A Study of the Patterns of Use of Etoricoxib in France (MK-0663-148)

This study is currently recruiting participants.
Verified March 2014 by Merck Sharp & Dohme Corp.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01572675
First received: February 3, 2012
Last updated: March 12, 2014
Last verified: March 2014
  Purpose

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


Condition
Osteoarthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pharmacoepidemiological Study on the Use of Arcoxia® Under Actual Conditions of Use in France

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Dose (in milligrams) of etoricoxib or celecoxib prescribed [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
  • Number of participants with a given duration of prescription of etoricoxib or celecoxib use [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
  • Number of participants with a given reason for prescribing etoricoxib or celecoxib [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of participants discontinuing treatment with etoricoxib or celecoxib for a particular reason [ Time Frame: Up to 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 852
Study Start Date: June 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Etoricoxib
Participants prescribed etoricoxib in routine clinical practice.
Celecoxib Group
Participants prescribed celecoxib in routine clinical practice.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Participants spontaneously consulting a general practitioner or rheumatologist and having agreed to take part in this study.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01572675

Contacts
Contact: Toll-Free Number 1-888-577-8839

Locations
France
MSD France Recruiting
Paris, France
Contact: Dominique Blazy    33 147548990      
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01572675     History of Changes
Other Study ID Numbers: 0663-148
Study First Received: February 3, 2012
Last Updated: March 12, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Merck Sharp & Dohme Corp.:
Pharmacoepidemiological
Longitudinal
Observational

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Etoricoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Therapeutic Uses
Central Nervous System Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on April 17, 2014