Overview

This trial is active, not recruiting.

Condition arthritis, rheumatoid
Treatments celecoxib, ibuprofen, naproxen
Phase phase 4
Sponsor Pfizer
Collaborator The Cleveland Clinic
Start date October 2006
End date March 2016
Trial size 24200 participants
Trial identifier NCT00346216, 2004-002441-13, A3191172, PRECISION TRIAL

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
Arm
(Experimental)
subject receives celecoxib and dummy (placebo) ibuprofen and naproxen
celecoxib
100 to 200 mg twice daily, taken by mouth
(Active Comparator)
subject receives ibuprofen and dummy (placebo) celecoxib and naproxen
ibuprofen
ibuprofen 600 mg to 800 mg three times daily, taken by mouth
(Active Comparator)
subject receives naproxen and dummy (placebo) celecoxib and ibuprofen
naproxen
naproxen 375mg to 500 mg twice daily, taken by mouth

Primary Outcomes

Measure
The first occurrence of cardiovascular death (including hemorrhagic death), non-fatal myocardial infarction, or non-fatal stroke (APTC composite endpoint).
time frame: up to 18 months

Secondary Outcomes

Measure
The occurrence of Clinical Significant Gastrointestinal Events (CSGIEs)
time frame: up to 18 months
Patient's Assessment of Arthritis Pain (VAS)
time frame: up to 18 months
The first occurrence of a MACE defined as the composite of cardiovascular death (including hemorrhagic death), non-fatal MI, non-fatal stroke, hospitalization for UA, revascularization or hospitalization for TIA
time frame: up to 18 months

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official 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
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Pfizer.