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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00346216




Registration number
NCT00346216
Ethics application status
Date submitted
28/06/2006
Date registered
29/06/2006
Date last updated
19/06/2017

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). - 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).
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) - 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
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) - 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
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) - 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".
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
Gender
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
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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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6979 - Victoria Park
Recruitment outside Australia
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pfizer
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/show/NCT00346216
Trial related presentations / publications
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
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Address 0 0
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Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications