| Criteria: |
|
Inclusion Criteria:
- Present with knee pain due to 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 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 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 mm3 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. |