Prospective Randomized Evaluation Of Celecoxib Integrated Safety Vs Ibuprofen Or Naproxen (PRECISION)

This study is ongoing, but not recruiting participants.
The Cleveland Clinic
Information provided by (Responsible Party):
Pfizer Identifier:
First received: June 28, 2006
Last updated: March 5, 2015
Last verified: March 2015

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 Intervention Phase
Arthritis, Rheumatoid
Drug: celecoxib
Drug: Ibuprofen
Drug: Naproxen
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • The first occurrence of cardiovascular death (including hemorrhagic death), non-fatal myocardial infarction, or non-fatal stroke (APTC composite endpoint). [ Time Frame: up to 18 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The occurrence of Clinical Significant Gastrointestinal Events (CSGIEs) [ Time Frame: up to 18 months ] [ Designated as safety issue: Yes ]
  • Patient's Assessment of Arthritis Pain (VAS) [ Time Frame: up to 18 months ] [ Designated as safety issue: Yes ]
  • 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 [ Time Frame: up to 18 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 24200
Study Start Date: October 2006
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: celecoxib
subject receives celecoxib and dummy (placebo) ibuprofen and naproxen
Drug: celecoxib
100 to 200 mg twice daily, taken by mouth
Active Comparator: ibuprofen
subject receives ibuprofen and dummy (placebo) celecoxib and naproxen
Drug: Ibuprofen
ibuprofen 600 mg to 800 mg three times daily, taken by mouth
Active Comparator: naproxen
subject receives naproxen and dummy (placebo) celecoxib and ibuprofen
Drug: Naproxen
naproxen 375mg to 500 mg twice daily, taken by mouth


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

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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Please refer to this study by its identifier: NCT00346216

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Sponsors and Collaborators
The Cleveland Clinic
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer Identifier: NCT00346216     History of Changes
Other Study ID Numbers: A3191172, 2004-002441-13, PRECISION TRIAL
Study First Received: June 28, 2006
Last Updated: March 5, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Arthritis, Rheumatoid
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Gout Suppressants
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses processed this record on March 25, 2015