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Etoricoxib Prescribing Patterns and Adverse Events of Interest in Primary Care in the United Kingdom (MK-0663-162 AM1)

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.
 
ClinicalTrials.gov Identifier: NCT01685424
Recruitment Status : Completed
First Posted : September 14, 2012
Last Update Posted : February 18, 2022
Sponsor:
Information provided by (Responsible Party):
Organon and Co

Tracking Information
First Submitted Date August 23, 2012
First Posted Date September 14, 2012
Last Update Posted Date February 18, 2022
Actual Study Start Date June 30, 2006
Actual Primary Completion Date March 1, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 11, 2012)
  • Dose of Initial Etoricoxib Prescription [ Time Frame: At first prescription (during a time period up to 13.75 years) ]
  • Duration of Initial Etoricoxib Prescription [ Time Frame: At first prescription (during a time period up to 13.75 years) ]
  • Participant's Baseline Characteristics (Demographics and Medical) [ Time Frame: At first prescription (during a time period up to 13.75 years) ]
  • Incidence of Adverse Events of Special Interest Among Etoricoxib Users [ Time Frame: During a time period up to 13.75 years ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: September 11, 2012)
"Off-label" use of Etoricoxib [ Time Frame: At first prescription (during a time period up to 13.75 years) ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Etoricoxib Prescribing Patterns and Adverse Events of Interest in Primary Care in the United Kingdom (MK-0663-162 AM1)
Official Title Etoricoxib Prescribing Patterns and Adverse Events of Interest During Etoricoxib Treatment in UK Primary Care; an Updated Analysis
Brief Summary This postmarketing study was conducted to describe prescribing patterns for etoricoxib (ARCOXIA®) in General Practice and describe the incidence of selected adverse events recorded in the United Kingdom (UK) Medicines and Health Care Products Regulatory Agency (MHRA) General Practice Research Database (GPRD).
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population All participants in the MHRA's Full Feature GPRD (FF-GPRD) who have at least one electronic outpatient prescription record for etoricoxib issued by a General Practitioner during the period (April 1, 2002 to December 31, 2015) at the date of query execution against the FF-GPRD data warehouse.
Condition
  • Osteoarthritis
  • Rheumatoid Arthritis
  • Ankylosing Spondylitis
  • Gout
  • Arthritis
Intervention Drug: Etoricoxib
As per routine clinical practice in the United Kingdom
Other Name: ARCOXIA®)
Study Groups/Cohorts
  • Etoricoxib Prescription (Period 1)
    First Etoricoxib Prescription, Apr. 1, 2002 to Feb. 17, 2005
    Intervention: Drug: Etoricoxib
  • Etoricoxib Prescription (Period 2)
    First Etoricoxib Prescription, Feb. 18, 2005 to Dec. 31, 2015
    Intervention: Drug: Etoricoxib
  • Repeat Etoricoxib Prescription
    One prescription during the Period 1 and, at least, one etoricoxib prescription during Period 2.
    Intervention: Drug: Etoricoxib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 2, 2017)
79189
Original Estimated Enrollment
 (submitted: September 11, 2012)
30000
Actual Study Completion Date March 1, 2015
Actual Primary Completion Date March 1, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • All patients in the MHRA's Full Feature GPRD (FF-GPRD) who have at least one electronic outpatient prescription record for etoricoxib issued by a General Practitioner during the period (April 1, 2002 to December 31, 2015) at the date of query execution against the FF-GPRD data warehouse.

Exclusion Criteria:

  • Not registered in a GPRD-contributing practice that had continuously

collected data deemed to be 'up-to-standard' for research purposes from 1 April 2002 through to 31 December 2015.

  • Never registered as a permanent patient of a General Practitioner in the practice
  • Registration details were not acceptable (i.e. incomplete data or logically implausible dates)
  • Not registered with a General Practitioner for at least 365 days before the date that the patient's first etoricoxib prescription was recorded in the GPRD
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number NCT01685424
Other Study ID Numbers 0663-162
7013.021 ( Other Identifier: Study Identification Number )
EMEA/H/A - 31/632 ( Other Identifier: Regulatory identifier )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party Organon and Co
Original Responsible Party Merck Sharp & Dohme LLC
Current Study Sponsor Organon and Co
Original Study Sponsor Merck Sharp & Dohme LLC
Collaborators Not Provided
Investigators Not Provided
PRS Account Organon and Co
Verification Date February 2022