Clinical trial NCT01572675: A Study of the Patterns of Use of Etoricoxib in France (MK-0663-148)
Official title: Pharmacoepidemiological Study on the Use of Arcoxia® Under Actual Conditions of Use in France
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis
Keywords: Pharmacoepidemiological
Longitudinal
Observational
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2012-04-06
Enrollment: 547
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants spontaneously consulting a general practitioner or rheumatologist and having agreed to take part in this study.

Brief summary: This postmarketing study will examine the use of etoricoxib (Arcoxia®) in routine clinical practice in France as well as the use of celecoxib (Celebrex®).


Eligibility criteria: Inclusion Criteria:

* Treatment-naive, discontinued the previous treatment course of etoricoxib or celecoxib at least 3 months previously or currently receiving continuous treatment with oral etoricoxib or celecoxib
* Consent to take part in the study
* Included in his/her physician's client base for at least 1 year

Exclusion Criteria:

* Unable to receive follow-up over a year
* Included in an interventional trial

Primary outcomes:
measure: Number of Participants Demonstrating Proper Use of Arcoxia® and Celebrex®
timeFrame: Up to 12 months
measure: Reasons for Misuse of Arcoxia® and Celebrex®
timeFrame: Up to 12 months
measure: Indications for Which Arcoxia® and Celebrex® Were Prescribed
timeFrame: At study entry
measure: Dosage of Arcoxia® and Celebrex® at Initiation
timeFrame: At study entry
measure: Mean Dosage of Arcoxia® and Celebrex® During Treatment
timeFrame: Up to 12 months
measure: Number of Participants Requiring Dose Modification of Arcoxia® and Celebrex®
timeFrame: Up to 12 months
measure: Duration of Prescription for Arcoxia® and Celebrex® at Enrollment
timeFrame: Up to 3 months prior to study entry
measure: Total Duration of Treatment With Arcoxia® and Celebrex®
timeFrame: Up to 12 months
measure: Maximum Dosage Prescribed During Treatment With Arcoxia® and Celebrex®
timeFrame: Up to 12 months
measure: Reasons for Discontinuation of Treatment With Arcoxia® and Celebrex®
timeFrame: Up to 12 months
measure: Type of Arcoxia® and Celebrex® Use
timeFrame: Up to 12 months
measure: Type of Arcoxia® and Celebrex® Use According to Duration of Treatment
timeFrame: Up to 12 months
Secondary outcomes:
measure: Mean Body Mass Index (BMI) at Study Entry in Participants Treated With Arcoxia® and Celebrex®
timeFrame: At study entry (baseline)
measure: Mean Systolic and Diastolic Blood Pressure (BP) at Study Entry in Participants Treated With Arcoxia® and Celebrex®
timeFrame: At study entry (baseline)
measure: Blood Pressure at Study Entry in Participants Treated With Arcoxia® and Celebrex®
timeFrame: At study entry (baseline)
measure: Medical History of Participants Treated With Arcoxia® and Celebrex®
timeFrame: At study entry
measure: Co-morbidities in Participants Treated With Arcoxia® and Celebrex®
timeFrame: At study entry
measure: Significant Past Treatments Prior to Initiating Treatment With Arcoxia® or Celebrex®
timeFrame: At study entry
measure: Medications Co-Prescribed at Study Entry in Participants Treated With Arcoxia® and Celebrex®
timeFrame: At study entry
measure: Medications Co-Prescribed Over the Course of Follow-up With Arcoxia® and Celebrex®
timeFrame: Up to 12 months
measure: Number of Participants Treated With Other Agents Prior to Initiation of Arcoxia® and Celebrex®
timeFrame: Up to 3 months prior to study entry
measure: Number of Participants Switching to Another Treatment With the Same Reason for Prescription
timeFrame: Up to 12 months
measure: Number of Participants With Contraindications for Use of Arcoxia®
timeFrame: At study entry
measure: Number of Participants Who Experienced at Least One Adverse Event
timeFrame: Up to 12 months
measure: Number of Participants Who Discontinued Study Drug Due to an Adverse Event
timeFrame: Up to 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: