Clinical trial: The Single Dose Pharmacokinetics of Two and Proof of Efficacy of One New Etoricoxib Gel Formulation in Participants With Osteoarthritis (MK-0663-168) (NCT01980940)

Eligibility criteria:
Inclusion Criteria

          -  Has diagnosis of osteoarthritis of the knee (tibio-femoral joint) for >6 months based
             on clinical and radiographic criteria;

          -  Has a diagnosis of American Rheumatology Association (ARA) functional Class I, II, or
             III;

          -  The knee designated as the "study joint" must be the participant's primary source of
             pain/disability in the lower extremity. If both knees are affected, the most painful
             joint will be selected for evaluation for inclusion and clinical response;

          -  Female participants of childbearing potential must demonstrate a serum beta human
             chorionic gonadotropin (β-hCG) level consistent with a non-gravid state at the
             screening visit and urine β-hCG at Day -1 prior to first dosing and agree to use
             adequate oral or barrier contraception or abstain from sexual contact at least 7 days
             prior to treatment and continuing through the treatment period or a discontinuation
             visit;

          -  Willing to limit alcohol intake (beer 8 ounces, wine 4 ounces, liquor 1 ounce) to no
             more than 14 drinks a week (no more than 2 in a day) and to avoid unaccustomed
             strenuous physical activity (e.g., unaccustomed weight lifting, initiation of physical
             therapy) for the duration of the study;

          -  Judged to be in general good health with the exception of osteoarthritis based on
             medical history, physical examination, and routine laboratory tests.

          -  For Part 2, if the participant is a regular user of non-steroidal anti-inflammatory
             drugs (NSAIDs) including coxibs he/she must report a history of positive therapeutic
             benefit in osteoarthritis of the knee with NSAID/coxibs in the past;

          -  For Part 2, participants must be taking a single NSAID on a regular basis and at a
             prescription strength for at least 30 days prior to study screening ("regular basis"
             is defined as at least 25 of the previous 30 days) for treatment of symptoms of
             osteoarthritis.

        Exclusion Criteria:

          -  Has a concurrent medical/arthritic disease;

          -  History of acute ligamentous or meniscal injury of the study joint within the previous
             2 years or arthroscopy of the affected knee within 6 months prior to study entry;

          -  Is a candidate for imminent joint replacement;

          -  Has clinical or laboratory evidence of significant renal, gastrointestinal, pulmonary,
             hepatic, endocrine, neurological (apart from migraine), or other systemic disease that
             in the opinion of the investigator contraindicates the use of etoricoxib;

          -  Has congestive heart failure with symptoms that occur at rest or minimal activity;

          -  Has unstable angina that occurs at rest or with minimal activity;

          -  Has uncontrolled hypertension (sitting diastolic blood pressure >95 mm Hg, or sitting
             systolic blood pressure >165 mm Hg);

          -  Has a history of stroke or transient ischemic attack (TIA) within the previous 6
             months;

          -  Has a history of hepatitis/hepatic disease that has been active within the previous 2
             years;

          -  Has a history of neoplastic disease;

          -  Is currently a user (including "recreational use") of any illicit drugs, or has a
             history of drug or alcohol abuse within the past 5 years;

          -  Is allergic of has hypersensitivity to aspirin, ibuprofen, rofecoxib, celecoxib,
             valdecoxib, other NSAIDs, acetaminophen, or sulfa drugs;

          -  Has used intravenous, intramuscular, or oral corticosteroids within 1 month of study
             entry;

          -  Has used glucosamine and/or chondroitin sulfate for <6 months prior to study start;

          -  Has used intra-articular steroids, HYALGAN™ (sodium hyaluronate, Sanofi
             Pharmaceuticals), or SYNVISC™ (hylan G-F 20, Wyeth-Ayerst Pharmaceuticals) to the
             study joint within 3 months of entry into the study or intra-articular steroids,
             HYALGAN™, or SYNVISC™ to any other joint within 1 month of study entry;

          -  Has used topical, oral or systemic analgesic medications within 2 weeks of study entry
             and for the duration of the study;

          -  Requires treatment with warfarin, heparin, high-dose aspirin (>325 mg), or digoxin;

          -  Has used Arcoxia® within 2 weeks of study entry.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 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? Entailment