PainPhase 4NCT00757627

Patient-Reported Effectiveness and Safety of Etoricoxib in Osteoarthritis (OA)(0663-113)

A Phase 4 study testing etoricoxib in people with Pain, run by Organon and Co.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to collect disease burden of OA and the effectiveness and patient satisfaction of treatment by Etoricoxib in the normal practice setting. Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Pain
What is being tested?: etoricoxib
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 500 participants
Where: No sites listed yet
Study dates: Dec 2007to Dec 2008
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Must Be Over 20 Years Of Age, Regardless Of Sex
Must Have A Diagnosis Of OA That Requiring Treatment
Patients Must Have Taken an NSAID, Cox-2 Or Opioids On The Majority Of Days During The Last 4 Weeks Before Enrollment Who Are Intolerant (Due To Gastrointestinal Adverse Events) Or Inadequately Respond To Current Therapy (Vas >= 40 mm On A Pain Scale From 0-100 mm)
Excluding Osteoarthritis, The Patient Is Judged To Be In Otherwise General Good Health Based On Medical History, Physical Examination, And Routine Laboratory Tests
Must Agree To Participate Voluntarily In The Study
Must Have The Capacity To Understand And Answer The Questionnaires Used In The Study
Must Agree To Return For A Follow-Up Visit With The Treating Physician Four Weeks After The Initiation Of Treatment With Etoricoxib
Patient Is Willing To Sign Informed Consent Form

Who cannot join

Under 20 Years Of Age
Severe Hepatic Insufficiency (Child-Pugh Score > 9)
Advanced Renal Insufficiency (Creatinine Clearance < 30 Ml/Min)
Any Contraindication Or Warning Or Precaution As Mentioned In The Approved Study Drug Package Insert
Gi Ulcer With Active Bleeding Present At Study Enrollment
Patient Has A Recent History Of Stroke, Myocardial Infarction Or Transient Ischemic Attack (Within The Previous 2 Years)

About this study

Official title: Patient-reported Outcomes With Etoricoxib in Real Life

The purpose of this study is to collect disease burden of OA and the effectiveness and patient satisfaction of treatment by Etoricoxib in the normal practice setting.

Conditions: Pain
Being tested: etoricoxib
Medical subject headings: Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

etoricoxibDrug
Also called Arcoxia
etoricoxib 60 mg QD for 4 weeks.

Study groups in NCT00757627
Study group	Role	What they receive
1	Experimental	Etoricoxib Receives: Drug: etoricoxib

What is being measured

The primary outcome is the main question the study is designed to answer.

The Percentage of Participants Achieving ≥30% Decrease From Baseline in Pain Intensity as Measured by WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) Question 1 "Pain Walking on a Flat Surface" at Week 4
WOMAC for pain assessment by patient (0-100 mm Visual Analog Scale (VAS) with 0 represent "no pain" and 100 represent "extreme pain")
Measured: Baseline and end of week 4

Secondary outcomes (9)

