Clinical trial: A Study Comparing Duloxetine Versus Placebo in Patients Taking a Nonsteroidal Anti-inflammatory Drug (NSAID) for Knee Pain Due to Osteoarthritis (NCT01018680)

Eligibility criteria:
Inclusion Criteria:

          -  Present with knee pain due to osteoarthritis (OA) based on OA clinical and
             radiographic diagnostic criteria.

          -  Knee Pain for > 14 days of each month for the 3 months directly preceding study entry.

          -  Taking nonsteroidal anti-inflammatory drugs (NSAIDs) for knee pain due to OA on most
             days in the 3 months immediately preceding study entry.

        Exclusion Criteria:

          -  History of intolerance or nonresponsiveness to an adequate trial of duloxetine used
             for any indication, in the opinion of the investigator.

          -  Previous diagnosis of psychosis, bipolar disorder, or schizoaffective disorder.

          -  Have major depressive disorder (MDD) as determined using depression module of the Mini
             International Neuropsychiatric Interview (MINI).

          -  Judged clinically by the investigator to be at suicidal risk by examination or using
             the Columbia Suicide Severity Rating Scale (C-SSRS).

          -  History of substance abuse or dependence within the past year, excluding nicotine and
             caffeine.

          -  Positive urine drug screen for any substance of abuse or excluded medication.

          -  Opioid dependent in the opinion of the investigator, taking opioids more than 3 days a
             week, or unwilling to discontinue opioids during the study period.

          -  Known hypersensitivity to duloxetine or its inactive ingredients.

          -  History of intolerance or hypersensitivity to NSAIDS, Cyclooxygenase (COX-2)
             inhibitors, or proton pump inhibitors.

          -  History of peptic ulcer disease, bleeding disorder, gastrointestinal bleeding, or any
             abnormal bleeding.

          -  Baseline hemoglobin measurement of <11 grams per deciliter (g/dL) for males, or <10
             g/dL for females.

          -  Serious or unstable cardiovascular, hepatic, renal, metabolic, respiratory, or
             hematologic illness, symptomatic peripheral vascular disease, or any other medical or
             psychiatric condition that would compromise participation or be likely to lead to
             hospitalization or a change in medication during the course of the study.

          -  Uncorrected thyroid disease, uncontrolled narrow-angle glaucoma, uncontrolled or
             poorly controlled hypertension, or history of seizures.

          -  Active liver injury (such as hepatitis) or any degree of hepatic insufficiency
             (Child-Pugh Class C).

          -  Frequent falls that could result in hospitalization or could compromise response to
             treatment.

          -  Confounding painful condition that may interfere with assessment of the index knee.

          -  Chronic widespread pain affecting all four quadrants of the body, or diagnosis of
             fibromyalgia.

          -  Received intra-articular hyaluronate (Synvisc), steroids, joint lavage, or other
             invasive therapies to the knee in the past 6 months.

          -  Arthroscopy of the index knee within the past year or joint replacement of the index
             knee at anytime.

          -  Diagnosis of inflammatory arthritis (that is, rheumatoid arthritis, psoriatic
             arthritis, reactive arthritis, ankylosing spondylitis, etc.) or an autoimmune disorder
             (excluding inactive Hashimoto's thyroiditis).

          -  Prior synovial fluid analysis showing a white blood cell count greater than or equal
             to 2000 cubic millimeters (mm^3) that is indicative of a diagnosis other than OA, or
             have a history of gout or pseudogout.

          -  Radiographic evidence of end-stage (bone on bone) OA in either knee.

          -  Knee replacement surgery planned within the next 6 months.

          -  Nonambulatory or requiring the use of crutches, a walker, or more than 1 cane.

          -  Body mass index (BMI) >40.
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