A Study of Duloxetine (LY248686) in Participants With Chronic Osteoarthritis and Knee Pain in Japan
Condition: Osteoarthritis of the Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
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: 354.0
Sex: All
Minimum age: 40 Years
Maximum age: 79 Years
Healthy volunteers: No

Summary:

      The main purpose of this study is to evaluate the efficacy of the study drug known as
      duloxetine in participants with chronic osteoarthritis (OA) and knee pain in Japan.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants with present OA.

          -  Have pain for ≥ 14 days of each month for 3 months prior to study entry.

          -  Participants must have a score of ≥4 on the BPI average pain score before
             randomization.

          -  Females of child-bearing potential must test negative (-) on a pregnancy test.

        Exclusion Criteria:

          -  Participants who cannot appropriately complete the daily diaries.

          -  Have a score change of ≧3 on BPI 24-hour average pain score between screening and
             baseline.

          -  Participants who have serious cardiovascular, hepatic, renal, endocrine, respiratory,
             or hematologic illness, peripheral vascular disease, or other medical condition or
             neuropsychiatric conditions or clinically significant laboratory abnormalities or
             electrocardiographic abnormalities.

          -  Participants who have alanine aminotransferase (ALT) or aspartate aminotransferase
             (AST) higher than 100 international units per liter (IU/L) or total bilirubin higher
             than 1.6 milligrams/deciliter (mg/dL).

          -  Participants who have serum creatinine level higher than 2.0 mg/dL, or had renal
             transplantation or are receiving renal dialysis.

          -  Participants who have a diagnosis of inflammatory arthritis (that is, rheumatoid
             arthritis) or an autoimmune disorder (excluding inactive Hashimoto's thyroiditis and
             Type 1 diabetes).

          -  Participants who have any previous diagnosis of psychosis, bipolar disorder, or
             schizoaffective disorder.

          -  Participants who have major depressive disorder as determined using depression module
             of the Mini-International Neuropsychiatric Interview (M.I.N.I.).

          -  Participants who have uncorrected thyroid disease, uncontrolled narrow-angle glaucoma,
             history of uncontrolled seizures, or uncontrolled or poorly controlled hypertension.

          -  Participants who have received intrarticular hyaluronate or steroids, joint lavage, or
             other invasive therapies to the knee in the past 1 month.

          -  Participants who have had knee arthroscopy of the index knee within the past year or
             joint replacement of the index knee or osteotomy at anytime.

          -  Participants who have end-stage osteoarthritis or surgery planned during the trial for
             the index joint.

          -  Participants have a prior synovial fluid analysis showing a white blood cell (WBC)
             ≥2000 cubic millimeters (mm3) that is indicative of a diagnosis other than OA.

          -  Participants taking any excluded medications that cannot be discontinued.

          -  Participants anticipated by the investigator to require use of nonsteroidal
             anti-inflammatory drugs that include acetaminophen, opioid analgesics, or other
             excluded medication for the duration of the study.

          -  Participants treated with a monoamine oxidase inhibitor (MAoI) within 14 days prior to
             baseline, or those with the potential need to use MAO inhibitor during the study or
             within 5 days of discontinuation of investigational drug.

          -  Participants who answer 'yes' to any of the questions about active suicidal
             ideation/intent/behaviors occurring within the past month (Columbia-Suicide Severity
             Rating Scale, suicide ideation section-questions 4 and 5; suicidal behaviors section).

          -  Participants who have a history of having more than one medical allergy.

          -  Are non-ambulatory or require the use of crutches or a walker.

          -  Have frequent falls that could result in hospitalization or could compromise response
             to treatment.

          -  Have a primary painful condition that may interfere with assessment of the index
             joint, i.e., knee.

          -  Have a history of drug abuse or dependence within the past year, including alcohol and
             excluding nicotine and caffeine.

          -  Have a positive urine drug screen for any substances of abuse or excluded medication.

          -  Have received administration of another investigational drug within the 30 days prior
             to screening.

          -  Have had previous exposure to duloxetine or completed/withdrawn from any study
             investigating duloxetine.

          -  Pregnant participants, female participants who wish to be pregnant during the clinical
             study period, or participants who are breast-feeding; or male participants who wish
             pregnancy of the partner.