswick, E1G 1A7

  • Centre de Recherche Hochelaga/ Clinique Medicale Hochelaga

    Montreal, Quebec, H1L 2N9

  • Recherche Medicale Appliquee Informatics (AMIR) Inc.

    Montreal, Quebec, H3N 1S4

  • Commonwealth Medical Clinic

    Mount Pearl, Newfoundland and Labrador, A1N 1W7

  • The Arthritis Program Research Group Inc.

    Newmarket, Ontario, L3Y 3R7

  • SKDS Research Inc.

    Newmarket, Ontario, L3Y 5G8

  • Office of Dr. Azim M. Velji

    Niagara Falls, Ontario, L2E 7H1

  • AIM Health Group Trainyards Health and Wellness Centre

    Ottawa, Ontario, K1G 0Z3

  • Paradise Medical Clinic

    Paradise, Newfoundland and Labrador, A1L 1C6

  • The Medical Arts Health Research Group

    Penticton, British Columbia, V2A 5C8

  • Kells Medical Research Group, Inc.

    Pointe-Claire, Quebec, H9R 4S3

  • Recherche Clinique Sigma, Inc.

    Québec, Quebec, G1G 3Y8

  • Le Manoir de l'Atrium

    Québec, Quebec, G1H 7L3

  • Institut Universitaire de Cardiologie et de Pneumologie de Québec

    Québec, Quebec, G1V 4G5

  • Eric N. Grant Professional Corporation

    Quispamis, New Brunswick, E2E 4J8

  • Clinique Services Sante Rosemere

    Rosemère, Quebec, J7A 1K7

  • Office of Dr. Brian N. Craig

    Saint John, New Brunswick, E2K 2T8

  • St-Jerome Medical Research Inc.

    Saint-Jérôme, Quebec, J7Z 5T3

  • Centre Medical des Carrieres

    Saint-Marc-des-Carrieres, Quebec, G0A 4B0

  • London Road Diagnostic Clinic & Medical Center

    Sarnia, Ontario, N7T 4X3

  • London Road Diagnostic Clinic & Medical Centre

    Sarnia, Ontario, N7T 4X3

  • Downtown Medical Specialists

    Saskatoon, Saskatchewan, S7L 0Y7

  • White Hills Medical Clinic

    St. John's, Newfoundland and Labrador, A1A 3R5

  • Nexus Clinic Research

    St. John's, Newfoundland and Labrador, A1A 5E8

  • The Clinical Trials Centre

    St. John's, Newfoundland and Labrador, A1C 2H5

  • Topsail Road Medical Clinic

    St. John's, Newfoundland and Labrador, A1E 2E2

  • Ocean West Research Clinic Inc.

    Surrey, British Columbia, V3S 2N6

  • Keele Medical Place

    Toronto, Ontario, M3M 3E5

  • Prime Health Clinical Research

    Toronto, Ontario, M4S 1Y2

  • Office of Dr. Ira Bernstein

    Toronto, Ontario, M6A 3B5

  • Office of Dr. Subodh Kanani

    Toronto, Ontario, M8V 3X8

  • Manna Research

    Toronto, Ontario, M9W 4L6

  • Centre de Recherche Musculo-Squelettique

    Trois-Rivières, Quebec, G8Z 1Y2

  • Colchester Research Group

    Truro, Nova Scotia, B2N 1L2

  • Prohealth Clinical Research Inc.

