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

Study Overview
=================
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.

Official Title
-----------------
Patient-reported Outcomes With Etoricoxib in Real Life

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: etoricoxib


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Etoricoxib | Drug: etoricoxib<br>* etoricoxib 60 mg QD for 4 weeks.<br>* Other names: Arcoxia;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Baseline and end of week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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 | 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). | 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. | Baseline and Week 4 | 
| 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 | 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) | Baseline and Week 4 |