AzTrials
AzTrials

OsteoarthritisPhase 4GI-REASONSNCT00373685

GI-Reasons- A Trial Of GI Safety Of Celecoxib Compared With Non-Selective Nonsteroidal Antiinflammatory Drugs (NSAIDS)

A Phase 4 study testing Celecoxib and Any commercially available NSAID with the indication for osteoarthritis in people with Osteoarthritis, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 777 sites in 2 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

This study investigates if Celebrex has a lower incident of Gastrointestinal Events than other NSAIDS in subjects with osteoarthritis. Read more about this study

Who is it for?
Ages 55 to 99 years
Conditions the study is for
Osteoarthritis
What is being tested?
Celecoxib and Any commercially available NSAID with the indication for osteoarthritis
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8,067 participants
Where
777 sitesin 2 countries
Study dates
Oct 2006to Nov 2010
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 55 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female patients of at least 55 years of age with a clinical diagnosis of OA who are expected to require daily prescription anti-inflammatory analgesic therapy for arthritis symptom management and for whom either celecoxib or a nsNSAID is an appropriate treatment option.

Who cannot join

  • GI ulcer hemorrhage or active GD ulceration less than 90 days prior to screening visit.
  • 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.

Trial locations and contacts

777 sites in 2 countries.

327 sites in 2 countries

United States300 sites

  • Pfizer Investigational Site

    ‘Aiea, Hawaii, 96701

  • Pfizer Investigational Site

    Abbeville, Alabama, 36310

  • Pfizer Investigational Site

    Akron, Ohio, 44310-1453

  • Pfizer Investigational Site

    Albany, New York, 12206

  • Pfizer Investigational Site

    Albuquerque, New Mexico, 87102

  • Pfizer Investigational Site

    Albuquerque, New Mexico, 87111

  • Pfizer Investigational Site

    Alexander City, Alabama, 35010

  • Pfizer Investigational Site

    Alexandria, Louisiana, 71301

  • Pfizer Investigational Site

    Alliance, Nebraska, 69301

  • Pfizer Investigational Site

    Altamonte Springs, Florida, 32701-4810

  • Pfizer Investigational Site

    Amarillo, Texas, 79106

  • Pfizer Investigational Site

    Ames, Iowa, 50010

  • Pfizer Investigational Site

    Anaheim, California, 92801

  • Pfizer Investigational Site

    Anaheim, California, 92804

  • Pfizer Investigational Site

    Anderson, South Carolina, 29621

  • Pfizer Investigational Site

    Annandale, Virginia, 22003

  • Pfizer Investigational Site

    Apopka, Florida, 32703

  • Pfizer Investigational Site

    Arkansas City, Kansas, 67005

  • Pfizer Investigational Site

    Arlington, Texas, 76017

  • Pfizer Investigational Site

    Arlington Heights, Illinois, 60004

  • Pfizer Investigational Site

    Asheboro, North Carolina, 27203

  • Pfizer Investigational Site

    Aston Mills, Pennsylvania, 19014

  • Pfizer Investigational Site

    Athens, Georgia, 30606

  • Pfizer Investigational Site

    Atlanta, Georgia, 30338

  • Pfizer Investigational Site

    Attleboro, Massachusetts, 02762

  • Pfizer Investigational Site

    Audubon, Pennsylvania, 19403

  • Pfizer Investigational Site

    Aurora, Colorado, 80012

  • Pfizer Investigational Site

    Austin, Texas, 78705

  • Pfizer Investigational Site

    Austin, Texas, 78750

  • Pfizer Investigational Site

    Avon, Connecticut, 06001

