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Prospective Randomized Evaluation Of CelecoxibIntegrated Safety Vs Ibuprofen Or Naproxen

Sponsors: Pfizer
 

Purpose

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.

 
Condition
InterventionPhase
Arthritis, Rheumatoid OsteoarthritisDrug: celecoxib
Drug: Ibuprofen
Drug: Naproxen
PhaseIV

Study Type:Interventional
Study Design:Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety 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

 


 

 




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Eligibility

Ages Eligible for Study:18 Years and older
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:
  • Subjects have had a recent cardiovascular event, unstable cardiovascular conditions, or any major surgery (cardiac or non-cardiac) within 3 months prior to randomization;
  • Subjects with medical or laboratory abnormality that would make the subject inappropriate for entry into this trial
  • Subjects require treatment with aspirin > 325 mg /day
  • Subjects with known hypersensitivity to celecoxib, ibuprofen, naproxen, aspirin or esomeprazole, etc.
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Contacts

Physicians:
Ameer Kabour, MD
Raza Hashmi, MD
Tarif Kanaan, MD
Mohammad Alkhateeb, MD

Coordinators:
Brenda Hoagland, RN, CCRC
Michelle Hickam, RN, BSN
Julie Neidhardt, RN, BSN

Please contact us at 419-251-4919 for further information about this study.

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