Prospective Randomized Evaluation Of Celecoxib Integrated Safety Vs Ibuprofen Or Naproxen - Full Text View

Sponsor:	Pfizer
Collaborator:	The Cleveland Clinic
Information provided by (Responsible Party):	Pfizer
ClinicalTrials.gov Identifier:	NCT00346216

Purpose

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.

Condition	Intervention	Phase
Arthritis, Rheumatoid Osteoarthritis	Drug: celecoxib Drug: Ibuprofen Drug: Naproxen	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis Rheumatoid Arthritis

Drug Information available for: Ibuprofen Naproxen Naproxen sodium Ibuprofen lysinate Celecoxib

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

The occurrence of Clinical Significant Gastrointestinal Events (CSGIEs) [ Time Frame: up to 18 months ] [ Designated as safety issue: Yes ]
Patient's Assessment of Arthritis Pain (VAS) [ Time Frame: up to 18 months ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	20000
Study Start Date:	October 2006
Estimated Study Completion Date:	May 2014
Estimated Primary Completion Date:	May 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: celecoxib subject receives celecoxib and dummy (placebo) ibuprofen and naproxen	Drug: celecoxib 100 to 200 mg twice daily, taken by mouth
Active Comparator: ibuprofen subject receives ibuprofen and dummy (placebo) celecoxib and naproxen	Drug: Ibuprofen ibuprofen 600 mg to 800 mg three times daily, taken by mouth
Active Comparator: naproxen subject receives naproxen and dummy (placebo) celecoxib and ibuprofen	Drug: Naproxen naproxen 375mg to 500 mg twice daily, taken by mouth

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00346216

Contacts

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Show 863 Study Locations

Sponsors and Collaborators

Pfizer

The Cleveland Clinic

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT00346216 History of Changes
Other Study ID Numbers:	A3191172
Study First Received:	June 28, 2006
Last Updated:	May 9, 2012
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Arthritis
Arthritis, Rheumatoid
Cardiovascular Diseases
Osteoarthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Naproxen
Ibuprofen
Celecoxib
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic

Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents
Cyclooxygenase 2 Inhibitors

ClinicalTrials.gov processed this record on May 22, 2012