Clinical trial NCT00757627: Patient-Reported Effectiveness and Safety of Etoricoxib in Osteoarthritis (OA)(0663-113)
Official title: Patient-reported Outcomes With Etoricoxib in Real Life
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2008-09-23
Enrollment: 500
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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)

Primary outcomes:
measure: 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
timeFrame: Baseline and end of week 4
Secondary outcomes:
measure: Mean Change From Baseline in Patient WOMAC Domain Scores at Week 4
timeFrame: Baseline and Week 4
measure: Physicians' Global Assessment of Patients' Response to Therapy at Baseline Using IGART (Investigator Global Assessment of Response to Therapy)
timeFrame: Baseline
measure: Physicians' Global Assessment of Patients' Response to Therapy at Week 4 Using IGART
timeFrame: Week 4
measure: Patient Assessment of General Health Outcome by EuroQoL-5 Dimensions (EQ-5D) at Baseline
timeFrame: Baseline
measure: Patient Assessment of General Health Outcome by EuroQoL-5 Dimensions (EQ-5D) at Week 4
timeFrame: Week 4
measure: Change From Baseline of Patient BPI (Brief Pain Inventory) Scores at Week 4
timeFrame: Baseline and Week 4
measure: Changes From Baseline in Patient TSQM (Treatment Satisfaction Questionnaire for Medication) Domain Scores at Week 4
timeFrame: Baseline and Week 4
measure: Change From Baseline in Number of Days Patient Miss From Work or House Keeping Work at Week 4
timeFrame: Baseline and Week 4
measure: Change From Baseline in Patient-SF36 (Short Form 36) Domain Scores at Week 4
timeFrame: Baseline and Week 4
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Lin HY, Cheng TT, Wang JH, Lee CS, Chen MH, Lei V, Lac C, Gammaitoni AR, Smugar SS, Chen WJ. Etoricoxib improves pain, function and quality of life: results of a real-world effectiveness trial. Int J Rheum Dis. 2010 May;13(2):144-50. doi: 10.1111/j.1756-185X.2010.01468.x.