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

November 29, 2007
November 29, 2007
April 2003
Not Provided
serum thromboxane (TX)B2 [ Time Frame: 1 week ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
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 ]
Same as current
Not Provided
Not Provided
 
Celecoxib, Ibuprofen and the Antiplatelet Effect of Aspirin
A Placebo-Controlled, Double-Blind, Randomized Study of the Potential Interaction Between Aspirin and Ibuprofen or Celecoxib.

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
  • Ischemic Heart Disease
  • Osteoarthritis
  • Drug: celecoxib
    celecoxib capsules 200 mg bid for 1 week
    Other Name: celecoxib
  • Drug: ibuprofen
    ibuprofen tablets 600 mg tid for 1 week
    Other Name: ibuprofen
  • Drug: placebo
    placebo capsules tid for 1 week
    Other Name: placebo
  • Experimental: 1
    Intervention: Drug: celecoxib
  • Experimental: 2
    Intervention: Drug: ibuprofen
  • Placebo Comparator: 3
    Intervention: Drug: placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
April 2005
Not Provided

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.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00565500
635-IFL-0508-017, N49-98-71-900
No
Raffaele De Caterina, MD, PhD, G. d'Annunzio University - Chieti
University of Chieti
Pfizer
Principal Investigator: Raffaele De Caterina, MD, PhD Institute of Cardiology, G. d'Annunzio University
G. d'Annunzio University
November 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP