PRECISION : Prospective Randomized Evaluation of Celecoxib Integrated Safety vs Ibuprofen Or Naproxen

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.

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

Conditions

OsteoarthritisArthritis, Rheumatoid

Study Type

Interventional

Study Design

Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety Study

Further Details

Primary Outcome Measures:

• The first occurrence of cardiovascular death (including hemorrhagic death), non-fatal myocardial infarction, or non-fatal stroke (APTC composite endpoint).

Secondary Outcome Measures:

• The first occurrence of a MACE defined as the composite of cardiovascular death (including hemorrhagic death), non-fatal MI, non-fatal stroke, hospitalization for UA, revascularization or hospitalization for TIA
• The occurrence of Clinical Significant Gastrointestinal Events (CSGIEs)
• Patient’s Assessment of Arthritis Pain (VAS)

Study Start

October 2006

Eligibility & Criteria

• Ages Eligible for Study: 18 Years and above
• Genders Eligible for Study: Both

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.

Total Enrolment

20000

Contact Details

• Pfizer Investigational Site, Geelong, Victoria, 3220, Australia; Recruiting

Contact Pfizer for more information.