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

March 14, 2007
April 29, 2014
June 2007
February 2015   (final data collection date for primary outcome measure)
To compare cardiovascular safety of celecoxib and traditional NSAIDs prescribed for the treatment of arthritis. [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
To compare cardiovascular safety of celecoxib and traditional NSAIDs prescribed for the treatment of arthritis.
Complete list of historical versions of study NCT00447759 on ClinicalTrials.gov Archive Site
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 ]
Is to demonstrate the superiority of celecoxib over traditional NSAIDs on ulcer-related upper gastrointestinal complications.
Not Provided
Not Provided
 
The Standard Care Versus Celecoxib Outcome Trial
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

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Osteoarthritis
  • Rheumatoid Arthritis
  • Drug: Celecoxib
    200-400mg daily in divided doses
    Other Name: Celebrex
  • Drug: non-selective Non steroidal anti inflammatory Drug
    taken orally
    Other Names:
    • Diclofenac
    • Ibuprofen
    • Naproxen
    • meloxicam
  • Experimental: Celecoxib
    Drug
    Intervention: Drug: Celecoxib
  • Active Comparator: NSAID
    Drug
    Intervention: Drug: non-selective Non steroidal anti inflammatory Drug
MacDonald TM. A European's perspective of COX-2 drug safety. J Cardiovasc Pharmacol. 2006;47 Suppl 1:S92-7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
16000
February 2015
February 2015   (final data collection date for primary outcome measure)

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.
Both
60 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Netherlands,   United Kingdom,   Denmark
 
NCT00447759
SCOT Trial
Yes
Thomas M MacDonald, University of Dundee
University of Dundee
  • University of Glasgow
  • University of Nottingham
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
University of Dundee
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP