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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
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
Secondary ID [1] 0 0
2004-002441-13
Secondary ID [2] 0 0
A3191172
Universal Trial Number (UTN)
Trial acronym
PRECISION
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Arthritis, Rheumatoid 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
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

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The First Occurrence of Antiplatelet Trialists Collaboration (APTC) Composite Endpoint, Confirmed by the Clinical Events Committee (CEC).
Timepoint [1] 0 0
Intent to Treat (ITT) Population - 30 months; Modified ITT (MITT) Population - 42 months
Secondary outcome [1] 0 0
The First Occurrence of a Major Adverse Cardiovascular Events (MACE)
Timepoint [1] 0 0
ITT Population - 30 months; MITT Population - 42 months
Secondary outcome [2] 0 0
The First Occurrence of Clinically Significant Gastrointestinal Events (CSGIE)
Timepoint [2] 0 0
ITT Population - 30 months; MITT Population - 42 months
Secondary outcome [3] 0 0
Change From Baseline in Patient's Assessment of Arthritis Pain (VAS)
Timepoint [3] 0 0
ITT and MITT Population - Baseline to 42 months

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Hunter Clinical Research - Broadmeadow
Recruitment hospital [2] 0 0
Wesley Medical Centre - Auchenflower
Recruitment hospital [3] 0 0
Australian Clinical Research Organisation - Caboolture
Recruitment hospital [4] 0 0
Rheumatology Department - Cairns
Recruitment hospital [5] 0 0
AusTrials Pty Ltd - Kippa Ring
Recruitment hospital [6] 0 0
Core Research Group - Milton
Recruitment hospital [7] 0 0
AusTrials Pty Ltd - Sherwood
Recruitment hospital [8] 0 0
Monash Medical Centre, Department of Rheumatology - Clayton
Recruitment hospital [9] 0 0
Rheumatology Department - Heidelberg West
Recruitment hospital [10] 0 0
Emeritus Research - Malvern East
Recruitment hospital [11] 0 0
The Goatcher Clinical Research Unit - Shenton Park
Recruitment hospital [12] 0 0
The Colin Bayliss Research and Teaching Unit - Victoria Park
Recruitment postcode(s) [1] 0 0
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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6979 - Victoria Park
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Zhytomyr

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The Cleveland Clinic
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT00346216
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.
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00346216