OsteoarthritisNCT01685424
Etoricoxib Prescribing Patterns and Adverse Events of Interest in Primary Care in the United Kingdom (MK-0663-162 AM1)
An observational study of Osteoarthritis and Rheumatoid Arthritis, run by Organon and Co.
Trial summary
This postmarketing study was conducted to describe prescribing patterns for etoricoxib (ARCOXIA®) in General Practice and describe the incidence of selected adverse events recorded in the United Kingdom (UK) Medicines and Health Care Products Regulatory Agency (MHRA) General Practice Research Database (GPRD). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoarthritis, Rheumatoid Arthritis, Ankylosing Spondylitis
- What is being tested?
- Etoricoxib
- How many people
- 79,189 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2006to 1 Mar 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All participants in the MHRA's Full Feature GPRD (FF-GPRD) who have at least one electronic outpatient prescription record for etoricoxib issued by a General Practitioner during the period (April 1, 2002 to December 31, 2015) at the date of query execution against the FF-GPRD data warehouse.
Who may be able to join
- All patients in the MHRA's Full Feature GPRD (FF-GPRD) who have at least one electronic outpatient prescription record for etoricoxib issued by a General Practitioner during the period (April 1, 2002 to December 31, 2015) at the date of query execution against the FF-GPRD data warehouse.
Who cannot join
- Not registered in a GPRD-contributing practice that had continuously
- collected data deemed to be 'up-to-standard' for research purposes from 1 April 2002 through to 31 December 2015.
- Never registered as a permanent patient of a General Practitioner in the practice
- Registration details were not acceptable (i.e. incomplete data or logically implausible dates)
- Not registered with a General Practitioner for at least 365 days before the date that the patient's first etoricoxib prescription was recorded in the GPRD
About this study
Official title: Etoricoxib Prescribing Patterns and Adverse Events of Interest During Etoricoxib Treatment in UK Primary Care; an Updated Analysis
This postmarketing study was conducted to describe prescribing patterns for etoricoxib (ARCOXIA®) in General Practice and describe the incidence of selected adverse events recorded in the United Kingdom (UK) Medicines and Health Care Products Regulatory Agency (MHRA) General Practice Research Database (GPRD).
- Conditions
- Osteoarthritis, Rheumatoid Arthritis, Ankylosing Spondylitis, Gout, Arthritis
- Being tested
- Etoricoxib
- Keywords
- Etoricoxib, ARCOXIA, Osteoarthritis, Rheumatoid Arthritis, Ankylosing Spondylitis, Gout, Arthritis
- Medical subject headings
- Osteoarthritis, Arthritis, Rheumatoid, Spondylitis, Ankylosing, Gout, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EtoricoxibDrug
Also called ARCOXIA®)
As per routine clinical practice in the United Kingdom
| Study group | Role | What they receive |
|---|---|---|
| Etoricoxib Prescription (Period 1) | First Etoricoxib Prescription, Apr. 1, 2002 to Feb. 17, 2005 Receives: Drug: Etoricoxib | |
| Etoricoxib Prescription (Period 2) | First Etoricoxib Prescription, Feb. 18, 2005 to Dec. 31, 2015 Receives: Drug: Etoricoxib | |
| Repeat Etoricoxib Prescription | One prescription during the Period 1 and, at least, one etoricoxib prescription during Period 2. Receives: Drug: Etoricoxib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose of Initial Etoricoxib Prescription
Measured: At first prescription (during a time period up to 13.75 years)
Duration of Initial Etoricoxib Prescription
Measured: At first prescription (during a time period up to 13.75 years)
Participant's Baseline Characteristics (Demographics and Medical)
Measured: At first prescription (during a time period up to 13.75 years)
Incidence of Adverse Events of Special Interest Among Etoricoxib Users
Measured: During a time period up to 13.75 years
Secondary outcomes (1)
"Off-label" use of Etoricoxib
Measured: At first prescription (during a time period up to 13.75 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2012 (estimated)
- Study start30 Jun 2006
- Primary completion1 Mar 2015
