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

Organon and Co500 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

500

Conditions

Pain

Interventions

etoricoxibDRUG

etoricoxib 60 mg QD for 4 weeks.

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

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

Secondary Outcomes

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.

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)

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.

Time frame: 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.

Time frame: Week 4

Patient Assessment of General Health Outcome by EuroQoL-5 Dimensions (EQ-5D) at Baseline

Data from ClinicalTrials.gov

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