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

This study has been completed.
The Cleveland Clinic
Information provided by (Responsible Party):
Pfizer Identifier:
First received: June 28, 2006
Last updated: July 25, 2016
Last verified: July 2016
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
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, 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 ]

    Primary hypothesis: celecoxib is non-inferior to naproxen. A one-sided 97.5% confidence interval of the hazard ratio (HR) for each of the 3 comparisons (celecoxib:naproxen, ibuprofen:naproxen and celecoxib:ibuprofen) will be used.

    Non-inferiority to the specific comparative treatment will be demonstrated if the following 3 criteria are met:

    1. The one-sided 97.5% upper confidence limit of the HR is below the noninferiority margin of 1.33 for the ITT analysis; analysis of the ITT population will be truncated at 30 months to avoid the dilutional effect of premature treatment discontinuation.
    2. The point estimate of the HR for both the ITT and MITT analyses do not exceed 1.12;
    3. The one-sided 97.5% upper confidence limit of the HR is below the noninferiority margin of 1.40 based on a MITT analysis when subjects are censored 30 days after the last dose of study drug. For subjects who complete treatment (42 months) , the MITT analysis will be truncated at 42 months.

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

Enrollment: 24222
Study Start Date: October 2006
Study Completion Date: April 2016
Primary Completion Date: April 2016 (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   (Adult, Senior)
Sexes Eligible for Study:   All
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:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Pfizer Identifier: NCT00346216     History of Changes
Other Study ID Numbers: A3191172
2004-002441-13 ( EudraCT Number )
PRECISION TRIAL ( Other Identifier: Alias Study Number )
Study First Received: June 28, 2006
Last Updated: July 25, 2016

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase 2 Inhibitors
Gout Suppressants processed this record on April 26, 2017