Status:

COMPLETED

Prospective Randomized Evaluation Of Celecoxib Integrated Safety Vs Ibuprofen Or Naproxen

Lead Sponsor:

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Collaborating Sponsors:

The Cleveland Clinic

Conditions:

Arthritis, Rheumatoid

Eligibility:

All Genders

18+ years

Phase:

PHASE4

Brief 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 ...

Eligibility Criteria

Inclusion

  • Subjects with osteoarthritis or rheumatoid Arthritis with or at risk of developing cardiovascular disease and who require and eligible for chronic, daily therapy with an NSAID to control arthritis sign and symptoms.

Exclusion

  • 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.

Key Trial Info

Start Date :

October 4 2006

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

April 12 2016

Estimated Enrollment :

24081 Patients enrolled

Trial Details

Trial ID

NCT00346216

Start Date

October 4 2006

End Date

April 12 2016

Last Update

March 3 2021

Active Locations (1066)

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Page 1 of 267 (1066 locations)

1

Carol M. Johnson MD, LLC

Alabaster, Alabama, United States, 35007

2

Orthopaedics West

Bessemer, Alabama, United States, 35022

3

Central Alabama Research

Birmingham, Alabama, United States, 35209

4

Simon Williamson Clinic/Clinical Research Advantage, Inc.

Birmingham, Alabama, United States, 35211