  • Pfizer Investigational Site

    Azle, Texas, 76020

  • Pfizer Investigational Site

    Bainbridge, Georgia, 39819

  • Pfizer Investigational Site

    Bakersfield, California, 93309

  • Pfizer Investigational Site

    Baltimore, Maryland, 21209

  • Pfizer Investigational Site

    Baltimore, Maryland, 21218

  • Pfizer Investigational Site

    Baltimore, Maryland, 21234-4607

  • Pfizer Investigational Site

    Baltimore, Maryland, 21286

  • Pfizer Investigational Site

    Baton Rouge, Louisiana, 70806

  • Pfizer Investigational Site

    Bay Minette, Alabama, 36507-4185

  • Pfizer Investigational Site

    Beatrice, Nebraska, 68310

  • Pfizer Investigational Site

    Bel Air, Maryland, 21015

  • Pfizer Investigational Site

    Bellevue, Washington, 98004

  • Pfizer Investigational Site

    Bellflower, California, 90706

  • Pfizer Investigational Site

    Belvidere, New Jersey, 07823

  • Pfizer Investigational Site

    Belzoni, Mississippi, 39038

  • Pfizer Investigational Site

    Bensalem, Pennsylvania, 19020

  • Pfizer Investigational Site

    Berkley, Michigan, 48072

  • Pfizer Investigational Site

    Berlin, New Jersey, 08009

  • Pfizer Investigational Site

    Bermuda Dunes, California, 92203

  • Pfizer Investigational Site

    Bethany, Oklahoma, 73008

  • Pfizer Investigational Site

    Bethlehem, Pennsylvania, 18015

  • Pfizer Investigational Site

    Beverly Hills, Florida, 34465

  • Pfizer Investigational Site

    Birmingham, Alabama, 35205

  • Pfizer Investigational Site

    Birmingham, Alabama, 35209

  • Pfizer Investigational Site

    Birmingham, Alabama, 35215

  • Pfizer Investigational Site

    Birmingham, Alabama, 35218

  • Pfizer Investigational Site

    Birmingham, Alabama, 35235

  • Pfizer Investigational Site

    Birmingham, Alabama, 35244

  • Pfizer Investigational Site

    Blackwood, New Jersey, 08012

  • Pfizer Investigational Site

    Bladensburg, Maryland, 20710

  • Pfizer Investigational Site

    Bluefield, Virginia, 24605

  • Pfizer Investigational Site

    Bluffton, South Carolina, 29910

  • Pfizer Investigational Site

    Boardman, Ohio, 44512

  • Pfizer Investigational Site

    Bolivar, Tennessee, 38008

  • Pfizer Investigational Site

    Boone, North Carolina, 28607

  • Pfizer Investigational Site

    Bountiful, Utah, 84010

  • Pfizer Investigational Site

    Bowling Green, Kentucky, 42104

  • Pfizer Investigational Site

    Boynton Beach, Florida, 33437

  • Pfizer Investigational Site

    Brewster, Connecticut, 06010

  • Pfizer Investigational Site

    Bridgeport, New Jersey, 08014

  • Pfizer Investigational Site

    Bridgeton, New Jersey, 08302

  • Pfizer Investigational Site

    Brighton, Michigan, 48116

  • Pfizer Investigational Site

    Bristol, Pennsylvania, 19007

  • Pfizer Investigational Site

    Broken Bow, Nebraska, 68822

  • Pfizer Investigational Site

    Brookfield, Connecticut, 06804

  • Pfizer Investigational Site

    Brooklyn, New York, 11203-2711

  • Pfizer Investigational Site

    Brooklyn, New York, 11224

  • Pfizer Investigational Site

    Broomall, Pennsylvania, 19008

  • Pfizer Investigational Site

    Brownsburg, Indiana, 46112

  • Pfizer Investigational Site

    Buena Park, California, 90620-3886

  • Pfizer Investigational Site

    Buena Park, California, 90620

  • Pfizer Investigational Site

    Bunn, North Carolina, 27508

  • Pfizer Investigational Site

    Burnsville, West Virginia, 26335

