Clinical trial: A Study of Etoricoxib in Participants With Osteoarthritis Not Responding to Analgesic Drugs (MK-0663-142) (NCT01429168)

Eligibility criteria:
Inclusion Criteria:

          -  Clinical diagnosis of osteoarthritis of the knee or hip that requires treatment

          -  American Rheumatism Association (ARA) functional Class I, II or III

          -  Receiving a stable dose of a traditional non-steroidal anti-inflammatory drug (NSAID),
             a Cox-2 selective inhibitor (other than etoricoxib, e.g. celecoxib), opioid therapy or
             tramadol to treat their osteoarthritis-related pain for at least 2 weeks and willing
             to maintain treatment during baseline phase

          -  Moderate to severe daily pain intensity on his or her current pain regimen

          -  Excepting osteoarthritis, patient is judged to be in otherwise general good health
             based on medical history, physical examination, and routine laboratory tests

          -  Negative serum pregnancy test

        Exclusion Criteria:

          -  Has not experienced at least 3 consecutive days of daily pain intensity >4 on 10-point
             scale

          -  Severe hepatic insufficiency

          -  Advanced renal insufficiency

          -  Presence of gastro-intestinal ulcer disease with active bleeding or history of the
             same within the past 6 months or a presence or history of inflammatory bowel disease

          -  History of gastric, biliary (including gastric bypass surgery), or small intestinal
             surgery that results in clinical malabsorption

          -  Receiving or will likely require treatment with ≥14 consecutive days or repeated
             courses of pharmacologic doses of corticosteroids

          -  Established ischemic heart disease, peripheral arterial disease, and/or
             cerebrovascular disease including a history of stroke, myocardial infarction or
             transient ischemic attack, and recent revascularization procedures

          -  Any other contraindications mentioned in the approved study drug European Union (EU)
             Summary of Product Characteristics (SmPC)

          -  Therapy with glucosamine and/or chondroitin sulfate for <6 months prior to study
             start.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 50 Years old.


Patient description (medical language): A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee.

Patient description (patient's own words): I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee.

Does the patient match the trial criteria? Contradiction