The Standard Care Versus Celecoxib Outcome Trial (SCOTLSSS)

This study is ongoing, but not recruiting participants.
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: April 29, 2014
Last verified: April 2014
  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: February 2015
Estimated Primary Completion Date: February 2015 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Denmark
University of Southern Denmark
Odense, Denmark, 5000
Netherlands
Julius Clinical Research
Zeist, Netherlands, 3703 CD Zeist
United Kingdom
University of Aberdeen
Aberdeen, United Kingdom, AB25 2ZN
University of Birmingham
Birmingham, United Kingdom, B15 2TT
University of Dundee
Dundee, United Kingdom, DD1 9SY
University of Edinburgh
Edinburgh, United Kingdom, EH4 2XU
University of Glasgow
Glasgow, United Kingdom, G11 6NT
NHS Highlands
Inverness, United Kingdom, IV2 3JH
Kings College London
London, United Kingdom, SE1 3QD
University of Nottingham
Nottingham, United Kingdom, NG7 2UH
University of Oxford
Oxford, United Kingdom, OX1 2ET
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: April 29, 2014
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
Anti-Inflammatory Agents, Non-Steroidal
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Therapeutic Uses
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 18, 2014