- Study completion1 Mar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 79,189 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01685424
- Sponsor's protocol ID
- 0663-162
- Other IDs
- 7013.021, EMEA/H/A - 31/632
- Status last verified
- Feb 2022
- First submitted
- 23 Aug 2012
- Last updated
- 18 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Etoricoxib Prescribing Patterns and Adverse Events of Interest During Etoricoxib Treatment in UK Primary Care; an Updated Analysis
- ClinicalTrials.gov ID
- NCT01685424
- Acronym / sponsor ID
- 0663-162
- Conditions
- Osteoarthritis, Rheumatoid Arthritis, Ankylosing Spondylitis, Gout, Arthritis
- Keywords
- Etoricoxib, ARCOXIA, Osteoarthritis, Rheumatoid Arthritis, Ankylosing Spondylitis, Gout, Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 79,189 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- 30 Jun 2006 (actual)
- Primary completion
- 1 Mar 2015 (actual)
- Study completion
- 1 Mar 2015 (actual)
- First posted
- 14 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This postmarketing study was conducted to describe prescribing patterns for etoricoxib (ARCOXIA®) in General Practice and describe the incidence of selected adverse events recorded in the United Kingdom (UK) Medicines and Health Care Products Regulatory Agency (MHRA) General Practice Research Database (GPRD).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Etoricoxib Prescription (Period 1) | – | Drug: EtoricoxibFirst Etoricoxib Prescription, Apr. 1, 2002 to Feb. 17, 2005 |
| Etoricoxib Prescription (Period 2) | – | Drug: EtoricoxibFirst Etoricoxib Prescription, Feb. 18, 2005 to Dec. 31, 2015 |
| Repeat Etoricoxib Prescription | – | Drug: EtoricoxibOne prescription during the Period 1 and, at least, one etoricoxib prescription during Period 2. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All participants in the MHRA's Full Feature GPRD (FF-GPRD) who have at least one electronic outpatient prescription record for etoricoxib issued by a General Practitioner during the period (April 1, 2002 to December 31, 2015) at the date of query execution against the FF-GPRD data warehouse.
Key inclusion criteria (1 listed)
- All patients in the MHRA's Full Feature GPRD (FF-GPRD) who have at least one electronic outpatient prescription record for etoricoxib issued by a General Practitioner during the period (April 1, 2002 to December 31, 2015) at the date of query execution against the FF-GPRD data warehouse.
Key exclusion criteria (5 listed)
- Not registered in a GPRD-contributing practice that had continuously
- collected data deemed to be 'up-to-standard' for research purposes from 1 April 2002 through to 31 December 2015.
- Never registered as a permanent patient of a General Practitioner in the practice
- Registration details were not acceptable (i.e. incomplete data or logically implausible dates)
- Not registered with a General Practitioner for at least 365 days before the date that the patient's first etoricoxib prescription was recorded in the GPRD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EtoricoxibAlso: ARCOXIA®)As per routine clinical practice in the United Kingdom | Drug | Etoricoxib Prescription (Period 1), Etoricoxib Prescription (Period 2), Repeat Etoricoxib Prescription |
Primary outcome
Dose of Initial Etoricoxib Prescription
Time frame: At first prescription (during a time period up to 13.75 years)
Duration of Initial Etoricoxib Prescription
Time frame: At first prescription (during a time period up to 13.75 years)
Participant's Baseline Characteristics (Demographics and Medical)
Time frame: At first prescription (during a time period up to 13.75 years)
Incidence of Adverse Events of Special Interest Among Etoricoxib Users
Time frame: During a time period up to 13.75 years
1 secondary outcome
"Off-label" use of Etoricoxib
Time frame: At first prescription (during a time period up to 13.75 years)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2022.
- EU PAS Register (EUPAS17526)Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis and Rheumatoid Arthritis, run by Organon and Co.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose of Initial Etoricoxib Prescription (time frame: At first prescription (during a time period up to 13.75 years)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2022.