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

NCT01572675 | Completed Results

• 1 other identifier: 0663-148
• Study Type: observational
• Target: 547
• Locations: 0 countries
• Sites: N/A

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®).

Conditions

Osteoarthritis

Keywords

Pharmacoepidemiological; Longitudinal; Observational

Outcome Measures

Primary Outcomes (12)

• Number of Participants Demonstrating Proper Use of Arcoxia® and Celebrex®

  Proper use of study medication is defined as administration of medication in terms of indication and dosage according to Market Authorization (MA). Proper use of Arcoxia® is defined as administration of a starting dose of 30 mg daily, not to exceed 60 mg daily during follow-up, for the treatment of symptoms of osteoarthritis. Proper use of Celebrex® is defined as administration of a starting dose of 200 mg daily, not to exceed 400 mg daily during follow-up, for easing symptoms in the treatment of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. Data to assess proper use were collected through use of a medical questionnaire and patient form. Data pertaining to indication was collected by open-field to allow physicians to precisely indicate the reason for prescription. Recorded indications were then analyzed by two medical experts (an independent expert and a member of the Scientific Community) to assess proper use or misuse.

  Up to 12 months

• Reasons for Misuse of Arcoxia® and Celebrex®

  Proper use of study medication is defined as administration of medication in terms of indication and dosage according to MA. Proper use of Arcoxia® is defined as administration of a starting dose of 30 mg daily, not to exceed 60 mg daily during follow-up, for the treatment of symptoms of osteoarthritis. Proper use of Celebrex® is defined as administration of a starting dose of 200 mg daily, not to exceed 400 mg daily during follow-up, for easing symptoms in the treatment of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. Data to assess proper use were collected through use of a medical questionnaire and patient form. Data pertaining to indication was collected by open-field to allow physicians to precisely indicate the reason for prescription. Recorded indications were then analyzed by two medical experts (an independent expert and a member of the Scientific Community) to assess proper use or misuse.

  Up to 12 months

• Indications for Which Arcoxia® and Celebrex® Were Prescribed

  The reasons (indications) for prescribing of Arcoxia® or Celebrex® were collected in open-field forms by the Investigator; category assignment (i.e, re-codification) of verbatim entries was conducted by a group of medical experts under the guidance approved by the MA. This endpoint gives the number of participants treated per indication.

  At study entry

• Dosage of Arcoxia® and Celebrex® at Initiation

  Dosage at initiation of treatment with Arcoxia® or Celebrex® was identified. MA compliant dosage at initiation corresponds to a (starting) dose of 30 mg daily for Arcoxia® or a (starting) dose of 200 mg daily for Celebrex®. The dose for initiation was calculated by multiplying the number of doses per day with the dose level (total daily dose) as noted in the prescription record.

  At study entry

• Mean Dosage of Arcoxia® and Celebrex® During Treatment

  The mean dosage of Arcoxia® and Celebrex® during treatment was determined. For participants who stopped treatment after their initial study visit, the maximum dose recorded at their final study visit was considered when calculating their mean dosage during treatment.

  Up to 12 months

• Number of Participants Requiring Dose Modification of Arcoxia® and Celebrex®

  Participants requiring modifications to their Arcoxia® or Celebrex® dose regimens during their on study treatment course were identified. Dose modifications were defined as an increase, decrease followed by increase, decrease, or increase followed by decrease in the participant's daily dose; all categorizations were exclusive. If the maximum dose at discontinuation of treatment was greater than that at initiation, the participant was considered as having had an increase in dose during treatment. Alternatively, if data obtained from a participant's prescription records showed a successive lowering of dosage, the participant was considered as having had a decrease in dose during treatment. Dosages at baseline were included in the dose modification determination for treatment renewal participants.

  Up to 12 months

• Duration of Prescription for Arcoxia® and Celebrex® at Enrollment

  The mean duration of prescription at enrollment for participants treated with Arcoxia® and Celebrex® was determined using the participant's record.

  Up to 3 months prior to study entry

• Total Duration of Treatment With Arcoxia® and Celebrex®

  The total duration of treatment (DoT) with Arcoxia® or Celebrex® was determined for populations that achieved end-of study and end-of-protocol or that were categorized as lost to follow-up. Participants enumerated as end-of-study had their treatment discontinued during the protocol-specified one year of follow-up. Participants enumerated as end-of-protocol were ongoing treatment at end of the protocol-specified one year of follow-up. Participants categorized as lost to follow-up had no follow-up visit where a determination of discontinuation from treatment could be made.

  Up to 12 months

• Maximum Dosage Prescribed During Treatment With Arcoxia® and Celebrex®

  Mean maximum dosage prescribed during follow-up in participants treated with Arcoxia® or Celebrex®. Dosage is expressed as total daily dose.

  Up to 12 months

• Reasons for Discontinuation of Treatment With Arcoxia® and Celebrex®

  The individual reasons for discontinuation of treatment with Arcoxia® or Celebrex® were identified over the course of study through either physician selection from a pre-determined list or verbatim entry by the physician with subsequent re-codification by Sponsor.

  Up to 12 months

• Type of Arcoxia® and Celebrex® Use

  The type of Arcoxia® or Celebrex® use during the study was classified as continuous (without interruption \>7 days) or intermittent (with interruption \>7 days) by the Investigating Physician at time of treatment discontinuation.

  Up to 12 months

• Type of Arcoxia® and Celebrex® Use According to Duration of Treatment

  Use of selective cyclooxygenase-2 (COX-2) inhibitors (Arcoxia® and Celebrex®) as assessed by the Investigating Physician at time of treatment discontinuation was correlated to the overall duration of treatment experienced by the participant (i.e., intermittent or continuous selective COX-2 inhibitor use vs. total participant time on treatment). Type of use was classified as continuous (without interruption \>7 days) or intermittent (with interruption \>7 days). Four successive treatment intervals were assessed in this endpoint: 1) Up to thirty days of treatment 2) From one to three months of treatment 3) From three months to one year of treatment and 4) More than one year of treatment.

  Up to 12 months

Secondary Outcomes (13)

• Mean Body Mass Index (BMI) at Study Entry in Participants Treated With Arcoxia® and Celebrex®

  At study entry (baseline)

• Mean Systolic and Diastolic Blood Pressure (BP) at Study Entry in Participants Treated With Arcoxia® and Celebrex®

  At study entry (baseline)

• Blood Pressure at Study Entry in Participants Treated With Arcoxia® and Celebrex®

  At study entry (baseline)

• Medical History of Participants Treated With Arcoxia® and Celebrex®

  At study entry

• Co-morbidities in Participants Treated With Arcoxia® and Celebrex®

  At study entry

Study Arms (2)

Group Arcoxia®

Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.

Drug: etorocoxib

Group Celebrex®

Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.

Drug: celecoxib

Interventions

etorocoxib DRUG

Administered as 30 mg or 60 mg oral film-coated tablets

Also known as: Arcoxia®

Group Arcoxia®

celecoxib DRUG

Administered as 100 mg or 200 mg oral hard capsules

Also known as: Celebrex®

Group Celebrex®

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Organon and Co: lead

MeSH Terms

Conditions

Osteoarthritis

Interventions

Etoricoxib; Celecoxib

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Sulfones; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzenesulfonamides; Sulfonamides; Amides; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Pyrazoles; Azoles

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2012
• First Posted: April 6, 2012
• Study Start: June 1, 2012
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: February 9, 2022
• Results First Posted: May 25, 2016

Record last verified: 2022-02