Phase 4
Completed N=24,081
Prospective Randomized Evaluation Of Celecoxib Integrated Safety Vs Ibuprofen Or Naproxen
Arthritis, Rheumatoid
Source: ClinicalTrials.gov NCT00346216 ↗
Enrolled (actual)
24,081
Serious AEs
19.7%
Results posted
May 2017
Primary outcomePrimary: The First Occurrence of Antiplatelet Trialists Collaboration (APTC) Composite Endpoint, Confirmed by the Clinical Events Committee (CEC). — 2.3; 2.7; 2.5; 1.7 Percentage of Partcipants — p=0.0002
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The First Occurrence of Antiplatelet Trialists Collaboration (APTC) Composite Endpoint, Confirmed by the Clinical Events Committee (CEC). |
2.3; 2.7; 2.5; 1.7; 1.9; 1.8 | 0.0002 sig |
| SECONDARY The First Occurrence of a Major Adverse Cardiovascular Events (MACE) |
4.2; 4.8; 4.3; 3.1; 3.6; 3.2 | 0.6427 |
| SECONDARY The First Occurrence of Clinically Significant Gastrointestinal Events (CSGIE) |
0.7; 0.9; 0.7; 0.3; 0.7; 0.7 | 0.8576 |
| SECONDARY Change From Baseline in Patient's Assessment of Arthritis Pain (VAS) |
54.0; 54.1; 54.1; -8.2; -9.0; -9.9 | <0.0001 sig |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00346216). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.