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Post-authorization Safety Study of Etoricoxib and Other Anti-inflammatory Therapies in European Patients With Ankylosing Spondylitis (MK-0663-163)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01077843
First Posted: March 1, 2010
Last Update Posted: June 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
February 26, 2010
March 1, 2010
June 7, 2017
August 17, 2009
July 1, 2015   (Final data collection date for primary outcome measure)
  • Incidence rate of gastrointestinal ulcer, perforation or bleeding [ Time Frame: First incident event for a given patient through 31-December-2017 ]
  • Incidence rate of fatal or non-fatal acute myocardial infarction or unstable angina pectoris [ Time Frame: First incident event for a given patient through 31-December-2017 ]
  • Incidence rate of fatal or non-fatal ischemic stroke, or transient ischemic attack [ Time Frame: First incident event for a given patient through 31-December-2017 ]
  • Incidence rate of fatal or non-fatal hemorrhagic stroke [ Time Frame: First incident event for a given patient through 31-December-2017 ]
  • Incidence rate of deep venous thrombosis, pulmonary embolism, or peripheral arterial embolism or thrombosis [ Time Frame: First incident event for a given patient through 31-December-2017 ]
  • Incidence rate of acute renal impairment or failure [ Time Frame: First incident event for a given patient through 31-December-2017 ]
  • Incidence rate of hypertension [ Time Frame: First incident event for a given patient through 31-December-2017 ]
  • Incidence rate of congestive heart failure or left ventricular dysfunction [ Time Frame: First incident event for a given patient through 31-December-2017 ]
  • Incidence rate of sudden or unexplained death [ Time Frame: First incident event for a given patient through 31-December-2017 ]
  • Incidence rate of gastrointestinal ulcer, perforation or bleeding [ Time Frame: First incident event for a given patient through 31-December-2008 ]
  • Incidence rate of fatal and non-fatal acute myocardial infarction and unstable angina pectoris [ Time Frame: First incident event for a given patient through 31-December-2008 ]
  • Incidence rate of fatal and non-fatal ischemic stroke, or transient ischemic attack [ Time Frame: First incident event for a given patient through 31-December-2008 ]
  • Incidence rate of fatal and non-fatal hemorrhagic stroke [ Time Frame: First incident event for a given patient through 31-December-2008 ]
  • Incidence rate of deep venous thrombosis or pulmonary embolism [ Time Frame: First incident event for a given patient through 31-December-2008 ]
  • Incidence rate of acute renal impairment or failure [ Time Frame: First incident event for a given patient through 31-December-2008 ]
  • Incidence rate of hypertension [ Time Frame: First incident event for a given patient through 31-December-2008 ]
  • Incidence rate of congestive heart failure or left ventricular dysfunction [ Time Frame: First incident event for a given patient through 31-December-2008 ]
  • Incidence rate of sudden or unexplained death [ Time Frame: First incident event for a given patient through 31-December-2008 ]
Complete list of historical versions of study NCT01077843 on ClinicalTrials.gov Archive Site
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Post-authorization Safety Study of Etoricoxib and Other Anti-inflammatory Therapies in European Patients With Ankylosing Spondylitis (MK-0663-163)
A Nested Case-control Post-authorization Safety Study of Etoricoxib and Other Anti-inflammatory Therapies in a Cohort of Patients With Ankylosing Spondylitis (AS) in the UK, France and Germany

This study is a population-based cohort of patients with ankylosing spondylitis (AS) from general medical practices in the UK, France, and Germany with a nested case control component to assess associations between drug exposures of interest and clinical outcomes relevant to patients using cyclooxygenase-2 (COX-2) inhibitors / nonsteroidal anti-inflammatory drugs (NSAIDS).

The main objective of the study is to describe in European participants with AS: 1) the use of etoricoxib 2) characteristics of those who use etoricoxib. 3) the safety profile of etoricoxib and other anti-inflammatory therapies with respect to specific clinical outcomes of interest relative to non-use of these medications and relative to each other.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample
This study will use the combination of the General Practice Research Database (GPRD) in the UK, The Health Improvement Network (THIN) database in the UK, and the IMS Disease Analyzer Database (Disease Analyzer) in the UK, France and Germany.
Ankylosing Spondylitis
  • Drug: Etoricoxib
    Cox-2 inhibitor
    Other Name: ARCOXIA®
  • Drug: Other Cox-2 inhibitors
    Cox-2 inhibitor
  • Drug: Other Non-selective NSAIDs
    Non-selective NSAID
  • Other: No anti-inflammatory treatment
    No anti-inflammatory prescription
  • Exposure
    Ankylosing spondylitis patients currently exposed to anti-inflammatory treatments
    Interventions:
    • Drug: Etoricoxib
    • Drug: Other Cox-2 inhibitors
    • Drug: Other Non-selective NSAIDs
  • Non-exposure
    Ankylosing spondylitis patients not currently exposed to anti-inflammatory treatments
    Intervention: Other: No anti-inflammatory treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
27381
July 1, 2015
July 1, 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • A recorded Ankylosing Spondylitis diagnosis in the database
  • A recorded AS diagnosis following the applicable "acceptable data quality" date for the database that contains the patient's records
  • At least 6 months of registered medical records in the database after the applicable "acceptable data quality" date as described above, and prior to the recorded AS diagnosis
  • Complete information on gender and birth year
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01077843
0663-163
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
June 2017