    Vancouver, British Columbia, V5Z 4E1

  • Office of Dr. Milton F. Baker

    Victoria, British Columbia, V8P 5P6

  • The Medical Arts Health Research Group

    West Vancouver, British Columbia, V7T 2Z3

  • Cardiology and Research

    Westmount, Quebec, H3Z 2M6

  • North Walkerville Orthopaedic Associates

    Windsor, Ontario, N8W 1E6

  • Research Office

    Windsor, Ontario, N8W 1E6

  • Clinical Research and Arthritis Centre

    Windsor, Ontario, N8X 5A6

  • Rivergrove Medical Clinic

    Winnipeg, Manitoba, R2V 4W3

  • Manitoba Clinic

    Winnipeg, Manitoba, R3A 1M3

Other trials in Canada

Brazil33 sites

  • Centro de Ensino e Pesquisa Hospital Sao Lucas

    Aracaju, Sergipe, 49015-400

  • Hopsital das Clinicas da Universidade Federal de Minas Gerais

    Belo Horizonte, Minas Gerais, 30150-260

  • Hospital e Maternidade Angelina Caron, Sala Pesquisa Clinica

    Campina Grande do Sul, Paraná, 83430-000

  • Hospital e Maternidade Celso Pierro - Puc Campinas

    Campinas, São Paulo, 13059-740

  • PUC Campinas

    Campinas, São Paulo, 13059-740

  • Hospital das Clinicas da UNICAMP

    Campinas, São Paulo, 13083-888

  • CEPEME-CERHFAC Centro de Estudos e Pesquisas Medicas

    Curitiba, Paraná, 80030-220

  • Centro de Estudos do Hospital de Clínicas da UFPR

    Curitiba, Paraná, 80060-240

  • CIP - Centro Internacional de Pesquisas

    Goiânia, Goiás, 74110-120

  • Via Medica - Centro Clinico

    Goiânia, Goiás, 74223-130

  • Hospital Sao Salvador - Medicos Reunidos Ltda.

    Goiania-GO, 74110-020

  • CMIP - Centro Mineiro de Pesquisa

    Juiz de Fora, Minas Gerais, 36010-570

  • CLINCOR - Clinica de Exames Cardiologicos e Ecografia S/C Ltda

    Maceió, Alagoas, 57021-500

  • Hospital do Coracao de Alagoas

    Maceió, Alagoas, 57052-580

  • Hospital das Clinicas da Faculdade de Medicina de Marilia

    Marília, São Paulo, 17519-030

  • Ambulatorio de Especialidades Mario Covas

    Marilia/SP, 17519-000

  • Centro de Pesquisa Clinica

    Porto Alegre, Rio Grande do Sul, 90035-903

  • Associação Hospitalar Moinhos de Vento (AHMV) / CMIC

    Porto Alegre, Rio Grande do Sul, 90560-030

  • Hospital São Lucas - Pontificia

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Hospital Nossa Senhora da Conceicao

    Porto Alegre, RS, 91350-200

  • Hospital das Clinicas da UFPE

    Recife - Pernambuco, 52679-420

  • Hospital Universitário Clementino Fraga Filho - UFRJ

    Rio de Janeiro, Rio de Janeiro, 21941-913

  • CCBR Brasil Centro de Pesquisas e Analises Clinicas Ltda

    Rio de Janeiro, Rio de Janeiro, 22271-100

  • Hospital Ipanema Plus

    Rio de Janeiro, Rio de Janeiro, 22411-001

  • Clinica de Reumatologia do Centro Médico BarraShopping

    Rio de Janeiro, Rio de Janeiro, 22649-900

  • Hospital Dos Servidores Do Estado do Rio de Janeiro

    Rio de Janeiro, 20221-903

  • Faculdade de Medicina DO ABC

    Santo André, 09060-650

  • Hospital de Base - Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto

    São José do Rio Preto, São Paulo, 15090-000

  • CPCLIN - Centro de Pesquisas Clínicas

    São Paulo, São Paulo, 01244-030

  • Hospital Alemao Oswaldo Cruz

    São Paulo, São Paulo, 01323-903

  • Setor de Lip., Arterosc. e BioVasc. - Disc. de Cardiologia

    São Paulo, São Paulo, 04039-030

  • CEPIC - Centro Paulista de Investigacao Clínica

    São Paulo, São Paulo, 04266-010

  • IMA Brasil - Instituto de Medicina Avancada

    São Paulo, São Paulo, 05437-010

Other trials in Brazil

Ukraine19 sites

  • Municipal Medical Institution "City Clinical Hospital #3", Department of Rheumatology

    Chernivtsi, 58022

  • MI Dnipropetrovsk Regional Clinical Hospital named after I.I Mechnikov

    Dnipropetrovsk, 49005

  • State Institution "Dnipropetrovsk Medical Academy of MOH, Ukraine

    Dnipropetrovsk, 49005

  • Rheumatology Department, MMI "City Clinical Hospital #5", DNMU n.a. M.Gorkyy,

    Donetsk, 83001

  • Donetsk National Med University, Chair of Propaedeutics and Internal Medicine

    Donetsk, 83003

  • Municipal Establishment of Health Care

    Kharkiv, 61002

  • City Clinical Hospital # 8, Dept of Cardiology and Functional Diagnostics

    Kharkiv, 61178

  • City Clinical Hospital #1

    Kyiv, 02091

  • National Scientific Center "The Strazhesko Institute of Cardiology"

    Kyiv, 03680

  • State Institution "Republican clinical hospital of MOH of Ukraine"

    Kyiv, 04053

  • Family Medicine Department of NMAPE named after PL Shupyk,

    Kyiv, 04107

  • Lutsk City Clinical Hospital

    Lutsk, 43024

  • Municipal City Clinical Hospital #5

    Lviv, 79013

  • Center of Reconstructive and Regenerative Medicine (University clinic) of

    Odesa, 65009

  • CRI "Clinical Territorial Medical Association "University Clinic",

    Simferopol, Autonomous Republic of Crimea, 95017

  • Treatment-and-Diagnostic Center LLC "Desna" Ltd

    Ternopil, 46010

  • Municipal Institution "Zaporizhzhya City Multiple Discipline Clinical Hospital #9"

    Zaporizhzhya, 69065

  • Municipal enterprise " City Hospital # 7",

    Zaporizhzhya, 69118

  • Zhytomyr Regional Clinical Hospital n.a. O.F. Gerbachevs'kyy/ Rheumatology Center

    Zhytomyr, 10003

Other trials in Ukraine

Costa Rica16 sites

  • Centro Medico San Rafael

    Alajuela

  • Centro de Reumatologia y Osteoporosis

    Cartago, 30101

  • Clínica Garzona

    Cartago

  • Clinica San Agustin

    Desamparados Centro, Provincia de San José, 0000

  • Hospital CIMA San Jose

    Escazú, Provincia de San José

  • Hospital Hotel La Catolica

    Guadalupe, Provincia de San José

  • Clinica de Especialidades Medicas Drs. Saenz Castro

    Heredia

  • Clínica Monte Sión

    Heredia

  • Clínica San Antonio

    Heredia

  • Clínica Vía San Juan

    La Union de Tres Rios, Cartago Province, 30303

  • Consultorio Privado Dr. Alberto Lainez Ventosilla

    Moravia, Provincia de San José, 0000

  • Centro Medico San Jose

    San José

  • Edificio Panda

    San José

  • Hospital Clinica Biblica

    San José

  • Hospital Clínica Biblica

    San José

  • Oficina Privada

    San José

Other trials in Costa Rica

Australia12 sites

  • Wesley Medical Centre

    Auchenflower, Queensland, 4066

  • Hunter Clinical Research

    Broadmeadow, New South Wales, 2292

  • Australian Clinical Research Organisation

    Caboolture, Queensland, 4510

  • Rheumatology Department

    Cairns, Queensland, 4870

  • Monash Medical Centre, Department of Rheumatology

    Clayton, Victoria, 3168

  • Rheumatology Department

    Heidelberg West, Victoria, 3081

  • AusTrials Pty Ltd

    Kippa-Ring, Queensland, 4021

  • Emeritus Research

    Malvern East, Victoria, 3145

  • Core Research Group

    Milton, Queensland, 4064

  • The Goatcher Clinical Research Unit

    Shenton Park, Western Australia, 6008

  • AusTrials Pty Ltd

    Sherwood, Queensland, 4075

  • The Colin Bayliss Research and Teaching Unit

    Victoria Park, Western Australia, 6979

Other trials in Australia

Mexico11 sites

  • Instituto Jalisciense de Investigación Clínica SA de CV

    Guadalajara, Jalisco, 44160

  • Centro de Estudios de Investigacion Basica y Clinica SC.

    Guadalajara, Jalisco, 44690

  • Hospital Regional ISSSTE

    León, Guanajuato, 37520

  • Centro Medico Toluca

    Metepec, State of Mexico, 52140

  • Comite Mexicano para la Prevencion de la Osteoporosis, A.C.

