The Standard Care Versus Celecoxib Outcome Trial (SCOTLSSS)

This study is currently recruiting participants.
Verified May 2012 by University of Dundee
Sponsor:
Collaborators:
University of Glasgow
University of Nottingham
Information provided by (Responsible Party):
Thomas M MacDonald, University of Dundee
ClinicalTrials.gov Identifier:
NCT00447759
First received: March 14, 2007
Last updated: May 17, 2012
Last verified: May 2012
  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

Resource links provided by NLM:


Further study details as provided by University of Dundee:

Primary Outcome Measures:
  • To compare cardiovascular safety of celecoxib and traditional NSAIDs prescribed for the treatment of arthritis. [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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:
  • Diclofenac
  • Ibuprofen
  • Naproxen
  • meloxicam

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
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00447759

Contacts
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

Locations
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         
Sponsors and Collaborators
University of Dundee
University of Glasgow
University of Nottingham
Investigators
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 April 16, 2014