Prospective Randomized Evaluation Of Celecoxib Integrated Safety Vs Ibuprofen Or Naproxen
NCT00346216
Last updated date
ABOUT THIS STUDY
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.
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
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
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.
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
Rheumatoid ArthritisEvaluation of Pain Sensitization in Rheumatoid Arthritis: Analysis on a Cohort of Tofacitinib Treated Patients
NCT03815578
- Bordeaux,
- Limoges,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Rheumatoid ArthritisCONfident Treatment Decisions in Living With Rheumatoid Arthritis
NCT03317756
- Birmingham, Alabama
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Rheumatoid ArthritisEffect of the Inhibitors of the Way JAK-STAT on Regulatory B Cells
NCT03755297
- Montpellier,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Rheumatoid ArthritisRheumatoid Arthritis DMARD Intervention and UtilizationStudy
NCT00116727
ALL GENDERS
18 Years+
years
MULTIPLE SITES
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 |
| |||
| Study Arms ICMJE |
| |||
| 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 | 24081 | |||
| Original Enrollment ICMJE | 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:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| 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 |
| |||
| 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 | ||||