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The Standard Care Versus Celecoxib Outcome Trial (SCOTLSSS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00447759
Recruitment Status : Completed
First Posted : March 15, 2007
Last Update Posted : May 3, 2019
University of Glasgow
University of Nottingham
Information provided by (Responsible Party):
University of Dundee

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 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.

As of May 2013, 7300 patients had been randomised, and had accrued an average 4.2 years of follow up by the end of May 2014.

Condition or disease Intervention/treatment Phase
Osteoarthritis Rheumatoid Arthritis Drug: Celecoxib Drug: Diclofenac Phase 4

Detailed Description:


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. Patients 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 4.2 years in the setting of the local National Healthcare system. The study will terminate when 277 adjudicated cardiovascular events have accrued. A summary is shown in the diagram below.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7297 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective Randomised Open Blinded-Endpoint Study (PROBE)
Masking: None (Open Label)
Masking Description: NSAID
Primary Purpose: Treatment
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 Start Date : June 2007
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arthritis

Arm Intervention/treatment
Experimental: Celecoxib
Celecoxib. Celebrex 200-400mg daily in divided doses
Drug: Celecoxib
200-400mg daily in divided doses
Other Name: Celebrex

Active Comparator: Diclofenac
continue usual nsNSAID
Drug: Diclofenac
prescribed medication taken orally
Other Names:
  • Ibuprofen
  • Naproxen
  • meloxicam
  • other presribed sNSAIDs

Primary Outcome Measures :
  1. compare cardiovascular safety of celecoxib and traditional NSAIDs prescribed for the treatment of arthritis. [ Time Frame: 4 years ]

Secondary Outcome Measures :
  1. demonstrate the superiority of celecoxib over traditional NSAIDs on ulcer-related upper gastrointestinal complications. [ Time Frame: 4 years ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00447759

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University of Southern Denmark
Odense, Denmark, 5000
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
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
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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
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University of Dundee Identifier: NCT00447759    
Other Study ID Numbers: SCOT Trial
First Posted: March 15, 2007    Key Record Dates
Last Update Posted: May 3, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data released on application to steering committee
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: 28/08/2015
Access Criteria: Open Access Journals
Keywords provided by University of Dundee:
Rheumatoid Arthritis
Safety study
Cardiovascular safety
Clinical trial
PROBE design
University of Dundee
Medicines Monitoring Unit
Professor Tom MacDonald
Additional relevant MeSH terms:
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Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase 2 Inhibitors
Gout Suppressants