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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
The Cleveland Clinic
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00346216
First received: June 28, 2006
Last updated: October 7, 2014
Last verified: October 2014

June 28, 2006
October 7, 2014
October 2006
December 2015   (final data collection date for primary outcome measure)
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 ]
The first occurrence of cardiovascular death (including hemorrhagic death), non-fatal myocardial infarction, or non-fatal stroke (APTC composite endpoint).
Complete list of historical versions of study NCT00346216 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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)
Not Provided
Not Provided
 
Prospective Randomized Evaluation Of Celecoxib Integrated Safety Vs Ibuprofen Or Naproxen
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

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Arthritis, Rheumatoid
  • Drug: celecoxib
    100 to 200 mg twice daily, taken by mouth
  • Drug: Ibuprofen
    ibuprofen 600 mg to 800 mg three times daily, taken by mouth
  • Drug: Naproxen
    naproxen 375mg to 500 mg twice daily, taken by mouth
  • Experimental: celecoxib
    subject receives celecoxib and dummy (placebo) ibuprofen and naproxen
    Intervention: Drug: celecoxib
  • Active Comparator: ibuprofen
    subject receives ibuprofen and dummy (placebo) celecoxib and naproxen
    Intervention: Drug: Ibuprofen
  • Active Comparator: naproxen
    subject receives naproxen and dummy (placebo) celecoxib and ibuprofen
    Intervention: Drug: Naproxen
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
24200
December 2015
December 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Brazil,   Canada,   Colombia,   Costa Rica,   Hong Kong,   Mexico,   Panama,   Peru,   Philippines,   Taiwan,   Ukraine
 
NCT00346216
A3191172, 2004-002441-13, PRECISION TRIAL
Yes
Pfizer
Pfizer
The Cleveland Clinic
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP