Celecoxib, Ibuprofen and the Antiplatelet Effect of Aspirin

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by:
G. d'Annunzio University
ClinicalTrials.gov Identifier:
NCT00565500
First received: November 29, 2007
Last updated: NA
Last verified: November 2007
History: No changes posted
  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 4

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.

Resource links provided by NLM:


Further study details as provided by G. d'Annunzio University:

Primary Outcome Measures:
  • serum thromboxane (TX)B2 [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • urinary 11-dehydro-thromboxane (TX)B2, arachidonic acid- and ADP-induced platelet aggregation by Born's aggregometer, whole-blood aggregation in the platelet function analyzer (PFA) system, LPS-stimulated prostaglandin(PG)E2 [ Time Frame: 1 week ] [ Designated as safety issue: No ]

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

Detailed Description:

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
Criteria

Inclusion Criteria:

  1. male or female, age 18-75;
  2. subjects with osteoarthritis and documented stable ischemic heart disease;
  3. the patient is on long-term aspirin prophylaxis for the ischemic condition;
  4. the patient requires or is eligible for chronic treatment with an antiinflammatory and/or analgesic drugs given to control osteoarthritis symptoms;
  5. female subjects of childbearing potential must have a negative pregnancy test, use adequate contraception during the study and not be lactating;
  6. written informed consent before undergoing any study procedure.

Exclusion Criteria:

  1. active gastrointestinal disease (e.g. Crohn's disease or ulcerative colitis) or any evidence of concomitant disease which may lead to early termination of the study;
  2. history of active peptic ulceration, gastrointestinal bleeding, esophageal, gastric or duodenal ulcer;
  3. known hypersensitivity to COX-2 inhibitors, analgesics, antipyretics, sulfonamides or NSAIDs;
  4. treatment with any investigational drug within the previous 30 days;
  5. previous participation in this study;
  6. evidence of neoplasm or any other severe disease of any organ, including any psychiatric illness;
  7. clinically relevant deviations from the normal range in laboratory tests;
  8. recent history or suspicion of alcohol abuse or drug addiction;
  9. subjects unlikely to be collaborative or to give reliable answers;
  10. pregnancy or lactation; female or childbearing potential without a clinical accepted contraceptive method;
  11. any severe pathology that can interfere with the treatment or the clinical or instrumental tests of the trial;
  12. intake of antiaggregant, anticoagulant, diuretic, beta-blocker, ACE- inhibitor, lithium, methotrexate, cimetidine, digoxin;
  13. contraindications to NSAIDs.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00565500

Locations
Italy
Ce.S.I., Center of Excellence on Aging, G. d'Annunzio University
Chieti, CH, Italy, 66100
Sponsors and Collaborators
University of Chieti
Pfizer
Investigators
Principal Investigator: Raffaele De Caterina, MD, PhD Institute of Cardiology, G. d'Annunzio University
  More Information

Publications:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on August 27, 2014