The Standard Care Versus Celecoxib Outcome Trial (SCOTLSSS)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Osteoarthritis Rheumatoid Arthritis |
Drug: Celecoxib Drug: non-selective Non steroidal anti inflammatory Drug |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Phase 4 Study A Large Streamline Safety Study Designed to Compare the Cardiovascular Safety od Celecoxib Versus Traditional Non-selective NSAID's |
- To compare cardiovascular safety of celecoxib and traditional NSAIDs prescribed for the treatment of arthritis. [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
- Is to demonstrate the superiority of celecoxib over traditional NSAIDs on ulcer-related upper gastrointestinal complications. [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 16000 |
| Study Start Date: | June 2007 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Celecoxib
Drug
|
Drug: Celecoxib
200-400mg daily in divided doses
Other Name: Celebrex
|
|
Active Comparator: NSAID
Drug
|
Drug: non-selective Non steroidal anti inflammatory Drug
taken orally
Other Names:
|
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| Ages Eligible for Study: | 60 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| Contact: Thomas M MacDonald, MB MRCP FRCP | 01382 632852 ext 33854 | tom@memo.dundee.ac.uk |
| Contact: Adam Wilson | +44 (0)1382 640306 | adam@memo.dundee.ac.uk |
| Denmark | |
| University of Southern Denmark | Recruiting |
| Odense, Denmark, 5000 | |
| Contact: Vivi Toft Lie +45 6550 4162 | |
| Principal Investigator: Jesper Hallas, Prof | |
| Netherlands | |
| Julius Clinical Research | Recruiting |
| Zeist, Netherlands, 3703 CD Zeist | |
| Contact: Hans Hoogeveen +31 30 656 9912 | |
| Principal Investigator: Rick Grobee, Prof | |
| United Kingdom | |
| University of Aberdeen | Recruiting |
| Aberdeen, United Kingdom, AB25 2ZN | |
| Contact: Jacqueline Furnace 01224 554499/559163 | |
| Principal Investigator: John Webster, Prof | |
| University of Birmingham | Recruiting |
| Birmingham, United Kingdom, B15 2TT | |
| Contact: Rachel Iles 0121 414 2691 | |
| Principal Investigator: Richard Hobbs, Prof | |
| University of Dundee | Recruiting |
| Dundee, United Kingdom, DD1 9SY | |
| Principal Investigator: Thomas M MacDonald | |
| University of Edinburgh | Recruiting |
| Edinburgh, United Kingdom, EH4 2XU | |
| Contact: Janet Thomson 0131 5373856 | |
| Contact: Julia Boyd 0131 5373856 | |
| Principal Investigator: Stuart Ralston, Prof | |
| University of Glasgow | Recruiting |
| Glasgow, United Kingdom, G11 6NT | |
| Contact: Linda Wilson +44 (0)141 232 9515 | |
| Principal Investigator: Matthew Walters, Prof | |
| NHS Highlands | Recruiting |
| Inverness, United Kingdom, IV2 3JH | |
| Contact: Avril Donaldson +44 (0)1463 255820 | |
| Principal Investigator: John Harvie | |
| Kings College London | Recruiting |
| London, United Kingdom, SE1 3QD | |
| Contact: Christina Currie +44 (0)207 848 6643 | |
| Contact: Alicia King +44 (0)207 848 6643 | |
| Principal Investigator: Brendan Delaney, Prof | |
| University of Nottingham | Recruiting |
| Nottingham, United Kingdom, NG7 2UH | |
| Contact: Jennifer Dumbleton 0115 823 1053 | |
| Principal Investigator: Chris Hawkey, Prof | |
| University of Oxford | Recruiting |
| Oxford, United Kingdom, OX1 2ET | |
| Contact: Ben Thomson 01865 289296 | |
| Principal Investigator: Richard Hobbs, Prof | |
| Principal Investigator: | Thomas M MacDonald, MD MRCP FRCP | University of Dundee |
| Principal Investigator: | Ian Ford, FRCP FRSE | University of Glasgow |
| Principal Investigator: | Christopher J Hawkey, MRCP DM FRC | University of Nottingham |
More Information
Additional Information:
Publications:
| Responsible Party: | Thomas M MacDonald, Professor, University of Dundee |
| ClinicalTrials.gov Identifier: | NCT00447759 History of Changes |
| Other Study ID Numbers: | SCOT Trial |
| Study First Received: | March 14, 2007 |
| Last Updated: | May 17, 2012 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency United Kingdom: Research Ethics Committee United Kingdom: National Health Service |
Keywords provided by University of Dundee:
|
Celecoxib Celebrex Ibuprofen Diclofenac NSAID Osteoarthritis Rheumatoid Arthritis Arthritis |
Safety study Cardiovascular safety Clinical trial PROBE design University of Dundee Medicines Monitoring Unit MEMO Professor Tom MacDonald |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Rheumatoid Osteoarthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Celecoxib Anti-Inflammatory Agents Diclofenac Ibuprofen Anti-Inflammatory Agents, Non-Steroidal |
Therapeutic Uses Pharmacologic Actions Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Central Nervous System Agents Cyclooxygenase 2 Inhibitors |
ClinicalTrials.gov processed this record on May 19, 2013