The Standard Care Versus Celecoxib Outcome Trial (SCOTLSSS)

May 1, 2019 updated by: University of Dundee

Phase 4 Study A Large Streamline Safety Study Designed to Compare the Cardiovascular Safety od Celecoxib Versus Traditional Non-selective NSAID's

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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. 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.

Study Type

Interventional

Enrollment (Actual)

7297

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Odense, Denmark, 5000
        • University of Southern Denmark
  • Netherlands
      • Zeist, Netherlands, 3703 CD Zeist
        • Julius Clinical Research
  • United Kingdom
      • Aberdeen, United Kingdom, AB25 2ZN
        • University of Aberdeen
      • Birmingham, United Kingdom, B15 2TT
        • University of Birmingham
      • Dundee, United Kingdom, DD1 9SY
        • University of Dundee
      • Edinburgh, United Kingdom, EH4 2XU
        • University of Edinburgh
      • Glasgow, United Kingdom, G11 6NT
        • University of Glasgow
      • Inverness, United Kingdom, IV2 3JH
        • NHS Highlands
      • Nottingham, United Kingdom, NG7 2UH
        • University of Nottingham
      • Oxford, United Kingdom, OX1 2ET
        • University of Oxford

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Celecoxib
Celecoxib. Celebrex 200-400mg daily in divided doses
Drug: Celecoxib
200-400mg daily in divided doses
Other Names:
  • Celebrex
Active Comparator: Diclofenac
continue usual nsNSAID
Drug: Diclofenac
prescribed medication taken orally
Other Names:
  • Ibuprofen
  • meloxicam
  • Naproxen
  • other presribed sNSAIDs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
compare cardiovascular safety of celecoxib and traditional NSAIDs prescribed for the treatment of arthritis.
Time Frame: 4 years
4 years

Secondary Outcome Measures

Outcome Measure
Time Frame
demonstrate the superiority of celecoxib over traditional NSAIDs on ulcer-related upper gastrointestinal complications.
Time Frame: 4 years
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Dundee

Collaborators

University of Nottingham
University of Glasgow

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

March 14, 2007

First Submitted That Met QC Criteria

March 14, 2007

First Posted (Estimate)

March 15, 2007

Study Record Updates

Last Update Posted (Actual)

May 3, 2019

Last Update Submitted That Met QC Criteria

May 1, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCOT Trial

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data released on application to steering committee

IPD Sharing Time Frame

28/08/2015

IPD Sharing Access Criteria

Open Access Journals

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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