  • Pfizer Investigational Site

    Butler, Pennsylvania, 16001

  • Pfizer Investigational Site

    Cadillac, Michigan, 49601

  • Pfizer Investigational Site

    Cairo, Georgia, 39829

  • Pfizer Investigational Site

    Calhoun, Georgia, 30701

  • Pfizer Investigational Site

    Camp Hill, Pennsylvania, 17011

  • Pfizer Investigational Site

    Canton, Ohio, 44708

  • Pfizer Investigational Site

    Carlisle, Ohio, 45005

  • Pfizer Investigational Site

    Carnegie, Pennsylvania, 15106

  • Pfizer Investigational Site

    Carrollton, Texas, 75007

  • Pfizer Investigational Site

    Carrollton, Texas, 75010

  • Pfizer Investigational Site

    Carson, California, 90745

  • Pfizer Investigational Site

    Cartersville, Georgia, 30120

  • Pfizer Investigational Site

    Cedar Rapids, Iowa, 52401

  • Pfizer Investigational Site

    Centerville, Ohio, 45459

  • Pfizer Investigational Site

    Cerritos, California, 90703

  • Pfizer Investigational Site

    Chandler, Arizona, 85224

  • Pfizer Investigational Site

    Chardon, Ohio, 44024

  • Pfizer Investigational Site

    Charleston, South Carolina, 29414

  • Pfizer Investigational Site

    Charlotte, North Carolina, 28210

  • Pfizer Investigational Site

    Charlotte, North Carolina, 28262

  • Pfizer Investigational Site

    Chatham, Virginia, 24531

  • Pfizer Investigational Site

    Chattanooga, Tennessee, 37421

  • Pfizer Investigational Site

    Chelsea, Michigan, 48118

  • Pfizer Investigational Site

    Chesapeake, Virginia, 23320

  • Pfizer Investigational Site

    Chester, Pennsylvania, 19013

  • Pfizer Investigational Site

    Chesterland, Ohio, 44026

  • Pfizer Investigational Site

    Chicago, Illinois, 60628

  • Pfizer Investigational Site

    Chicora, Pennsylvania, 16025

  • Pfizer Investigational Site

    Chipley, Florida, 32428

  • Pfizer Investigational Site

    Chula Vista, California, 91910

  • Pfizer Investigational Site

    Cincinnati, Ohio, 45224

  • Pfizer Investigational Site

    Cincinnati, Ohio, 45236

  • Pfizer Investigational Site

    Cincinnati, Ohio, 45242

  • Pfizer Investigational Site

    City of Saint Peters, Missouri, 63376

  • Pfizer Investigational Site

    Clarkston, Michigan, 48346

  • Pfizer Investigational Site

    Clarksville, Tennessee, 37043

  • Pfizer Investigational Site

    Clearwater, Florida, 33755

  • Pfizer Investigational Site

    Clementon, New Jersey, 08021

  • Pfizer Investigational Site

    Clemson, South Carolina, 29631

  • Pfizer Investigational Site

    Clermont, Florida, 34711

  • Pfizer Investigational Site

    Cleveland, Ohio, 44103

  • Pfizer Investigational Site

    Clinton, South Carolina, 29325

  • Pfizer Investigational Site

    Clinton, Utah, 84015-8324

  • Pfizer Investigational Site

    Cocoa, Florida, 32927

  • Pfizer Investigational Site

    Cocoa Beach, Florida, 32931

  • Pfizer Investigational Site

    College Park, Maryland, 20740

  • Pfizer Investigational Site

    Colleyville, Texas, 76034

  • Pfizer Investigational Site

    Collierville, Tennessee, 38017

  • Pfizer Investigational Site

    Colorado Springs, Colorado, 80907

  • Pfizer Investigational Site

    Colorado Springs, Colorado, 80920

  • Pfizer Investigational Site

    Columbia, South Carolina, 29204

  • Pfizer Investigational Site

    Columbus, Georgia, 31904

  • Pfizer Investigational Site

    Columbus, Ohio, 43207

  • Pfizer Investigational Site

    Columbus, Ohio, 43212

