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

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ClinicalTrials.gov Identifier: NCT00346216
Recruitment Status : Completed
First Posted : June 29, 2006
Results First Posted : May 1, 2017
Last Update Posted : June 19, 2017
Sponsor:
Collaborator:
The Cleveland Clinic
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE June 28, 2006
First Posted Date  ICMJE June 29, 2006
Results First Submitted Date March 21, 2017
Results First Posted Date May 1, 2017
Last Update Posted Date June 19, 2017
Actual Study Start Date  ICMJE October 4, 2006
Actual Primary Completion Date April 12, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 21, 2017)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: June 28, 2006)
The first occurrence of cardiovascular death (including hemorrhagic death), non-fatal myocardial infarction, or non-fatal stroke (APTC composite endpoint).
Change History Complete list of historical versions of study NCT00346216 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 21, 2017)
  • 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".
Original Secondary Outcome Measures  ICMJE
 (submitted: June 28, 2006)
  • 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)
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Prospective Randomized Evaluation Of Celecoxib Integrated Safety Vs Ibuprofen Or Naproxen
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Arthritis, Rheumatoid
Intervention  ICMJE
  • 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
Study Arms
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 25, 2017)
24081
Original Enrollment  ICMJE
 (submitted: June 28, 2006)
20000
Actual Study Completion Date April 12, 2016
Actual Primary Completion Date April 12, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Brazil,   Canada,   Colombia,   Costa Rica,   Hong Kong,   Mexico,   Panama,   Peru,   Philippines,   Taiwan,   Ukraine,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00346216
Other Study ID Numbers  ICMJE A3191172
2004-002441-13 ( EudraCT Number )
PRECISION TRIAL ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE The Cleveland Clinic
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date May 2017

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