Status:
COMPLETED
The Standard Care Versus Celecoxib Outcome Trial
Lead Sponsor:
University of Dundee
Collaborating Sponsors:
University of Glasgow
University of Nottingham
Conditions:
Osteoarthritis
Rheumatoid Arthritis
Eligibility:
All Genders
60+ years
Phase:
PHASE4
Brief Summary
The Standard Care versus Celecoxib Outcome Trial (SCOT) is a large streamline safety study designed to compare the cardiovascular safety of celecoxib versus traditional non-selective Non Steroidal Ant...
Detailed Description
Aims The present proposal seeks to compare the cardiovascular and gastrointestinal safety and effectiveness of a strategy of initial randomisation to treatment with the selective COX-2 inhibitor cele...
Eligibility Criteria
Inclusion
- Subjects 60 years or over Male \& Female
- Chronic NSAIDs use for 90 days or more in a 12 month period
- Subjects who have a licensed indication for chronic non-selective NSAID or Celecoxib.
- Eligible for treatment with either Celecoxib or alternative traditional non-selective NSAID.
- Subjects who are willing to consent to their paper and electronic medical records and prescribing data to be accessed.
- Subjects who are willing to be contacted and interviewed by trial investigators.
Exclusion
- Established cardiovascular disease including ischaemic heart disease, Myocardial Infarction, angina or acute coronary syndrome, cerebrovascular disease or cerebrovascular accident or transient ischaemic attack, established peripheral vascular disease and moderate to severe heart failure.
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
7297 Patients enrolled
Trial Details
Trial ID
NCT00447759
Start Date
June 1 2007
End Date
August 1 2015
Last Update
May 3 2019
Active Locations (10)
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1
University of Southern Denmark
Odense, Denmark, 5000
2
Julius Clinical Research
Zeist, Netherlands, 3703 CD Zeist
3
University of Aberdeen
Aberdeen, United Kingdom, AB25 2ZN
4
University of Birmingham
Birmingham, United Kingdom, B15 2TT