  • Pfizer Investigational Site

    Columbus, Ohio, 43213

  • Pfizer Investigational Site

    Columbus, Ohio, 43215

  • Pfizer Investigational Site

    Columbus, Ohio, 43230-8703

  • Pfizer Investigational Site

    Coral Springs, Florida, 33065

  • Pfizer Investigational Site

    Corpus Christi, Texas, 78404

  • Pfizer Investigational Site

    Cortland, Ohio, 44410

  • Pfizer Investigational Site

    Cos Cob, Connecticut, 06807

  • Pfizer Investigational Site

    Covington, Georgia, 30016

  • Pfizer Investigational Site

    Cranston, Rhode Island, 02920

  • Pfizer Investigational Site

    Cresson, Pennsylvania, 16630

  • Pfizer Investigational Site

    Crystal River, Florida, 34429

  • Pfizer Investigational Site

    Cudahy, California, 90201

  • Pfizer Investigational Site

    Cullman, Alabama, 35058

  • Pfizer Investigational Site

    Cumming, Georgia, 30041

  • Pfizer Investigational Site

    Cutler Bay, Florida, 33189

  • Pfizer Investigational Site

    Dallas, Texas, 75208

  • Pfizer Investigational Site

    Dallas, Texas, 75220

  • Pfizer Investigational Site

    Dallas, Texas, 75224

  • Pfizer Investigational Site

    Dallas, Texas, 75231

  • Pfizer Investigational Site

    Dallastown, Pennsylvania, 17313

  • Pfizer Investigational Site

    Danville, Illinois, 61832

  • Pfizer Investigational Site

    Danville, Virginia, 24541

  • Pfizer Investigational Site

    Dauphin, Pennsylvania, 17018

  • Pfizer Investigational Site

    Davie, Florida, 33314

  • Pfizer Investigational Site

    Dawsonville, Georgia, 30534

  • Pfizer Investigational Site

    Dayton, Ohio, 45458

  • Pfizer Investigational Site

    Daytona Beach, Florida, 32114

  • Pfizer Investigational Site

    Daytona Beach, Florida, 32117

  • Pfizer Investigational Site

    Decatur, Georgia, 30033

  • Pfizer Investigational Site

    DeFuniak Springs, Florida, 32435

  • Pfizer Investigational Site

    DeKalb, Illinois, 60115

  • Pfizer Investigational Site

    DeLand, Florida, 32720

  • Pfizer Investigational Site

    Delaware, Ohio, 43015

  • Pfizer Investigational Site

    Denver, Colorado, 80206

  • Pfizer Investigational Site

    Denver, Colorado, 80209

  • Pfizer Investigational Site

    Denver, Colorado, 80219

  • Pfizer Investigational Site

    Des Moines, Iowa, 50315

  • Pfizer Investigational Site

    Des Moines, Iowa, 50316

  • Pfizer Investigational Site

    DeSoto, Texas, 75115

  • Pfizer Investigational Site

    Detroit, Michigan, 48221

  • Pfizer Investigational Site

    Dothan, Alabama, 36301

  • Pfizer Investigational Site

    Dothan, Alabama, 36303

  • Pfizer Investigational Site

    Downingtown, Pennsylvania, 19335

  • Pfizer Investigational Site

    Draffenville, Kentucky, 42025

  • Pfizer Investigational Site

    Dubuque, Iowa, 52002

  • Pfizer Investigational Site

    Duncansville, Pennsylvania, 16635

  • Pfizer Investigational Site

    Dunnellon, Florida, 34432

  • Pfizer Investigational Site

    Dunwoody, Georgia, 30338

  • Pfizer Investigational Site

    Durham, North Carolina, 27704

  • Pfizer Investigational Site

    East Providence, Rhode Island, 02914

  • Pfizer Investigational Site

    East Syracuse, New York, 13057

  • Pfizer Investigational Site

    Edmond, Oklahoma, 73034

  • Pfizer Investigational Site

    Egg Harbor, New Jersey, 08234

  • Pfizer Investigational Site

    El Cajon, California, 92019

  • Pfizer Investigational Site

    El Segundo, California, 90245