Mean Change From Baseline in Patient WOMAC Domain Scores at Week 4
The change from baseline in 3 domain scores (pain, stiffness, and difficult in doing daily activity) of WOMAC at week 4 were measured. Each domain comprises of questions and VAS scales for scoring. For pain domain, 0 represents no pain and 100 represents extreme pain; for stiffness domain, 0 represents no stiffness and 100 represents extreme stiffness; for difficult in doing daily activity domain, 0 represents no difficulty and 100 represents most difficulty.
Measured: Baseline and Week 4
Physicians' Global Assessment of Patients' Response to Therapy at Baseline Using IGART (Investigator Global Assessment of Response to Therapy)
The IGART comprised of five categories: No response, poor response, fair response, good response, and excellent response. The percentage of participants who met the criteria of any of the 5 categories at baseline were collected.
Measured: Baseline
Physicians' Global Assessment of Patients' Response to Therapy at Week 4 Using IGART
The IGART comprised of five categories: No response, poor response, fair response, good response, and excellent response. The percentage of participants met the criteria of any of the 5 categories at week 4 were collected.
Measured: Week 4
Patient Assessment of General Health Outcome by EuroQoL-5 Dimensions (EQ-5D) at Baseline
The percentage of participants who met the criteria of any of the 3 categories of EQ-5D at baseline and at week 4 were collected.The EQ-5D comprises of 5 dimensions (mobility, self-care, usual activities, pain / discomfort, and anxiety / depression) to be answered using a 3-categorical Likert's scales of: [No problem, Some problem, and Not able to carry out] for mobility, self-care and usual activities and [Not present, moderate and extreme] for discomfort and anxiety/depression.
Measured: Baseline
Patient Assessment of General Health Outcome by EuroQoL-5 Dimensions (EQ-5D) at Week 4
The percentage of participants who met the criteria of any of the 3 categories of EQ-5D at baseline and at week 4 were collected.The EQ-5D comprises of 5 dimensions (mobility, self-care, usual activities, pain / discomfort, and anxiety / depression) to be answered using a 3-categorical Likert's scales of: [No problem, Some problem, and Not able to carry out] for mobility, self-care and usual activities and [ Not present, moderate and extreme]for discomfort and anxiety/depression
Measured: Week 4
Change From Baseline of Patient BPI (Brief Pain Inventory) Scores at Week 4
BPI consists of pain and pain interference domains. For pain (0=no pain to 10=extreme pain); for pain interference ( 0=no interference to 10= greatest interference).
Measured: Baseline and Week 4
Changes From Baseline in Patient TSQM (Treatment Satisfaction Questionnaire for Medication) Domain Scores at Week 4
TSQM consists of four domains (effectiveness; side effect; convenience and overall satisfaction), domain scores ranged from 0 (0=worst) to 100 (100=best) were derived from converting the original Likert's scales to VAS scale.
Measured: Baseline and Week 4
Change From Baseline in Number of Days Patient Miss From Work or House Keeping Work at Week 4
Measured: Baseline and Week 4
Change From Baseline in Patient-SF36 (Short Form 36) Domain Scores at Week 4
Weighted scores of the 8 domains of SF36 (i.e., physical functioning; role limiting due to physical problem; bodily pain; general health; vitality; social functioning; role limiting due to emotional problem; mental health) were scored on a scale from 0 ~100, with 100 representing the best possible functioning)
Measured: Baseline and Week 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2007Dec 2008

First posted23 Sep 2008 (estimated)
Study startDec 2007
Primary completionDec 2008
Study completionDec 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for PainStudies 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: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 500 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00757627
Sponsor's protocol ID: 0663-113
Other IDs: MK0663-113, 2008_029
Status last verified: Feb 2022
First submitted: 22 Sep 2008
Last updated: 9 Feb 2022
Results posted: Yes, on ClinicalTrials.gov

Publications

Lin HY, Cheng TT, Wang JH, Lee CS, Chen MH, Lei V, Lac C, Gammaitoni AR, Smugar SS, Chen WJ. Etoricoxib improves pain, function and quality of life: results of a real-world effectiveness trial. Int J Rheum Dis. 2010 May;13(2):144-50. doi: 10.1111/j.1756-185X.2010.01468.x.
PubMed 20536599

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Patient-reported Outcomes With Etoricoxib in Real Life
ClinicalTrials.gov ID: NCT00757627
Acronym / sponsor ID: 0663-113
Conditions: Pain
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 500 participants (actual)
Lead sponsor: Organon and CoIndustry (pharma, biotech, devices)
Study start: Dec 2007
Primary completion: Dec 2008 (actual)
Study completion: Dec 2008 (actual)
First posted: 23 Sep 2008 (estimated)
Results: Posted 11 May 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to collect disease burden of OA and the effectiveness and patient satisfaction of treatment by Etoricoxib in the normal practice setting.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
1	Experimental	Drug: etoricoxibEtoricoxib

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Must Be Over 20 Years Of Age, Regardless Of Sex
Must Have A Diagnosis Of OA That Requiring Treatment
Patients Must Have Taken an NSAID, Cox-2 Or Opioids On The Majority Of Days During The Last 4 Weeks Before Enrollment Who Are Intolerant (Due To Gastrointestinal Adverse Events) Or Inadequately Respond To Current Therapy (Vas >= 40 mm On A Pain Scale From 0-100 mm)
Excluding Osteoarthritis, The Patient Is Judged To Be In Otherwise General Good Health Based On Medical History, Physical Examination, And Routine Laboratory Tests
Must Agree To Participate Voluntarily In The Study

