Prospective Randomized Evaluation Of Celecoxib Integrated Safety Vs Ibuprofen Or Naproxen

Phase 4

Completed

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
ibuprofen	Ibuprofen	subject receives ibuprofen and dummy (placebo) celecoxib and naproxen
celecoxib	celecoxib	subject receives celecoxib and dummy (placebo) ibuprofen and naproxen
naproxen	Naproxen	subject receives naproxen and dummy (placebo) celecoxib and ibuprofen

Primary Outcome Measures

Name	Time	Method
The First Occurrence of Antiplatelet Trialists Collaboration (APTC) Composite Endpoint, Confirmed by the Clinical Events Committee (CEC).	Intent to Treat (ITT) Population - 30 months; Modified ITT (MITT) Population - 42 months	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).

Secondary Outcome Measures

Name	Time	Method
The First Occurrence of a Major Adverse Cardiovascular Events (MACE)	ITT Population - 30 months; MITT Population - 42 months	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
The First Occurrence of Clinically Significant Gastrointestinal Events (CSGIE)	ITT Population - 30 months; MITT Population - 42 months	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
Change From Baseline in Patient's Assessment of Arthritis Pain (VAS)	ITT and MITT Population - Baseline to 42 months	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".

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Alabaster, Alabama, United States
Orthopaedics West
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Simon Williamson Clinic/Clinical Research Advantage, Inc.
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Alabama Clinical Therapeutics, LLC
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Cahaba Research Inc.
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Winston Technology Inc.
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Clinical Research Consultants, Inc
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Hoover, Alabama, United States
Medical Affiliated Research Center, Incorporated
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Huntsville, Alabama, United States
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Carol M. Johnson MD, LLC
🇺🇸Alabaster, Alabama, United States