  • Pfizer Investigational Site

    Elgin, Illinois, 60123

  • Pfizer Investigational Site

    Elizabeth, New Jersey, 07201

  • Pfizer Investigational Site

    Elizabeth, New Jersey, 07202

  • Pfizer Investigational Site

    Elizabeth City, North Carolina, 27909

  • Pfizer Investigational Site

    Elkton, Maryland, 21921-5230

  • Pfizer Investigational Site

    Ellicott City, Maryland, 21042

  • Pfizer Investigational Site

    Elmhurst, New York, 11373

  • Pfizer Investigational Site

    Encino, California, 91436

  • Pfizer Investigational Site

    Erie, Pennsylvania, 16504

  • Pfizer Investigational Site

    Erie, Pennsylvania, 16508-1256

  • Pfizer Investigational Site

    Escondido, California, 92025-3406

  • Pfizer Investigational Site

    Evansville, Indiana, 47710-3807

  • Pfizer Investigational Site

    Evansville, Indiana, 47712

  • Pfizer Investigational Site

    Evergreen Park, Illinois, 60805

  • Pfizer Investigational Site

    Fair Haven, Michigan, 48023

  • Pfizer Investigational Site

    Fairborn, Ohio, 45324

  • Pfizer Investigational Site

    Fairview Heights, Illinois, 62208

  • Pfizer Investigational Site

    Fall River, Massachusetts, 02720

  • Pfizer Investigational Site

    Far Rockaway, New York, 11691

  • Pfizer Investigational Site

    Farmers Branch, Texas, 75234

  • Pfizer Investigational Site

    Fayetteville, New York, 13066

  • Pfizer Investigational Site

    Fenton, Michigan, 48430

  • Pfizer Investigational Site

    Flanders, New Jersey, 07836

  • Pfizer Investigational Site

    Fleetwood, Pennsylvania, 19522

  • Pfizer Investigational Site

    Flint, Michigan, 48507

  • Pfizer Investigational Site

    Florissant, Missouri, 63033

  • Pfizer Investigational Site

    Flossmoor, Illinois, 60422

  • Pfizer Investigational Site

    Flourtown, Pennsylvania, 19301

  • Pfizer Investigational Site

    Flushing, New York, 11355-2642

  • Pfizer Investigational Site

    Flushing, New York, 11358

  • Pfizer Investigational Site

    Fogelsville, Pennsylvania, 18051

  • Pfizer Investigational Site

    Forest Hills, New York, 11375

  • Pfizer Investigational Site

    Fort Collins, Colorado, 80525

  • Pfizer Investigational Site

    Fort Dodge, Iowa, 50501

  • Pfizer Investigational Site

    Fort Lauderdale, Florida, 33334

  • Pfizer Investigational Site

    Fort Myers, Florida, 33907

  • Pfizer Investigational Site

    Fort Wayne, Indiana, 46809

  • Pfizer Investigational Site

    Fort Worth, Texas, 76104

  • Pfizer Investigational Site

    Fort Worth, Texas, 76106

  • Pfizer Investigational Site

    Fort Worth, Texas, 76109

  • Pfizer Investigational Site

    Fort Worth, Texas, 76116

  • Pfizer Investigational Site

    Fort Worth, Texas, 76137

  • Pfizer Investigational Site

    Fortuna, California, 95540

  • Pfizer Investigational Site

    Franklin, Ohio, 45005

  • Pfizer Investigational Site

    Frederick, Maryland, 21702

  • Pfizer Investigational Site

    Freehold, New Jersey, 07728

  • Pfizer Investigational Site

    Fremont, California, 94536

  • Pfizer Investigational Site

    Fremont, Nebraska, 68025

  • Pfizer Investigational Site

    Fresno, California, 93710

  • Pfizer Investigational Site

    Fresno, California, 93726

  • Pfizer Investigational Site

    Frisco, Texas, 75034

  • Pfizer Investigational Site

    Gaffney, South Carolina, 29340

  • Pfizer Investigational Site

    Gainesville, Florida, 32605

  • Pfizer Investigational Site

    Gainesville, Georgia, 30501

  • Pfizer Investigational Site

    Garden Grove, California, 92843

  • Pfizer Investigational Site

    Garden Grove, California, 92845

  • Pfizer Investigational Site

    Garland, Texas, 75043

  • Pfizer Investigational Site

    Gastonia, North Carolina, 28056

  • Pfizer Investigational Site

    Geneva, Alabama, 36340

  • Pfizer Investigational Site

    Genoa, Ohio, 43430

  • Pfizer Investigational Site

    Germantown, Tennessee, 38138

  • Pfizer Investigational Site

    Glendale, Arizona, 85308

  • Pfizer Investigational Site

    Glendora, New Jersey, 08029

  • Pfizer Investigational Site

    Golden, Colorado, 80401

  • Pfizer Investigational Site

    Grand Island, Nebraska, 68803

  • Pfizer Investigational Site

    Grand Ledge, Michigan, 48837

  • Pfizer Investigational Site

    Grand Prairie, Texas, 75050

  • Pfizer Investigational Site

    Grand Prairie, Texas, 75052

  • Pfizer Investigational Site

    Grand Rapids, Michigan, 49546

  • Pfizer Investigational Site

    Grants Pass, Oregon, 97526

  • Pfizer Investigational Site

    Grapevine, Texas, 76051

  • Pfizer Investigational Site

    Green Cove Springs, Florida, 32043

  • Pfizer Investigational Site

    Green Valley, Arizona, 85614

  • Pfizer Investigational Site

    Greenbrae, California, 94904

  • Pfizer Investigational Site

    Greensboro, North Carolina, 27401

  • Pfizer Investigational Site

    Greensburg, Pennsylvania, 15601

  • Pfizer Investigational Site

    Greenville, Illinois, 62246

  • Pfizer Investigational Site

    Greenville, North Carolina, 27834

  • Pfizer Investigational Site

    Greenville, South Carolina, 29601-3973

  • Pfizer Investigational Site

    Greenville, South Carolina, 29601

  • Pfizer Investigational Site

    Greenville, South Carolina, 29605

  • Pfizer Investigational Site

    Greenville, South Carolina, 29615

  • Pfizer Investigational Site

    Greer, South Carolina, 29651

  • Pfizer Investigational Site

    Gulf Shores, Alabama, 36547

  • Pfizer Investigational Site

    Guntersville, Alabama, 35976

  • Pfizer Investigational Site

    Hallandale, Florida, 33009

  • Pfizer Investigational Site

    Hamden, Connecticut, 06518

  • Pfizer Investigational Site

    Hampton, Georgia, 30228

  • Pfizer Investigational Site

    Hampton, Virginia, 23666

  • Pfizer Investigational Site

    Hanna City, Illinois, 61536

  • Pfizer Investigational Site

    Harbor City, California, 90710

  • Pfizer Investigational Site

    Harrisburg, Pennsylvania, 17111

  • Pfizer Investigational Site

    Harrisburg, Pennsylvania, 17112

  • Pfizer Investigational Site

    Hartford, Kentucky, 42347

  • Pfizer Investigational Site

    Hatboro, Pennsylvania, 19040

  • Pfizer Investigational Site

    Hatfield, Pennsylvania, 19440

  • Pfizer Investigational Site

    Hattiesburg, Mississippi, 39402

  • Pfizer Investigational Site

    Hemet, California, 92543

  • Pfizer Investigational Site

    Henderson, Texas, 75652

  • Pfizer Investigational Site

    Hendersonville, Tennessee, 37075

  • Pfizer Investigational Site

    Hermiston, Oregon, 97838

  • Pfizer Investigational Site

    Hialeah, Florida, 33010

  • Pfizer Investigational Site

    Hialeah, Florida, 33013

  • Pfizer Investigational Site

    Hialeah, Florida, 33016

  • Pfizer Investigational Site

    Hinesville, Georgia, 31313

  • Pfizer Investigational Site

    Hobart, Indiana, 46342

  • Pfizer Investigational Site

