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

Patient-reported Outcomes With Etoricoxib in Real Life

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00757627

Enrollment

500

Registered

2008-09-23

Start date

2007-12-31

Completion date

2008-12-31

Last updated

2022-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Brief 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.

Interventions

DRUGetoricoxib

etoricoxib 60 mg QD for 4 weeks.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

* 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)

Design outcomes

Primary

Measure	Time frame	Description
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	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)

Secondary

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

Participant flow

Participants by arm

Arm	Count
Etoricoxib Etoricoxib 60 mg once a day (q.d.)	500
Total	500

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Adverse Event	15
Overall Study	Lack of Efficacy	10
Overall Study	Lost to Follow-up	28
Overall Study	Other	1
Overall Study	Withdrawal by Subject	27

Baseline characteristics

Characteristic	Etoricoxib
Age, Continuous	66.6 years STANDARD_DEVIATION 10.9
Patient-SF36 (Short form 36) domain scores SF-36 Bodily pain	52.4 Units on a scale STANDARD_DEVIATION 63.9
Patient-SF36 (Short form 36) domain scores SF-36 General health	52.7 Units on a scale STANDARD_DEVIATION 54.5
Patient-SF36 (Short form 36) domain scores SF-36 Mental health	61.7 Units on a scale STANDARD_DEVIATION 66.3
Patient-SF36 (Short form 36) domain scores SF-36 Physical functional	45.1 Units on a scale STANDARD_DEVIATION 51.3
Patient-SF36 (Short form 36) domain scores SF-36 Role limitation due to emotional problem	41.3 Units on a scale STANDARD_DEVIATION 56.6
Patient-SF36 (Short form 36) domain scores SF-36 Role limitation due to physical problem	24.0 Units on a scale STANDARD_DEVIATION 42.5
Patient-SF36 (Short form 36) domain scores SF-36 Social functioning	69.0 Units on a scale STANDARD_DEVIATION 78.3
Patient-SF36 (Short form 36) domain scores SF-36 Vitality	55.9 Units on a scale STANDARD_DEVIATION 57.6
Sex: Female, Male Female	365 Participants
Sex: Female, Male Male	135 Participants
The mean of patient BPI (Brief Pain Inventory) scores BPI-Average pain	4.9 Units on a scale STANDARD_DEVIATION 3.8
The mean of patient BPI (Brief Pain Inventory) scores BPI - Enjoyment of life	3.0 Units on a scale STANDARD_DEVIATION 2.1
The mean of patient BPI (Brief Pain Inventory) scores BPI -Interference on general activities	2.9 Units on a scale STANDARD_DEVIATION 2.1
The mean of patient BPI (Brief Pain Inventory) scores BPI -Least pain	3.2 Units on a scale STANDARD_DEVIATION 2.5
The mean of patient BPI (Brief Pain Inventory) scores BPI - Mood	3.2 Units on a scale STANDARD_DEVIATION 2.2
The mean of patient BPI (Brief Pain Inventory) scores BPI - Normal work	4.2 Units on a scale STANDARD_DEVIATION 2.9
The mean of patient BPI (Brief Pain Inventory) scores BPI -Pain right now	4.4 Units on a scale STANDARD_DEVIATION 3.1
The mean of patient BPI (Brief Pain Inventory) scores BPI- Relations with other people	2.5 Units on a scale STANDARD_DEVIATION 1.9
The mean of patient BPI (Brief Pain Inventory) scores BPI - Sleep	3.3 Units on a scale STANDARD_DEVIATION 2.3
The mean of patient BPI (Brief Pain Inventory) scores BPI -Walking	4.3 Units on a scale STANDARD_DEVIATION 2.9
The mean of patient BPI (Brief Pain Inventory) scores BPI -Worst pain	6.4 Units on a scale STANDARD_DEVIATION 4.9
The mean of patient WOMAC ( Western Ontario and McMaster Universities Osteoarthritis Index) subscale WOMAC Pain subscale	38.5 Units on a Scale STANDARD_DEVIATION 22.9
The mean of patient WOMAC ( Western Ontario and McMaster Universities Osteoarthritis Index) subscale WOMAC Physical Function subscale	38.0 Units on a Scale STANDARD_DEVIATION 24.8
The mean of patient WOMAC ( Western Ontario and McMaster Universities Osteoarthritis Index) subscale WOMAC Stiffness subscale	36.3 Units on a Scale STANDARD_DEVIATION 26.9
TSQM (Treatment Satisfaction Questionnaire for Medication )domain scores TSQM - Convenience	68.0 Units on a scale STANDARD_DEVIATION 68.8
TSQM (Treatment Satisfaction Questionnaire for Medication )domain scores TSQM - Effectiveness	52.1 Units on a scale STANDARD_DEVIATION 55.6
TSQM (Treatment Satisfaction Questionnaire for Medication )domain scores TSQM - Overall satisfaction	44.1 Units on a scale STANDARD_DEVIATION 45.7
TSQM (Treatment Satisfaction Questionnaire for Medication )domain scores TSQM - Side effect	56.9 Units on a scale STANDARD_DEVIATION 55.7

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	82 / 500
serious Total, serious adverse events	6 / 500

Outcome results

Primary

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)

Time frame: Baseline and end of week 4

Population: Per protocol (all patients who completed the WOMACpain 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.

Arm	Measure	Value (NUMBER)
Etoricoxib	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	52.04 Percentage of Participants

Secondary