The Standard Care Versus Celecoxib Outcome Trial
Information source: University of Dundee
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Osteoarthritis; Rheumatoid Arthritis
Intervention: Celecoxib (Drug); non-selective Non steroidal anti inflammatory Drug (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: University of Dundee Official(s) and/or principal investigator(s):
Thomas M MacDonald, MD MRCP FRCP, Principal Investigator, Affiliation: University of Dundee
Ian Ford, FRCP FRSE, Principal Investigator, Affiliation: University of Glasgow
Christopher J Hawkey, MRCP DM FRC, Principal Investigator, Affiliation: University of Nottingham
Overall contact:
Thomas M MacDonald, MB MRCP FRCP, Phone: 01382 632852, Ext: 33854, Email: tom@memo.dundee.ac.uk
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 Anti-Inflammatory Drug (NSAID) therapy. Traditional NSAID's are associated with
significant morbidity and mortality from gastrointestinal toxicity. Cyclooxygenase 2
(Cox-2)selective agents are associated with reduced upper gastrointestinal
toxicity. Traditional NSAID's and Cox-2 inhibitors may also be associated with cardiovascular
and renal disorders. Data from both randomised and observational studies suggest that
celecoxib has similar or reduced cardiovascular toxicity when compared to traditional
NSAID's. However, the overall safety balance of a strategy of celecoxib therapy versus a
strategy of NSAID therapy is unknown. The European Medicines Evaluation Agency (EMEA) has
requested that studies of the cardiovascular safety of celecoxib be carried out within the
indicated population of Europe. This study addresses these issues by comparing the
cardiovascular safety of celecoxib therapy with traditional NSAID therapy in the setting of
the EU healthcare system
Clinical Details
Official title: Phase 4 Study A Large Streamline Safety Study Designed to Compare the Cardiovascular Safety od Celecoxib Versus Traditional Non-selective NSAID's
Study design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study
Primary outcome: To compare cardiovascular safety of celecoxib and traditional NSAIDs prescribed for the treatment of arthritis.
Secondary outcome: Is to demonstrate the superiority of celecoxib over traditional NSAIDs on ulcer-related upper gastrointestinal complications.
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 celecoxib or to 'usual-care' with their current non-selective NSAID therapy (with
or without cyto-protection with ulcer healing drug use in either celecoxib or 'usual-care'
limbs).
Trial Design
This trial utilises the Prospective Randomised Open Blinded End point (PROBE) design .
Patients with clinically diagnosed osteoarthritis (OA) or rheumatoid arthritis (RA) 60 years
of age or more who are free from established cardiovascular disease and who require chronic
NSAID therapy will be identified in the setting of primary care. These subjects will then
enter a two-week run-in period where they will take celecoxib 200mg once or twice daily.
Patients who successfully complete this run in period will be randomised to receive either
celecoxib or to continue their previous standard NSAID therapy. They will then be followed
up for an average of 2 years in the setting of the National Healthcare system. The study
will terminate when sufficient adjudicated events have accrued. A summary is shown in the
diagram below.
Eligibility
Minimum age: 60 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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.
Locations and Contacts
Thomas M MacDonald, MB MRCP FRCP, Phone: 01382 632852, Ext: 33854, Email: tom@memo.dundee.ac.uk
University of Dundee, dundee DD1 9SY, United Kingdom; Recruiting
Thomas M MacDonald, Principal Investigator
Additional Information
MEMO Website.
Related publications: MacDonald TM. A European's perspective of COX-2 drug safety. J Cardiovasc Pharmacol. 2006;47 Suppl 1:S92-7.
Starting date: June 2007
Ending date: December 2012
Last updated: September 4, 2009
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