Key exclusion criteria (6 listed)

Under 20 Years Of Age
Severe Hepatic Insufficiency (Child-Pugh Score > 9)
Advanced Renal Insufficiency (Creatinine Clearance < 30 Ml/Min)
Any Contraindication Or Warning Or Precaution As Mentioned In The Approved Study Drug Package Insert
Gi Ulcer With Active Bleeding Present At Study Enrollment

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: Arcoxiaetoricoxib 60 mg QD for 4 weeks.	Drug	1

Primary outcome

The Percentage of Participants Achieving ≥30% Decrease From Baseline in Pain Intensity as Measured by WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) Question 1 "Pain Walking on a Flat Surface" at Week 4
Time frame: Baseline and end of week 4
WOMAC for pain assessment by patient (0-100 mm Visual Analog Scale (VAS) with 0 represent "no pain" and 100 represent "extreme pain")

9 secondary outcomes

Mean Change From Baseline in Patient WOMAC Domain Scores at Week 4
Time frame: Baseline and Week 4
Physicians' Global Assessment of Patients' Response to Therapy at Baseline Using IGART (Investigator Global Assessment of Response to Therapy)
Time frame: Baseline
Physicians' Global Assessment of Patients' Response to Therapy at Week 4 Using IGART
Time frame: Week 4
Patient Assessment of General Health Outcome by EuroQoL-5 Dimensions (EQ-5D) at Baseline
Time frame: Baseline
Patient Assessment of General Health Outcome by EuroQoL-5 Dimensions (EQ-5D) at Week 4
Time frame: Week 4
Change From Baseline of Patient BPI (Brief Pain Inventory) Scores at Week 4
Time frame: Baseline and Week 4
Changes From Baseline in Patient TSQM (Treatment Satisfaction Questionnaire for Medication) Domain Scores at Week 4
Time frame: Baseline and Week 4
Change From Baseline in Number of Days Patient Miss From Work or House Keeping Work at Week 4
Time frame: Baseline and Week 4
Change From Baseline in Patient-SF36 (Short Form 36) Domain Scores at Week 4
Time frame: Baseline and Week 4

Results and safety

Results posted to the registry on 11 May 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Etoricoxib	500	419

Primary outcome: The Percentage of Participants Achieving ≥30% Decrease From Baseline in Pain Intensity as Measured by WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) Question 1 "Pain Walking on a Flat Surface" at Week 4

Time frame: Baseline and end of week 4. Number. Unit: Percentage of Participants

Measure	Etoricoxib n = 392
Value	52.04

Population analysed: Per protocol (all patients who completed the WOMAC"pain walking on a flat surface " question at baseline and follow up visit at week 4 will be included for analysis of this endpoint. Among the 419 patients with follow up visit data, 27 patients rated 0 in their VAS pain score at baseline and were excluded from this analysis.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: From baseline to end of week 4. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Etoricoxib	6 of 500 (1.2%)	82 of 500 (16.4%)	Not reported

Limitations and caveats (from the sponsor): Open-labeled, non-controlled

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 20536599Lin HY, Cheng TT, Wang JH, Lee CS, Chen MH, Lei V, Lac C, Gammaitoni AR, Smugar SS, Chen WJ. Etoricoxib improves pain, function and quality of life: results of a real-world effectiveness trial. Int J Rheum Dis. 2010 May;13(2):144-50. doi: 10.1111/j.1756-185X.2010.01468.x.

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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.

Medical Monitor study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing etoricoxib in people with Pain, 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 8 inclusion and 6 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 9 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 May 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

The Percentage of Participants Achieving ≥30% Decrease From Baseline in Pain Intensity as Measured by WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) Question 1 "Pain Walking on a Flat Surface" at Week 4 (time frame: Baseline and end of week 4). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00757627, which also lists 1 linked publication.

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 9 Feb 2022.