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The Standard Care Versus Celecoxib Outcome Trial

NCT00447759 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 7297

Last updated 2019-05-03

No results posted yet for this study

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

Interventions

DRUG

Celecoxib

200-400mg daily in divided doses

DRUG

Diclofenac

prescribed medication taken orally

Sponsors & Collaborators

  • University of Glasgow

    collaborator OTHER

  • University of Nottingham

    collaborator OTHER

  • University of Dundee

    lead OTHER

Principal Investigators

  • Thomas M MacDonald, MD MRCP FRCP · University of Dundee

  • Ian Ford, FRCP FRSE · University of Glasgow

  • Christopher J Hawkey, MRCP DM FRC · University of Nottingham

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2015-08-31
Completion
2015-08-31

Countries

  • Denmark
  • Netherlands
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00447759 on ClinicalTrials.gov