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

This study has been completed.
Sponsor:
Collaborator:
The Cleveland Clinic
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00346216
First received: June 28, 2006
Last updated: May 25, 2017
Last verified: May 2017
June 28, 2006
May 25, 2017
October 4, 2006
April 12, 2016   (Final data collection date for primary outcome measure)
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).
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 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
  • 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
  • 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".
  • 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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
Nissen SE, Yeomans ND, Solomon DH, Lüscher TF, Libby P, Husni ME, Graham DY, Borer JS, Wisniewski LM, Wolski KE, Wang Q, Menon V, Ruschitzka F, Gaffney M, Beckerman B, Berger MF, Bao W, Lincoff AM; PRECISION Trial Investigators. Cardiovascular Safety of Celecoxib, Naproxen, or Ibuprofen for Arthritis. N Engl J Med. 2016 Dec 29;375(26):2519-29. doi: 10.1056/NEJMoa1611593. Epub 2016 Nov 13.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24081
April 12, 2016
April 12, 2016   (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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Brazil,   Canada,   Colombia,   Costa Rica,   Hong Kong,   Mexico,   Panama,   Peru,   Philippines,   Taiwan,   Ukraine,   United States
 
 
NCT00346216
A3191172
2004-002441-13 ( EudraCT Number )
PRECISION TRIAL ( Other Identifier: Alias Study Number )
Yes
Not Provided
Not Provided
Pfizer
Pfizer
The Cleveland Clinic
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2017

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