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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00346216
Recruitment Status : Completed
First Posted : June 29, 2006
Results First Posted : May 1, 2017
Last Update Posted : March 3, 2021
Sponsor:
Collaborator:
The Cleveland Clinic
Information provided by (Responsible Party):
Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )

Study Description
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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 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 or disease Intervention/treatment Phase
Arthritis, Rheumatoid Drug: celecoxib Drug: Ibuprofen Drug: Naproxen Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24081 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (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
Actual Study Start Date : October 4, 2006
Actual Primary Completion Date : April 12, 2016
Actual Study Completion Date : April 12, 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. The First Occurrence of Antiplatelet Trialists Collaboration (APTC) Composite Endpoint, Confirmed by the Clinical Events Committee (CEC). [ Time Frame: Intent to Treat (ITT) Population - 30 months; Modified ITT (MITT) Population - 42 months ]
    APTC events are defined as a composite of any of the following events: Death due to CV causes (including cardiac, cerebrovascular, venous thromboembolic, haemorrhagic, other vascular, or unknown cause); Non-fatal MI; Non-fatal stroke (including intracranial hemorrhages, stroke of ischemic or unknown etiology).


Secondary Outcome Measures :
  1. The First Occurrence of a Major Adverse Cardiovascular Events (MACE) [ Time Frame: ITT Population - 30 months; MITT Population - 42 months ]
    MACE defined as the composite of CV death (including hemorrhagic death), non-fatal MI, non-fatal stroke, hospitalization for UA, revascularization or hospitalization for TIA

  2. The First Occurrence of Clinically Significant Gastrointestinal Events (CSGIE) [ Time Frame: ITT Population - 30 months; MITT Population - 42 months ]
    CSGIE include: Gastroduodenal (GD) hemorrhage, Gastric outlet obstruction, Gastroduodenal, small bowel or large bowel perforation, Large bowel hemorrhage, Small bowel hemorrhage, Acute GI hemorrhage of unknown origin, including presumed small bowel hemorrhage, Symptomatic gastric or duodenal ulcer

  3. Change From Baseline in Patient's Assessment of Arthritis Pain (VAS) [ Time Frame: ITT and MITT Population - Baseline to 42 months ]
    VAS question "How much pain do you have" was graded on a scale from 0 to 100 with 0 indicating "No pain" and 100 indicating "Worst possible pain".


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00346216


Locations
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Sponsors and Collaborators
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
The Cleveland Clinic
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
ClinicalTrials.gov Identifier: NCT00346216    
Other Study ID Numbers: A3191172
2004-002441-13 ( EudraCT Number )
PRECISION TRIAL ( Other Identifier: Alias Study Number )
First Posted: June 29, 2006    Key Record Dates
Results First Posted: May 1, 2017
Last Update Posted: March 3, 2021
Last Verified: March 2021
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Ibuprofen
Celecoxib
Naproxen
Anti-Inflammatory Agents, Non-Steroidal
 Analgesics, Non-Narcotic
Analgesics
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