    México, D.F., 06100

  • Instituto Mexicano de Investigación Clínica, S.A. de C.V

    México, D.F., 06700

  • CIF-BIOTEC, Medica Sur

    Mexico City, Mexico City, 14050

  • Clinicos Asociados BOCM, S.C.

    Mexico City, 03300

  • Unidad de Investigacion Dr. Mario Alvizouri Muñoz Ac Del Hospital General Dr. Miguel Silva

    Morelia, Michoacán, 58000

  • Hospital Central "Dr. Ignacio Morones Prieto" Unidad Regional de Reumatologia y Osteoporosis

    San Luis Potosí City, San Luis Potosí, 78240

  • Centro de Investigacion del Noroeste SC

    Tijuana, Estado de Baja California, 22010

Other trials in Mexico

Taiwan11 sites

  • Buddhist Tzu Chi Dailin General Hospital

    Chia-Yi County, Taiwan, 62247

  • Chang Gung Medical Foundation-Linkou Branch

    Gueishan Township, Taoyuan County, 333

  • Chung-Ho Memorial Hospital, Kaoshiung Medical University Hospital

    Kaohsiung City, 807

  • Tri-Service General Hospital

    Neihu District, Taipei CITY, 114

  • Chang Gung Memorial Hospital-Kaohsiung branch, Section of Allergy, Immunology

    Nio Sung Township, Kaohsiung County, 833

  • Chung Shan Medical University Hospital

    Taichung, 402

  • Taichung Veterans General Hospital

    Taichung, 40705

  • Chi-Mei Medical Center

    Tainan, YUNG KANG, 71004

  • National Taiwan University Hospital

    Taipei, 10018

  • Tri-service General Hospital

    Taipei, 100

  • Taipei Veterans General Hospital

    Taipei, 112

Other trials in Taiwan

Philippines8 sites

  • Chong Hua Hospital

    Cebu City, 6000

  • De La Salle Health Sciences Institute

    Dasmariñas, Cavite, 4114

  • Southern Philippines Medical Center

    Davao City, 8000

  • Mary Mediatrix Medical Center

    Lipa City, Batangas, 4217

  • Jose R. Reyes Memorial Medical Center

    Manila, 1003

  • Chinese General Hospital and Medical Center

    Manila, 1014

  • Hospital Research Unit, University of Santo Tomas Hospital

    Manila, 1015

  • St. Luke's Medical Center

    Quezon City, 1102

Other trials in Philippines

Colombia7 sites

  • Fundacion Cardioinfantil

    Bogota, Cundinamarca, 0

  • Clinica Colsanitas Sa

    Bogota, Cundinamarca

  • Fundacion Valle del Lili

    Cali, 760032

  • Fundacion Cardiovascular de Colombia

    Floridablanca, Santander Department

  • Hospital Pablo Tobon Uribe - Unidad de Investigaciones

    Medellín, Antioquia, 050034

  • Reumalab S.A.S.

    Medellín, Antioquia, 0

  • IPS Rodrigo Botero S.A.S.

    Medellín, Antioquia

Other trials in Colombia

Peru6 sites

  • Clinica San Felipe

    Lima, 11

  • Centro de Investigaciones Medical

    Lima, L29

  • Clinica San Juan Bautista

    Lima, Lima 36

  • IPC - Centro de Salud Integral S.A.

    San Isidro, Lima region, L 27

  • Centro Empresarial - Altavista Polo 4

    Santiago de Surco, Lima region, 00033

  • Instituto de Ginecologia y Reproducción & Cirugia Minimamente Invasiva

    Santiago de Surco, Lima region, 00033

Other trials in Peru

Hong Kong4 sites

  • Centre for Assessment and Treatment of Rheumatic Diseases, Department of Medicine and Geriatrics

    New Territories, NT

  • Department of Medicine, Queen Mary Hospital

    Pokfulam

  • Prince of Wales Hospital

    Shatin, NEW Territories

  • Department of Medicine, North District Hospital

    Sheung Shui, NT

Other trials in Hong Kong

Panama1 site

  • Centro de Investigación Marbella

    Panama City

Other trials in Panama

About this study

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

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.

