Status:
COMPLETED
Patient-Reported Effectiveness and Safety of Etoricoxib in Osteoarthritis (OA)(0663-113)
Lead Sponsor:
Organon and Co
Conditions:
Pain
Eligibility:
All Genders
20+ years
Phase:
PHASE4
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.
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT00757627
Start Date
December 1 2007
End Date
December 1 2008
Last Update
February 9 2022
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