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

Organon

Status and phase

Completed

Phase 4

Conditions

Pain

Treatments

Drug: etoricoxib

Study type

Interventional

Funder types

Industry

Identifiers

NCT00757627

0663-113

2008_029

MK0663-113

Details and patient eligibility

About

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.

Enrollment

500 patients

Sex

All

Ages

20+ years old

Volunteers

No 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)