Prospective Randomized Evaluation Of Celecoxib Integrated Safety Vs Ibuprofen Or Naproxen

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.24,081 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

24,081

Conditions

Arthritis, Rheumatoid

Interventions

celecoxibDRUG

100 to 200 mg twice daily, taken by mouth

IbuprofenDRUG

ibuprofen 600 mg to 800 mg three times daily, taken by mouth

NaproxenDRUG

naproxen 375mg to 500 mg twice daily, taken by mouth

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1066)

Outcomes

Primary Outcomes

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).

Time frame: Intent to Treat (ITT) Population - 30 months; Modified ITT (MITT) Population - 42 months

Secondary Outcomes

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

Time frame: ITT Population - 30 months; MITT Population - 42 months

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

Time frame: ITT Population - 30 months; MITT Population - 42 months

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".

Time frame: ITT and MITT Population - Baseline to 42 months

Data from ClinicalTrials.gov

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Carol M. Johnson MD, LLC

Alabaster, Alabama, United States

Orthopaedics West

Bessemer, Alabama, United States

Central Alabama Research