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Sponsors and Collaborators: |
University of Chieti Pfizer |
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Information provided by: | G. d'Annunzio University |
ClinicalTrials.gov Identifier: | NCT00565500 |
Study design: Single center, placebo-controlled, double blind, parallel groups. To evaluate the potential interaction between aspirin and ibuprofen or celecoxib in patients with osteoarthritis (OA) and documented stable ischemic heart disease, a total of 24 patients chronically treated with aspirin will be randomly assigned to one of the 3 treatment groups: 1) celecoxib 200 mg bid; 2) ibuprofen 600 mg tid; 3) placebo.
Condition | Intervention | Phase |
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Ischemic Heart Disease Osteoarthritis |
Drug: celecoxib Drug: ibuprofen Drug: placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Basic Science, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Pharmacodynamics Study |
Official Title: | A Placebo-Controlled, Double-Blind, Randomized Study of the Potential Interaction Between Aspirin and Ibuprofen or Celecoxib. |
Enrollment: | 24 |
Study Start Date: | April 2003 |
Study Completion Date: | April 2005 |
Arms | Assigned Interventions |
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1: Experimental |
Drug: celecoxib
celecoxib capsules 200 mg bid for 1 week
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2: Experimental |
Drug: ibuprofen
ibuprofen tablets 600 mg tid for 1 week
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3: Placebo Comparator |
Drug: placebo
placebo capsules tid for 1 week
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Patients with arthritis and vascular disease may receive both NSAIDs and lowdose aspirin for the secondary prevention of important vascular events.
The use of COX-2 inhibitors may have the potential advantage vs. nonselective NSAIDs in reducing the probability of interfering with permanent inactivation of COX-1 platelet by low-dose aspirin, in this setting. In fact, recent studies suggest that the likelihood of COX-inhibitors to present this pharmacodynamic interaction is inversely related to their COX-2 selectivity. Thus, differently from the non-selective NSAID ibuprofen, prior administration of the selective COX-2 inhibitor rofecoxib, does not antagonize the irreversible inhibition induced by aspirin in healthy subjects. Aim of this study is to determine whether celecoxib given at therapeutic dose at steady state alters the antiplatelet activity of low-dose aspirin, in comparison with ibuprofen.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Italy, CH | |
Ce.S.I., Center of Excellence on Aging, G. d'Annunzio University | |
Chieti, CH, Italy, 66100 |
Principal Investigator: | Raffaele De Caterina, MD, PhD | Institute of Cardiology, G. d'Annunzio University |
Responsible Party: | G. d'Annunzio University - Chieti ( Raffaele De Caterina, MD, PhD ) |
Study ID Numbers: | 635-IFL-0508-017, N49-98-71-900 |
Study First Received: | November 29, 2007 |
Last Updated: | November 29, 2007 |
ClinicalTrials.gov Identifier: | NCT00565500 History of Changes |
Health Authority: | Italy: Ethics Committee |
Anti-Inflammatory Agents Ibuprofen Heart Diseases Celecoxib Osteoarthritis Myocardial Ischemia Joint Diseases Cyclooxygenase Inhibitors Vascular Diseases Ischemia |
Rheumatic Diseases Musculoskeletal Diseases Aspirin Analgesics, Non-Narcotic Arthritis Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents |
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Osteoarthritis Myocardial Ischemia Physiological Effects of Drugs Musculoskeletal Diseases Sensory System Agents Arthritis Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Cardiovascular Diseases Analgesics Ibuprofen |
Celecoxib Heart Diseases Joint Diseases Cyclooxygenase Inhibitors Vascular Diseases Enzyme Inhibitors Rheumatic Diseases Pharmacologic Actions Analgesics, Non-Narcotic Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |