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

This study is currently recruiting participants.
Verified June 2013 by Pfizer
Sponsor:
Collaborator:
The Cleveland Clinic
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00346216
First received: June 28, 2006
Last updated: June 13, 2013
Last verified: June 2013
History of Changes
  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 Intervention Phase
Arthritis, Rheumatoid
Osteoarthritis
 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:

U.S. FDA Resources

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: 20000
Study Start Date: October 2006
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 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

  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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00346216

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

  Show 883 Study Locations
Sponsors and Collaborators
Pfizer
The Cleveland Clinic
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00346216     History of Changes
Other Study ID Numbers: A3191172
Study First Received: June 28, 2006
Last Updated: June 13, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on June 17, 2013