    Hollywood, Florida, 33021

  • Pfizer Investigational Site

    Hollywood, Florida, 33023

Other trials in United States

Puerto Rico27 sites

  • Pfizer Investigational Site

    Aguas Buenas, PR, 00703

  • Pfizer Investigational Site

    Aguns Buenoas, PR, 00703

  • Pfizer Investigational Site

    Aibonito, PR, 00705

  • Pfizer Investigational Site

    Bayamón, PR, 00956

  • Pfizer Investigational Site

    Bayamón, PR, 00959

  • Pfizer Investigational Site

    Caguas, PR, 00725

  • Pfizer Investigational Site

    Carolina, PR, 00983

  • Pfizer Investigational Site

    Cayey, PR, 00736

  • Pfizer Investigational Site

    Cialis, PR, 00638

  • Pfizer Investigational Site

    Cidra, PR, 00739

  • Pfizer Investigational Site

    Hato Rey, PR, 00918

  • Pfizer Investigational Site

    Juncas, PR, 00777

  • Pfizer Investigational Site

    Juncos, PR, 00777

  • Pfizer Investigational Site

    Las Piedras, PR, 00771

  • Pfizer Investigational Site

    Levittown, PR, 00949

  • Pfizer Investigational Site

    Loiza, 00772

  • Pfizer Investigational Site

    Manati, PR, 00674

  • Pfizer Investigational Site

    Orocovis, 00720

  • Pfizer Investigational Site

    Rio Piedras, PR, 00921

  • Pfizer Investigational Site

    Rio Piedras, PR, 00926

  • Pfizer Investigational Site

    San Juan, PR, 00915

  • Pfizer Investigational Site

    San Juan, PR, 00921-1308

  • Pfizer Investigational Site

    San Juan, PR, 00924

  • Pfizer Investigational Site

    San Juan, PR, 00927

  • Pfizer Investigational Site

    Santa Isabel, PR, 00757

  • Pfizer Investigational Site

    Santurce, PR, 00908

  • Pfizer Investigational Site

    Trujillo Alto, PR, 00976

Other trials in Puerto Rico

About this study

Official title: Gastrointestinal (GI) Randomized Event And Safety Open-Label NSAID Study (GI-Reasons): A Randomized, Open-Label, Blinded-Endpoint, Parallel-Group Trial Of GI Safety Of Celecoxib Compared With Non-Selective Nonsteroidal Antiinflammatory Drugs (NSAIDS) In Osteoarthritis Patients

This study investigates if Celebrex has a lower incident of Gastrointestinal Events than other NSAIDS in subjects with osteoarthritis.

Conditions
Osteoarthritis
Being tested
Celecoxib, Any commercially available NSAID with the indication for osteoarthritis
Keywords
GI events in patients with moderate GI risk treated with NSAIDS
Medical subject headings
Osteoarthritis

What participants receive

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

  • CelecoxibDrug

    open-label

  • Any commercially available NSAID with the indication for osteoarthritisDrug

    dosing as per USPI label related to the chosen commercially marketed NSAID

Study groups in NCT00373685
Study groupRoleWhat they receive
CelecoxibExperimentaldosing as per USPI label
Receives: Drug: Celecoxib
NSAIDsActive comparatorNot described
Receives: Drug: Any commercially available NSAID with the indication for osteoarthritis

What is being measured

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

  1. Percentage of Participants With Clinically Significant Upper and/or Lower Gastrointestinal Events (CSULGIEs)

    CSULGIE defined as any of the following: gastroduodenal (GD) hemorrhage; gastric outlet obstruction; GD, small or large bowel perforation; small or large bowel hemorrhage; acute gastrointestinal (GI) hemorrhage of unknown origin; small bowel obstruction; clinically significant anemia/blood loss of defined GI origin or presumed occult GI origin.

    Measured: Baseline through week 24 or Early Termination (ET)

Secondary outcomes (11)

  1. Percentage of Participants With Moderate to Severe Abdominal Symptoms

    Abdominal symptoms coded using the Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) 'Gastrointestinal Disorders' high level group term (HLGT) equal to "Gastrointestinal Signs and Symptoms"; where moderate indicated the gastrointestinal adverse event (GI AE) interfered to some extent with the participants' usual function and severe indicated the GI AE interfered significantly with participants' usual function.

    Measured: Baseline through week 24 or ET

  2. Percentage of Participants Who Withdrew Due to GI Adverse Events (AEs)

    GI AEs defined using MedDRA SOC 'Gastrointestinal Disorders' but excluding HLGT's: Benign Neoplasms Gastrointestinal, Dental and Gingival Conditions, Oral Soft Tissue Conditions, Salivary Gland Conditions and Tongue Conditions

    Measured: Baseline through week 24 or ET

  3. Hemoglobin (Hb) at Baseline

    Measured: Baseline

  4. Change From Baseline Hb at Week 24

    Measured: Baseline and Week 24 or ET

  5. Hematocrit (Hct) at Baseline

    Measured: Baseline

  6. Change From Baseline Hct at Week 24

    Measured: Baseline and Week 24 or ET

  7. Percentage of Participants With Clinically Significant Decrease in Hct and/or Hb From Baseline

    Clinically significant decrease in Hct (greater than or equal to 10 percent [≥10%]) and/or decrease in Hb (≥ 2 g/dL).

    Measured: Baseline, Weeks 8, 16, 24 or ET

  8. Percentage of Participants Satisfied With Efficacy of Current Pain Medication Overall

    Percentage of participants who reported Very Satisfied or Satisfied with current pain medication question on the Patient Treatment Satisfaction Scale (PTSS), scale ranged from Very Satisfied (1) to Very Dissatisfied (5).

    Measured: Baseline, Weeks 8, 16, 24 or ET

  9. Percentage of Participants Satisfied With Efficacy of Current Pain Medication - Time to Pain Relief

    Percentage of participants who reported Very Satisfied or Satisfied with efficacy of current pain medication questions on the PTSS Efficacy subscale for the time it took medication to work, scale ranged from Very Satisfied (1) to Very Dissatisfied (5). Possible range of scores 1 to 15.

    Measured: Baseline, Weeks 8, 16, 24 or ET

  10. Percentage of Participants Satisfied With Efficacy of Current Pain Medication - Amount of Pain Relief

    Percentage of participants who reported Very Satisfied or Satisfied with efficacy of current pain medication questions on the PTSS Efficacy subscale for the amount of pain relief medication provided, scale ranged from Very Satisfied (1) to Very Dissatisfied (5). Possible range of scores 1 to 15.

    Measured: Baseline, Weeks 8, 16, 24 or ET

  11. Percentage of Participants Satisfied With Efficacy of Current Pain Medication - Duration of Pain Relief

    Percentage of participants who reported Very Satisfied or Satisfied with efficacy of current pain medication questions on the PTSS Efficacy, subscale for duration of pain relief provided by medication, scale ranged from Very Satisfied (1) to Very Dissatisfied (5). Possible range of scores 1 to 15.

    Measured: Baseline, Weeks 8, 16, 24 or ET

Timeline

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

  1. First posted8 Sep 2006 (estimated)
  2. Study startOct 2006
  3. Primary completionNov 2010
  4. Study completionNov 2010

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
None (open label)
Enrolment
8,067 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00373685
Sponsor's protocol ID
A3191331
Acronym
GI-REASONS
Status last verified
Mar 2021
First submitted
7 Sep 2006
Last updated
3 Mar 2021
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 23399552

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Celecoxib and Any commercially available NSAID with the indication for osteoarthritis in people with Osteoarthritis, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 777 sites in 2 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 2 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 777 sites in United States, Puerto Rico. 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 30 Nov 2011). 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?

Percentage of Participants With Clinically Significant Upper and/or Lower Gastrointestinal Events (CSULGIEs) (time frame: Baseline through week 24 or Early Termination (ET)). 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 NCT00373685, which also lists 1 linked publication.

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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