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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01572675
First received: February 3, 2012
Last updated: July 16, 2014
Last verified: July 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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  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: July 16, 2014
Health Authority: France: ANSM - French Health Products Safety Agency

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 July 24, 2014