A Study of Duloxetine in Patients With Osteoarthritis Knee Pain
Condition: Osteoarthritis Knee Pain
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Intervention: Duloxetine (DLX); Placebo (PLA)
Intervention description: dose daily by mouth; Placebo Comparator daily by mouth
Intervention MeSH terms: Duloxetine Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 424.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Osteoarthritis, Knee; Pain

Summary:

      The primary purpose of this study is to determine if duloxetine 60 mg once daily (QD) reduces
      pain severity in patients with osteoarthritis (OA) knee pain compared with placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female outpatients with osteoarthritis knee pain for greater than or equal to
             14 days of each month for 3 months prior to study entry.

          -  Have a rating of greater than or equal to 4 on the BPI average pain item (Question 3
             of the Brief Pain Inventory [BPI] modified short form) at screening and randomization

        Exclusion Criteria:

          -  Have had any previous exposure to duloxetine.

          -  Have any previous diagnosis of psychosis, bipolar disorder, or schizoaffective
             disorder.

          -  Have Major Depression Disorder as defined by the Diagnostic and Statistical Manual of
             Mental Disorders, Fourth Edition, as assessed by the Mini International
             Neuropsychiatric Interview (Sheehan et al. 1998), or diagnosed within the past year.

          -  Have a history of substance abuse or dependence within the past year, excluding
             nicotine and caffeine.

          -  Are taking any excluded medications that cannot be discontinued at screening visit.

          -  Have current or pending disability compensation or litigation issues that may
             compromise response to treatment, in the opinion of the investigator.

          -  Have had treatment with a monoamine oxidase inhibitor (MAOI) within 14 days of
             randomization or the potential need to use an MAOI during the study or within 5 days
             of discontinuation of study drug.

          -  Have a positive urine drug screen for any substance of abuse or excluded medication.

          -  Are pregnant or breast-feeding.

          -  Have serious cardiovascular, hepatic, renal, respiratory, or hematologic illness, or
             other medical or psychiatric condition that, in the opinion of the investigator, would
             compromise participation or be likely to lead to hospitalization during the course of
             the study.

          -  Have a history of recurrent seizures other than febrile seizures.

          -  Are judged by the investigator to be at suicidal risk.

          -  Have uncontrolled narrow-angle glaucoma.

          -  Have acute liver injury (such as hepatitis) or severe cirrhosis (Child- Pugh Class C).

          -  Have known hypersensitivity to duloxetine or any of the inactive ingredients or
             patients with frequent or severe allergic reactions to multiple medications.

          -  Have frequent falls that could result in hospitalization or could compromise response
             to treatment.

          -  Have a confounding painful condition that may interfere with assessment of the index
             joint, that is, knee. (Knee pain should be the predominant pain. Mild OA pain of other
             joints is allowed.)

          -  Have a diagnosis of inflammatory arthritis (that is, rheumatoid arthritis) or an
             autoimmune disorder (excluding inactive Hashimoto's thyroiditis).

          -  Have received intraarticular hyaluronate or steroids, joint lavage, or other invasive
             therapies to the knee in the past 3 months.

          -  Have had knee arthroscopy of the index knee within the past year or joint replacement
             of the index knee at anytime.

          -  Have surgery planned during the study for the index joint.

          -  Have a body mass index (BMI) over 40.

          -  Use of acupuncture, chiropractic maneuvers, transcutaneous electrical nerve
             stimulation (TENS), or similar procedures aimed to relieve any kind of pain.

          -  Patients who are anticipated by the investigator to require use of analgesic agents
             including but not limited to non-steroidal anti-inflammatory drugs(NSAIDs),
             acetaminophen/paracetamol, and opioids, or other excluded medication for the duration
             of the study.

          -  Are unwilling or unable to comply with the data collection method used to record their
             patient rated outcome data.