Celecoxib, Ibuprofen and the Antiplatelet Effect of Aspirin

• Status: Completed
• Trial end date: 2005-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Chieti
• Collaborator: Pfizer
• Treatments: Aspirin; Celecoxib; Ibuprofen

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.