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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	21 February 2022
Main ID:	NCT01077843
Date of registration:	26/02/2010
Prospective Registration:	No
Primary sponsor:	Organon and Co
Public title:	Post-authorization Safety Study of Etoricoxib and Other Anti-inflammatory Therapies in European Patients With Ankylosing Spondylitis (MK-0663-163)
Scientific title:	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
Date of first enrolment:	August 17, 2009
Target sample size:	27381
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT01077843
Study type:	Observational
Study design:
Phase:

Countries of recruitment

Contacts

Name:	Medical Monitor
Address:
Telephone:
Email:
Affiliation:	Merck Sharp & Dohme Corp.

Key inclusion & exclusion criteria

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

Age minimum: N/A
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Ankylosing Spondylitis

Intervention(s)

Drug: Other Non-selective NSAIDs

Other: No anti-inflammatory treatment

Drug: Etoricoxib

Drug: Other Cox-2 inhibitors

Primary Outcome(s)

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 gastrointestinal ulcer, perforation or bleeding [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 acute renal impairment or failure [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 fatal or non-fatal hemorrhagic stroke [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 sudden or unexplained death [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]

Secondary Outcome(s)

Secondary ID(s)

0663-163

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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