The Standard Care versus Celecoxib Outcome Trial (SCOT) is a large streamlined safety study designed to compare the cardiovascular safety of celecoxib versus traditional non-selective Non Steroidal Anti-Inflammatory Drug (NSAID) therapy when used to treat pain and inflammation in osteoarthritis or rheumatoid arthritis patients who are free from ischaemic heart disease, cerebrovascular disease, peripheral arterial disease, and moderate or severe heart failure. MedDRA version: 13.1 Level: LLT Cla
Conditions
Interventions
Trade Name: Celebrex
Pharmaceutical Form: Tablet
Trade Name: Patients' existing non-steroidal anti-inflammatory drug (NSAID) at approved doses
Pharmaceutical Form: Tablet
Sponsors
University of Dundee
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 60 or over. 2. Male & Female subjects. 3. Chronic NSAID use (= 90 days or at least 3 filled prescriptions in the last year). 4. Subjects who in the opinion of the recruiting physician have a licensed indication for chronic non-selective NSAID or celecoxib therapy (osteoarthritis or rheumatoid arthritis). 5. Subjects, who in the opinion of the study site investigator, are eligible for treatment (with reference to the summary of product characteristics) with either celecoxib or an alternative traditional non-selective NSAID. In particular these subjects must be free from established cardiovascular disease (established IHD, cerebrovascular disease and peripheral arterial disease). 6. Subjects who are willing to give permission for their paper and electronic medical records and prescribing data to be accessed and abstracted by trial investigators. 7. Subjects who are willing to be contacted and interviewed by trial investigators, should the need arise for adverse event assessment etc. 8. For the avoidance of doubt, there are no other specific co-morbidities, or concurrent drug therapies (including aspirin) that are contraindicated. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Established cardiovascular disease including ischaemic heart disease such as myocardial infarction, angina or acute coronary syndrome, cerebrovascular disease such as a cerebrovascular accident or transient ischaemic attack, established peripheral vascular disease and moderate or severe heart failure. 2. Subject currently taking a COX2 Selective NSAID (celecoxib, etoricoxib and lumiracoxib); or having received one of the therapies within 90 days of screening. 3. Presence of a life-threatening co-morbidity (investigator opinion). 4. Presence of clinically important renal or hepatic disease (investigator opinion). 5. Subjects whose behaviour or life-style that would render them less likely to comply with study medication (i.e., alcoholism, substance misuse, debilitating psychiatric conditions or inability to provide informed consent). 6. Subjects with known or suspected allergy to study drugs including celecoxib or current NSAIDs. 7. Subjects with known hypersensitivity to sulphonamide antibiotics. 8. Subjects with active peptic ulceration or gastrointestinal (GI) bleeding. 9. Subjects scheduled to have arthritis surgery likely to modify their need for pain relief within the next year. 10. Subjects currently participating in another clinical trial or who have been in a trial in the previous three months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to compare the cardiovascular safety of celecoxib and traditional NSAIDs prescribed for the treatment of arthritis. ;Secondary Objective: The first ranked secondary objective of the study is to demonstrate the superiority of celecoxib over traditional NSAIDs on ulcer-related upper gastrointestinal complications.;Primary end point(s): The primary end point of the study will be the first occurrence of hospitalisation or death for the Anti-Platelet Trialists’ Collaboration (APTC) cardiovascular end-point of non-fatal myocardial infarction, non-fatal stroke or cardiovascular death. | — |
Countries
Denmark, Netherlands, United Kingdom
Outcome results
None listed