Prospective Randomized Evaluation Of Celecoxib Integrated Safety Vs Ibuprofen Or Naproxen

NCT00346216

Last updated date
Study Location
Carol M. Johnson MD, LLC
Alabaster, Alabama, 35007, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Rheumatoid Arthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Advanced Information
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  ICMJE 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  ICMJE
  • 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  ICMJE 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  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE 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  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE The Cleveland Clinic
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
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