The Standard Care Versus Celecoxib Outcome Trial

NCT00447759 | Completed Phase 4 DMC

• 1 other identifier: SCOT Trial
• Study Type: interventional
• Target: 7,297
• Locations: 3 countries
• Sites: 10

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.

Conditions

Osteoarthritis; Rheumatoid Arthritis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• compare cardiovascular safety of celecoxib and traditional NSAIDs prescribed for the treatment of arthritis.

  4 years

Secondary Outcomes (1)

• demonstrate the superiority of celecoxib over traditional NSAIDs on ulcer-related upper gastrointestinal complications.

  4 years

Study Arms (2)

Celecoxib

EXPERIMENTAL

Celecoxib. Celebrex 200-400mg daily in divided doses

Drug: Celecoxib

Diclofenac

ACTIVE COMPARATOR

continue usual nsNSAID

Drug: Diclofenac

Interventions

Celecoxib DRUG

200-400mg daily in divided doses

Also known as: Celebrex

Celecoxib

Diclofenac DRUG

prescribed medication taken orally

Also known as: Ibuprofen, Naproxen, meloxicam, other presribed sNSAIDs

Diclofenac

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Dundee: lead
• University of Glasgow: collaborator
• University of Nottingham: collaborator

Study Sites (10)

University of Southern Denmark

Odense, 5000, Denmark

Location

Julius Clinical Research

Zeist, 3703 CD Zeist, Netherlands

Location

University of Aberdeen

Aberdeen, AB25 2ZN, United Kingdom

Location

University of Birmingham

Birmingham, B15 2TT, United Kingdom

Location

University of Dundee

Dundee, DD1 9SY, United Kingdom

Location

University of Edinburgh

Edinburgh, EH4 2XU, United Kingdom

Location

University of Glasgow

Glasgow, G11 6NT, United Kingdom

Location

NHS Highlands

Inverness, IV2 3JH, United Kingdom

Location

University of Nottingham

Nottingham, NG7 2UH, United Kingdom

Location

University of Oxford

Oxford, OX1 2ET, United Kingdom

Location

Related Publications (4)

• MacDonald TM. A European's perspective of COX-2 drug safety. J Cardiovasc Pharmacol. 2006;47 Suppl 1:S92-7. doi: 10.1097/00005344-200605001-00017.

  PMID: 16785838 BACKGROUND

• MacDonald TM, Hawkey CJ, Ford I, McMurray JJV, Scheiman JM, Hallas J, Findlay E, Grobbee DE, Hobbs FDR, Ralston SH, Reid DM, Walters MR, Webster J, Ruschitzka F, Ritchie LD, Perez-Gutthann S, Connolly E, Greenlaw N, Wilson A, Wei L, Mackenzie IS. Randomized trial of switching from prescribed non-selective non-steroidal anti-inflammatory drugs to prescribed celecoxib: the Standard care vs. Celecoxib Outcome Trial (SCOT). Eur Heart J. 2017 Jun 14;38(23):1843-1850. doi: 10.1093/eurheartj/ehw387.

  PMID: 27705888 DERIVED

• Jennings CG, MacDonald TM, Wei L, Brown MJ, McConnachie L, Mackenzie IS. Does offering an incentive payment improve recruitment to clinical trials and increase the proportion of socially deprived and elderly participants? Trials. 2015 Mar 7;16:80. doi: 10.1186/s13063-015-0582-8.

  PMID: 25888477 DERIVED

• Macdonald TM, Mackenzie IS, Wei L, Hawkey CJ, Ford I; SCOT study group collaborators. Methodology of a large prospective, randomised, open, blinded endpoint streamlined safety study of celecoxib versus traditional non-steroidal anti-inflammatory drugs in patients with osteoarthritis or rheumatoid arthritis: protocol of the standard care versus celecoxib outcome trial (SCOT). BMJ Open. 2013 Jan 29;3(1):e002295. doi: 10.1136/bmjopen-2012-002295.

  PMID: 23364320 DERIVED

MeSH Terms

Conditions

Osteoarthritis; Arthritis, Rheumatoid; Arthritis

Interventions

Celecoxib; Diclofenac; Ibuprofen; Naproxen; Meloxicam

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Phenylpropionates; Naphthaleneacetic Acids; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Thiazines; Thiazoles

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: NSAID
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective Randomised Open Blinded-Endpoint Study (PROBE)

Study Record Dates

• First Submitted: March 14, 2007
• First Posted: March 15, 2007
• Study Start: June 1, 2007
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: May 3, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 28/08/2015
• Access Criteria: Open Access Journals

Locations

DK (1); GB (8); NL (1)