Celecoxib, Ibuprofen and the Antiplatelet Effect of Aspirin

NCT00565500 | Completed Phase 4

• 2 other identifiers: 635-IFL-0508-017N49-98-71-900
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Heart Disease; Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• serum thromboxane (TX)B2

  1 week

Secondary Outcomes (1)

• 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

  1 week

Study Arms (3)

1

EXPERIMENTAL

Drug: celecoxib

2

EXPERIMENTAL

Drug: ibuprofen

3

PLACEBO COMPARATOR

Drug: placebo

Interventions

celecoxib DRUG

celecoxib capsules 200 mg bid for 1 week

1

ibuprofen DRUG

ibuprofen tablets 600 mg tid for 1 week

2

placebo DRUG

placebo capsules tid for 1 week

3

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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;
• history of active peptic ulceration, gastrointestinal bleeding, esophageal, gastric or duodenal ulcer;
• known hypersensitivity to COX-2 inhibitors, analgesics, antipyretics, sulfonamides or NSAIDs;
• treatment with any investigational drug within the previous 30 days;
• previous participation in this study;
• evidence of neoplasm or any other severe disease of any organ, including any psychiatric illness;
• clinically relevant deviations from the normal range in laboratory tests;
• recent history or suspicion of alcohol abuse or drug addiction;
• subjects unlikely to be collaborative or to give reliable answers;
• pregnancy or lactation; female or childbearing potential without a clinical accepted contraceptive method;
• any severe pathology that can interfere with the treatment or the clinical or instrumental tests of the trial;
• intake of antiaggregant, anticoagulant, diuretic, beta-blocker, ACE- inhibitor, lithium, methotrexate, cimetidine, digoxin;
• contraindications to NSAIDs.

Sponsors & Collaborators

• University of Chieti: lead
• Pfizer: collaborator

Study Sites (1)

Ce.S.I., Center of Excellence on Aging, G. d'Annunzio University

Chieti, CH, 66100, Italy

Location

Related Publications (4)

• Patrono C, Coller B, Dalen JE, FitzGerald GA, Fuster V, Gent M, Hirsh J, Roth G. Platelet-active drugs : the relationships among dose, effectiveness, and side effects. Chest. 2001 Jan;119(1 Suppl):39S-63S. doi: 10.1378/chest.119.1_suppl.39s. No abstract available.

  PMID: 11157642 BACKGROUND

• Patrignani P, Filabozzi P, Patrono C. Selective cumulative inhibition of platelet thromboxane production by low-dose aspirin in healthy subjects. J Clin Invest. 1982 Jun;69(6):1366-72. doi: 10.1172/jci110576.

  PMID: 7045161 BACKGROUND

• Catella-Lawson F, Reilly MP, Kapoor SC, Cucchiara AJ, DeMarco S, Tournier B, Vyas SN, FitzGerald GA. Cyclooxygenase inhibitors and the antiplatelet effects of aspirin. N Engl J Med. 2001 Dec 20;345(25):1809-17. doi: 10.1056/NEJMoa003199.

  PMID: 11752357 BACKGROUND

• FitzGerald GA, Patrono C. The coxibs, selective inhibitors of cyclooxygenase-2. N Engl J Med. 2001 Aug 9;345(6):433-42. doi: 10.1056/NEJM200108093450607. No abstract available.

  PMID: 11496855 BACKGROUND

MeSH Terms

Conditions

Myocardial Ischemia; Osteoarthritis

Interventions

Celecoxib; Ibuprofen

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids

Study Officials

• Raffaele De Caterina, MD, PhD

  Institute of Cardiology, G. d'Annunzio University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 29, 2007
• First Posted: November 30, 2007
• Study Start: April 1, 2003
• Study Completion: April 1, 2005
• Last Updated: November 30, 2007

Record last verified: 2007-11

Locations

IT (1)