A Study of Duloxetine in Participants With Chronic Pain Due to Osteoarthritis in China
Condition: Osteoarthritis
MeSH terms: Osteoarthritis; Chronic Pain
Intervention: Duloxetine; Placebo
Intervention description: Administered orally; Administered orally
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: 407.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the efficacy and safety of duloxetine once daily
      compared with placebo on the reduction of pain due to osteoarthritis (OA) in knee or hip in
      participants in China.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meet clinical and radiographic criteria for the diagnosis of OA of the knee or hip
             with pain for ≥14 days of each month for 3 months prior to study entry

          -  Have a rating ≥4 on the Brief Pain Inventory (BPI) 24-hour average pain item (Question
             3 of the BPI modified short form) at both Screening and Randomization

        Exclusion Criteria:

          -  Have previously completed/withdrawn from this study or any other study investigating
             duloxetine (Note: Participants who have been previously screened for a duloxetine
             study other than this study and never received investigational product will be
             eligible for this study if they meet all current entry criteria)

          -  Have had previous exposure to duloxetine

          -  Have any previous diagnosis of psychosis, bipolar disorder, or schizoaffective
             disorder

          -  Current (within 1 year of Screening) Diagnostic and Statistical Manual of Mental
             Disorders, Fourth Edition Axis I diagnosis of major depressive disorder, anxiety
             disorders (excluding phobias), alcohol or eating disorders, as determined by the
             Mini-International Neuropsychiatric Interview or a previous diagnosis

          -  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

          -  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 investigational product

          -  Have a positive urine drug screen for any substance of abuse or excluded medication

          -  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 clinically by the investigator to be at suicidal risk according to the
             Columbia - Suicide Severity Rating Scale (C-SSRS): a "Yes" answer to either Question 4
             (Active Suicidal Ideation with Some Intent to Act, Without Specific Plan) or Question
             5 (Active Suicidal Ideation with Specific Plan and Intent) on the"Suicidal Ideation"
             portion of the C-SSRS or a "Yes" answer to any of the suicide related behaviors
             (actual attempt, interrupted attempt, aborted attempt, preparatory act or behavior) on
             the "Suicidal Behavior" portion of the C-SSRS, with the ideation/behavior having
             occurred within the previous month

          -  Have uncontrolled narrow-angle glaucoma

          -  Have acute liver injury (such as hepatitis) or severe cirrhosis

          -  Have known hypersensitivity to duloxetine or any of the inactive ingredients or have
             frequent/severe allergic reactions to multiple medications

          -  Have frequent falls that could result in hospitalization or could compromise response
             to treatment

          -  Have a diagnosis of inflammatory arthritis [that is, rheumatoid arthritis (RA)] or an
             autoimmune disorder (excluding inactive Hashimoto's thyroiditis)

          -  Have received intra-articular hyaluronate/steroids, joint lavage, or other invasive
             therapies to the index joint in the previous 3 months

          -  Have had arthroscopy of the index joint within the previous year or joint replacement
             of the index joint at any time

          -  Have surgery of the index joint scheduled to occur during the trial or are anticipated
             by the investigator to require surgery for the treatment of the OA of the index hip or
             knee along the duration of the study

          -  Have had a prior synovial fluid analysis showing a white blood cell (WBC) count ≥2000
             cubic millimeter (mm3) that is indicative of a diagnosis other than OA

          -  Are non-ambulatory or require the use of crutches or a walker

          -  Have a body mass index >40

          -  Are anticipated by the investigator to require use of analgesic agents including, but
             not limited to, nonsteroidal anti-inflammatory drugs (NSAIDs),
             acetaminophen/paracetamol, and opioids, or other excluded medication for the duration
             of the study