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| Sponsor: | University of Chieti |
|---|---|
| Collaborator: |
Pfizer |
| Information provided by: | G. d'Annunzio University |
| ClinicalTrials.gov Identifier: | NCT00565500 |
Purpose
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 |
|---|---|---|
|
Ischemic Heart Disease Osteoarthritis |
Drug: celecoxib Drug: ibuprofen Drug: placebo |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Basic Science |
| 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 |
|---|---|
| Experimental: 1 |
Drug: celecoxib
celecoxib capsules 200 mg bid for 1 week
Other Name: celecoxib
|
| Experimental: 2 |
Drug: ibuprofen
ibuprofen tablets 600 mg tid for 1 week
Other Name: ibuprofen
|
| Placebo Comparator: 3 |
Drug: placebo
placebo capsules tid for 1 week
Other Name: placebo
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Italy | |
| 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 |
More Information
| Responsible Party: | Raffaele De Caterina, MD, PhD, G. d'Annunzio University - Chieti |
| ClinicalTrials.gov Identifier: | NCT00565500 History of Changes |
| Other Study ID Numbers: | 635-IFL-0508-017, N49-98-71-900 |
| Study First Received: | November 29, 2007 |
| Last Updated: | November 29, 2007 |
| Health Authority: | Italy: Ethics Committee |
|
Coronary Artery Disease Myocardial Ischemia Heart Diseases Osteoarthritis Coronary Disease Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases 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 Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Central Nervous System Agents Cyclooxygenase 2 Inhibitors |