The Standard Care Versus Celecoxib Outcome Trial - Full Text View

Sponsor:	University of Dundee
Collaborators:	University of Glasgow University of Nottingham
Information provided by:	University of Dundee
ClinicalTrials.gov Identifier:	NCT00447759

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 IV

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:

MedlinePlus related topics: Osteoarthritis Rheumatoid Arthritis

Drug Information available for: Diclofenac Ibuprofen Naproxen Meloxicam Celecoxib

U.S. FDA Resources

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:	December 2012
Estimated Primary Completion Date:	June 2012 (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

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

Contacts

Contact: Thomas M MacDonald, MB MRCP FRCP

01382 632852 ext 33854

tom@memo.dundee.ac.uk

Locations

United Kingdom
University of Dundee	Recruiting
Dundee, United Kingdom, DD1 9SY
Principal Investigator: Thomas M MacDonald

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:

MEMO Website. This link exits the ClinicalTrials.gov site

Publications:

MacDonald TM. A European's perspective of COX-2 drug safety. J Cardiovasc Pharmacol. 2006;47 Suppl 1:S92-7.

Responsible Party:	Professor Tom MacDonald, University of Dundee
ClinicalTrials.gov Identifier:	NCT00447759 History of Changes
Other Study ID Numbers:	SCOT Trial
Study First Received:	March 14, 2007
Last Updated:	July 21, 2010
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency; United Kingdom: Research Ethics Committee; United Kingdom: National Health Service

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
Therapeutic Uses

Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 09, 2012