Being tested
celecoxib, Ibuprofen, Naproxen
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • celecoxibDrug

    100 to 200 mg twice daily, taken by mouth

  • IbuprofenDrug

    ibuprofen 600 mg to 800 mg three times daily, taken by mouth

  • NaproxenDrug

    naproxen 375mg to 500 mg twice daily, taken by mouth

Study groups in NCT00346216
Study groupRoleWhat they receive
celecoxibExperimentalsubject receives celecoxib and dummy (placebo) ibuprofen and naproxen
Receives: Drug: celecoxib
ibuprofenActive comparatorsubject receives ibuprofen and dummy (placebo) celecoxib and naproxen
Receives: Drug: Ibuprofen
naproxenActive comparatorsubject receives naproxen and dummy (placebo) celecoxib and ibuprofen
Receives: Drug: Naproxen

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The First Occurrence of Antiplatelet Trialists Collaboration (APTC) Composite Endpoint, Confirmed by the Clinical Events Committee (CEC).

    APTC events are defined as a composite of any of the following events: Death due to CV causes (including cardiac, cerebrovascular, venous thromboembolic, haemorrhagic, other vascular, or unknown cause); Non-fatal MI; Non-fatal stroke (including intracranial hemorrhages, stroke of ischemic or unknown etiology).

    Measured: Intent to Treat (ITT) Population - 30 months; Modified ITT (MITT) Population - 42 months

Secondary outcomes (3)

  1. The First Occurrence of a Major Adverse Cardiovascular Events (MACE)

    MACE defined as the composite of CV death (including hemorrhagic death), non-fatal MI, non-fatal stroke, hospitalization for UA, revascularization or hospitalization for TIA

    Measured: ITT Population - 30 months; MITT Population - 42 months

  2. The First Occurrence of Clinically Significant Gastrointestinal Events (CSGIE)

    CSGIE include: Gastroduodenal (GD) hemorrhage, Gastric outlet obstruction, Gastroduodenal, small bowel or large bowel perforation, Large bowel hemorrhage, Small bowel hemorrhage, Acute GI hemorrhage of unknown origin, including presumed small bowel hemorrhage, Symptomatic gastric or duodenal ulcer

    Measured: ITT Population - 30 months; MITT Population - 42 months

  3. Change From Baseline in Patient's Assessment of Arthritis Pain (VAS)

    VAS question "How much pain do you have" was graded on a scale from 0 to 100 with 0 indicating "No pain" and 100 indicating "Worst possible pain".

    Measured: ITT and MITT Population - Baseline to 42 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jun 2006 (estimated)
  2. Study start4 Oct 2006
  3. Primary completion12 Apr 2016
  4. Study completion12 Apr 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
24,081 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00346216
Sponsor's protocol ID
A3191172
Other IDs
2004-002441-13, PRECISION TRIAL, 2004
Acronym
PRECISION
Status last verified
Mar 2021
First submitted
28 Jun 2006
Last updated
3 Mar 2021
Data monitoring committee
Yes

Publications

  • Agarwal N, St John J, Sunder V, Sarraju A, Laffin LJ. Association of Systolic Blood Pressure Time in Target Range With Cardiovascular Events Among PRECISION Participants. J Clin Hypertens (Greenwich). 2025 Jul;27(7):e70009. doi: 10.1111/jch.70009.

    PubMed 40627752

  • Obeid S, Libby P, Husni E, Wang Q, Wisniewski LM, Davey DA, Wolski KE, Xia F, Bao W, Walker C, Ruschitzka F, Nissen SE, Luscher TF. Cardiorenal risk of celecoxib compared with naproxen or ibuprofen in arthritis patients: insights from the PRECISION trial. Eur Heart J Cardiovasc Pharmacother. 2022 Sep 3;8(6):611-621. doi: 10.1093/ehjcvp/pvac015.

    PubMed 35234840

  • Chirikov VV, Walker C, Stephens JM, Schepman P, Chambers R, Bakir M, Poorman GW, Haider S, Farghaly M. Evaluating the Cost-Effectiveness of Celecoxib versus Ibuprofen and Naproxen in Patients with Osteoarthritis in United Arab Emirates Based on the PRECISION Trial. Clinicoecon Outcomes Res. 2021 May 19;13:409-420. doi: 10.2147/CEOR.S280556. eCollection 2021.

    PubMed 34040400

  • Bao W, Gaffney M, Pressler ML, Fayyad R, Wisemandle W, Beckerman B, Wolski KE, Nissen SE. Strengthening the interpretability of clinical trial results by assessing the effect of informative censoring on the primary estimand in PRECISION. Clin Trials. 2020 Oct;17(5):535-544. doi: 10.1177/1740774520934747. Epub 2020 Jul 9.

    PubMed 32643966

  • Solomon DH, Shao M, Wolski K, Nissen S, Husni ME, Paynter N. Derivation and Validation of a Major Toxicity Risk Score Among Nonsteroidal Antiinflammatory Drug Users Based on Data From a Randomized Controlled Trial. Arthritis Rheumatol. 2019 Aug;71(8):1225-1231. doi: 10.1002/art.40870. Epub 2019 Jun 12.

    PubMed 30801994

  • Reed GW, Abdallah MS, Shao M, Wolski K, Wisniewski L, Yeomans N, Luscher TF, Borer JS, Graham DY, Husni ME, Solomon DH, Libby P, Menon V, Lincoff AM, Nissen SE. Effect of Aspirin Coadministration on the Safety of Celecoxib, Naproxen, or Ibuprofen. J Am Coll Cardiol. 2018 Apr 24;71(16):1741-1751. doi: 10.1016/j.jacc.2018.02.036.

    PubMed 29673465

  • Solomon DH, Husni ME, Wolski KE, Wisniewski LM, Borer JS, Graham DY, Libby P, Lincoff AM, Luscher TF, Menon V, Yeomans ND, Wang Q, Bao W, Berger MF, Nissen SE; PRECISION Trial Investigators. Differences in Safety of Nonsteroidal Antiinflammatory Drugs in Patients With Osteoarthritis and Patients With Rheumatoid Arthritis: A Randomized Clinical Trial. Arthritis Rheumatol. 2018 Apr;70(4):537-546. doi: 10.1002/art.40400.

    PubMed 29266879

  • Ruschitzka F, Borer JS, Krum H, Flammer AJ, Yeomans ND, Libby P, Luscher TF, Solomon DH, Husni ME, Graham DY, Davey DA, Wisniewski LM, Menon V, Fayyad R, Beckerman B, Iorga D, Lincoff AM, Nissen SE. Differential blood pressure effects of ibuprofen, naproxen, and celecoxib in patients with arthritis: the PRECISION-ABPM (Prospective Randomized Evaluation of Celecoxib Integrated Safety Versus Ibuprofen or Naproxen Ambulatory Blood Pressure Measurement) Trial. Eur Heart J. 2017 Nov 21;38(44):3282-3292. doi: 10.1093/eurheartj/ehx508.

    PubMed 29020251

  • Nissen SE, Yeomans ND, Solomon DH, Luscher TF, Libby P, Husni ME, Graham DY, Borer JS, Wisniewski LM, Wolski KE, Wang Q, Menon V, Ruschitzka F, Gaffney M, Beckerman B, Berger MF, Bao W, Lincoff AM; PRECISION Trial Investigators. Cardiovascular Safety of Celecoxib, Naproxen, or Ibuprofen for Arthritis. N Engl J Med. 2016 Dec 29;375(26):2519-29. doi: 10.1056/NEJMoa1611593. Epub 2016 Nov 13.

    PubMed 27959716

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing celecoxib, Ibuprofen and Naproxen in people with Arthritis, Rheumatoid, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 1,066 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1,066 sites in United States, Canada, Brazil, Ukraine, Costa Rica and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The First Occurrence of Antiplatelet Trialists Collaboration (APTC) Composite Endpoint, Confirmed by the Clinical Events Committee (CEC). (time frame: Intent to Treat (ITT) Population - 30 months; Modified ITT (MITT) Population - 42 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00346216, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2021.

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