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Trial record 1 of 1 for:    NCT00565500
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Celecoxib, Ibuprofen and the Antiplatelet Effect of Aspirin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00565500
Recruitment Status : Completed
First Posted : November 30, 2007
Last Update Posted : November 30, 2007
Information provided by:
G. d'Annunzio University

Tracking Information
First Submitted Date  ICMJE November 29, 2007
First Posted Date  ICMJE November 30, 2007
Last Update Posted Date November 30, 2007
Study Start Date  ICMJE April 2003
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: November 29, 2007)
serum thromboxane (TX)B2 [ Time Frame: 1 week ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 29, 2007)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Celecoxib, Ibuprofen and the Antiplatelet Effect of Aspirin
Official Title  ICMJE A Placebo-Controlled, Double-Blind, Randomized Study of the Potential Interaction Between Aspirin and Ibuprofen or Celecoxib.
Brief Summary 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE
  • Ischemic Heart Disease
  • Osteoarthritis
Intervention  ICMJE
  • Drug: celecoxib
    celecoxib capsules 200 mg bid for 1 week
  • Drug: ibuprofen
    ibuprofen tablets 600 mg tid for 1 week
  • Drug: placebo
    placebo capsules tid for 1 week
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Drug: celecoxib
  • Experimental: 2
    Intervention: Drug: ibuprofen
  • Placebo Comparator: 3
    Intervention: Drug: placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 29, 2007)
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00565500
Other Study ID Numbers  ICMJE 635-IFL-0508-017
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Raffaele De Caterina, MD, PhD, G. d'Annunzio University - Chieti
Study Sponsor  ICMJE University of Chieti
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator: Raffaele De Caterina, MD, PhD Institute of Cardiology, G. d'Annunzio University
PRS Account G. d'Annunzio University
Verification Date November 2007

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