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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00346216
Registration number
NCT00346216
Ethics application status
Date submitted
28/06/2006
Date registered
29/06/2006
Date last updated
3/03/2021
Titles & IDs
Public title
Prospective Randomized Evaluation Of Celecoxib Integrated Safety Vs Ibuprofen Or Naproxen
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Scientific 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
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Secondary ID [1]
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2004-002441-13
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Secondary ID [2]
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A3191172
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Universal Trial Number (UTN)
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Trial acronym
PRECISION
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Arthritis, Rheumatoid
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0
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Condition category
Condition code
Musculoskeletal
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0
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0
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Osteoarthritis
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Inflammatory and Immune System
0
0
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0
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Rheumatoid arthritis
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - celecoxib
Treatment: Drugs - Ibuprofen
Treatment: Drugs - Naproxen
Experimental: celecoxib - subject receives celecoxib and dummy (placebo) ibuprofen and naproxen
Active comparator: ibuprofen - subject receives ibuprofen and dummy (placebo) celecoxib and naproxen
Active comparator: naproxen - subject receives naproxen and dummy (placebo) celecoxib and ibuprofen
Treatment: Drugs: celecoxib
100 to 200 mg twice daily, taken by mouth
Treatment: Drugs: Ibuprofen
ibuprofen 600 mg to 800 mg three times daily, taken by mouth
Treatment: Drugs: Naproxen
naproxen 375mg to 500 mg twice daily, taken by mouth
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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The First Occurrence of Antiplatelet Trialists Collaboration (APTC) Composite Endpoint, Confirmed by the Clinical Events Committee (CEC).
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Assessment method [1]
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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).
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Timepoint [1]
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Intent to Treat (ITT) Population - 30 months; Modified ITT (MITT) Population - 42 months
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Secondary outcome [1]
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The First Occurrence of a Major Adverse Cardiovascular Events (MACE)
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Assessment method [1]
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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
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Timepoint [1]
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ITT Population - 30 months; MITT Population - 42 months
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Secondary outcome [2]
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The First Occurrence of Clinically Significant Gastrointestinal Events (CSGIE)
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Assessment method [2]
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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
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Timepoint [2]
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ITT Population - 30 months; MITT Population - 42 months
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Secondary outcome [3]
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Change From Baseline in Patient's Assessment of Arthritis Pain (VAS)
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Assessment method [3]
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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".
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Timepoint [3]
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ITT and MITT Population - Baseline to 42 months
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
4/10/2006
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
12/04/2016
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Sample size
Target
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Accrual to date
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Final
24081
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
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Recruitment hospital [1]
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Hunter Clinical Research - Broadmeadow
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Wesley Medical Centre - Auchenflower
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Australian Clinical Research Organisation - Caboolture
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Rheumatology Department - Cairns
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AusTrials Pty Ltd - Kippa Ring
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Core Research Group - Milton
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AusTrials Pty Ltd - Sherwood
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Monash Medical Centre, Department of Rheumatology - Clayton
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Rheumatology Department - Heidelberg West
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Emeritus Research - Malvern East
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The Goatcher Clinical Research Unit - Shenton Park
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The Colin Bayliss Research and Teaching Unit - Victoria Park
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2292 - Broadmeadow
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4066 - Auchenflower
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4510 - Caboolture
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4870 - Cairns
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4021 - Kippa Ring
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4064 - Milton
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4075 - Sherwood
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3168 - Clayton
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3081 - Heidelberg West
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3145 - Malvern East
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6008 - Shenton Park
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Recruitment postcode(s) [12]
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6979 - Victoria Park
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Recruitment outside Australia
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Ukraine
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Zaporizhzhya
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Country [123]
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Ukraine
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Zhytomyr
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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Other collaborator category [1]
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Other
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The Cleveland Clinic
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Ethics approval
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT00346216
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Trial related presentations / publications
Obeid S, Libby P, Husni E, Wang Q, Wisniewski LM, Davey DA, Wolski KE, Xia F, Bao W, Walker C, Ruschitzka F, Nissen SE, Luscher TF. Cardiorenal risk of celecoxib compared with naproxen or ibuprofen in arthritis patients: insights from the PRECISION trial. Eur Heart J Cardiovasc Pharmacother. 2022 Sep 3;8(6):611-621. doi: 10.1093/ehjcvp/pvac015. Chirikov VV, Walker C, Stephens JM, Schepman P, Chambers R, Bakir M, Poorman GW, Haider S, Farghaly M. Evaluating the Cost-Effectiveness of Celecoxib versus Ibuprofen and Naproxen in Patients with Osteoarthritis in United Arab Emirates Based on the PRECISION Trial. Clinicoecon Outcomes Res. 2021 May 19;13:409-420. doi: 10.2147/CEOR.S280556. eCollection 2021. Bao W, Gaffney M, Pressler ML, Fayyad R, Wisemandle W, Beckerman B, Wolski KE, Nissen SE. Strengthening the interpretability of clinical trial results by assessing the effect of informative censoring on the primary estimand in PRECISION. Clin Trials. 2020 Oct;17(5):535-544. doi: 10.1177/1740774520934747. Epub 2020 Jul 9. Solomon DH, Shao M, Wolski K, Nissen S, Husni ME, Paynter N. Derivation and Validation of a Major Toxicity Risk Score Among Nonsteroidal Antiinflammatory Drug Users Based on Data From a Randomized Controlled Trial. Arthritis Rheumatol. 2019 Aug;71(8):1225-1231. doi: 10.1002/art.40870. Epub 2019 Jun 12. Reed GW, Abdallah MS, Shao M, Wolski K, Wisniewski L, Yeomans N, Luscher TF, Borer JS, Graham DY, Husni ME, Solomon DH, Libby P, Menon V, Lincoff AM, Nissen SE. Effect of Aspirin Coadministration on the Safety of Celecoxib, Naproxen, or Ibuprofen. J Am Coll Cardiol. 2018 Apr 24;71(16):1741-1751. doi: 10.1016/j.jacc.2018.02.036. Solomon DH, Husni ME, Wolski KE, Wisniewski LM, Borer JS, Graham DY, Libby P, Lincoff AM, Luscher TF, Menon V, Yeomans ND, Wang Q, Bao W, Berger MF, Nissen SE; PRECISION Trial Investigators. Differences in Safety of Nonsteroidal Antiinflammatory Drugs in Patients With Osteoarthritis and Patients With Rheumatoid Arthritis: A Randomized Clinical Trial. Arthritis Rheumatol. 2018 Apr;70(4):537-546. doi: 10.1002/art.40400. Ruschitzka F, Borer JS, Krum H, Flammer AJ, Yeomans ND, Libby P, Luscher TF, Solomon DH, Husni ME, Graham DY, Davey DA, Wisniewski LM, Menon V, Fayyad R, Beckerman B, Iorga D, Lincoff AM, Nissen SE. Differential blood pressure effects of ibuprofen, naproxen, and celecoxib in patients with arthritis: the PRECISION-ABPM (Prospective Randomized Evaluation of Celecoxib Integrated Safety Versus Ibuprofen or Naproxen Ambulatory Blood Pressure Measurement) Trial. Eur Heart J. 2017 Nov 21;38(44):3282-3292. doi: 10.1093/eurheartj/ehx508. Nissen SE, Yeomans ND, Solomon DH, Luscher 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.
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Public notes
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Contacts
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Pfizer CT.gov Call Center
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Pfizer
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
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Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00346216
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