<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02248480</url>
  </required_header>
  <id_info>
    <org_study_id>14375</org_study_id>
    <secondary_id>F1J-JE-HMGX</secondary_id>
    <nct_id>NCT02248480</nct_id>
  </id_info>
  <brief_title>A Study of Duloxetine (LY248686) in Participants With Chronic Osteoarthritis and Knee Pain in Japan</brief_title>
  <official_title>Effect of Duloxetine 60 mg Versus Placebo in Patients With Chronic Osteoarthritis and Knee Pain in Japan</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eli Lilly and Company</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Shionogi</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Eli Lilly and Company</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main purpose of this study is to evaluate the efficacy of the study drug known as&#xD;
      duloxetine in participants with chronic osteoarthritis (OA) and knee pain in Japan.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">June 2015</completion_date>
  <primary_completion_date type="Actual">June 2015</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline on the Brief Pain Inventory (BPI) 24-Hour Average Pain Score</measure>
    <time_frame>Baseline, Week 14</time_frame>
    <description>Brief Pain Inventory Severity: Average Pain Score: A self-reported scale that measures the severity of pain based on the average pain experienced during the past 24-hours. The severity scores ranged from 0 (no pain) to 10 (pain as severe as you can imagine). Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach including administration groups, observation points, and interaction between the administration groups and observation points as fixed effects, and BPI average pain severity at baseline as covariates.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Patient Global Impression of Improvement (PGI-Improvement)</measure>
    <time_frame>Baseline, 14 Weeks</time_frame>
    <description>Patient's Global Impressions of Improvement Scale: PGI-I measures a participant's perception of improvement at the time of assessment compared with the start of treatment. Score ranges from 1 (very much better) to 7 (very much worse). Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach including administration groups, observation points, and interaction between the administration groups and observation points as fixed effects, and PGI-severity at baseline as covariates.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline on the Clinical Global Impression of Severity (CGI-S)</measure>
    <time_frame>Baseline, Week 14</time_frame>
    <description>CSI-S measures severity of illness at the time of assessment compared with start of treatment with scores ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach including administration groups, observation points, and interaction between the administration groups and observation points as fixed effects, and baseline data as covariates.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline on the 36-Item Short-Form Health Survey (SF-36)</measure>
    <time_frame>Baseline, Week 14</time_frame>
    <description>36-item Short-Form Health Survey: SF-36 Health Status Survey is a generic, health-related scale assessing participant's quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health. Domain scores: general health (range: 5-25); physical functioning (range: 10-30); role-physical (range: 4-8); role-emotional (range: 3-15); social functioning (range: 2-10); bodily pain (range: 2-12); vitality (range: 4-20); mental health (range: 5-25). Each raw scale score was converted to a scale score ranging from 0-100 points, , with higher values representing a better outcome [(Raw score) - min{raw score}] / (max {raw score} - min{raw score}) x 100]. Least squares (LS) mean was calculated using Analysis of covariance (ANCOVA) approach including administration groups as fixed effects, and baseline data as covariate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline on the Beck Depression Inventory (BDI-II) Total Score</measure>
    <time_frame>Baseline, Week 14</time_frame>
    <description>Beck Depression Inventory-II: BDI-II is a 21-item, participant-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to symptoms of depression were scored on a 4-point scale ranging from 0 to 3 and was summed to give a single score. A total score of 0-13 was considered minimal range, 14-19 was mild, 20-28 was moderate, and 29-63 was severe. Least squares (LS) mean was calculated using a ANCOVA approach' including administration groups as fixed effects, and baseline data as covariate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Fall Events From Fall Questionnaire</measure>
    <time_frame>Baseline through Week 14</time_frame>
    <description>Participants evaluated their experience with and details of falls which were recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline on the Western Ontario and McMaster Osteoarthritis Index (WOMAC) Questionnaire Total Score</measure>
    <time_frame>Baseline, Week 14</time_frame>
    <description>The 24-question WOMAC Osteoarthritis Index assesses osteoarthritis symptoms using pain (5 questions), stiffness (2 questions) and physical function (17 questions) subscales. The WOMAC Osteoarthritis Index version 3.1 was administered according to the study schedule. The WOMAC total score was calculated for each participant at each time point for analysis as the mean total score, range 0 (none) -96 (extreme). Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach including administration groups, observation points, and interaction between the administration groups and observation points as fixed effects, and baseline data as covariates.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline on the Patient Global Assessment Illness (PGAI) Score</measure>
    <time_frame>Baseline, Week 14</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline on the 5 Dimension (EQ-5D) Version of the European Quality of Life Instrument</measure>
    <time_frame>Baseline, Week 14</time_frame>
    <description>The EQ-5D is a generic, multidimensional, health-related, quality-of-life instrument and was completed on five dimensions (mobility, self care, usual activities, pain/discomfort and anxiety/depression) to measure health-related quality of life on a scale from 0-1, with the higher score indicating a better health state perceived by the participant. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood using a three level scale (no problem, some problems, and major problems). These combinations of attributes were converted into a weighted health-state Index Score according to the Japan population-based algorithm. Least squares (LS) mean was calculated using an ANCOVA approach including administration groups as fixed effects, and baseline data as covariate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Baseline in Brief Pain Inventory Severity and Interference Scores (BPI-S, BPI-I) Change From Baseline in BPI Pain Severity Items and Interference Items Score</measure>
    <time_frame>Baseline, Week 14</time_frame>
    <description>BPI-S and BPI-I are self-reported scales measuring severity of pain and interference on function. Severity scores: 0 (no pain) to 10 (severe pain) on each question assessing worst pain, least pain, and average pain in past 24 hours, and pain right now. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference = average of non-missing scores of individual interference items. Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach including administration groups, observation points, and interaction between the administration groups and observation points as fixed effects, and baseline data as covariates.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With a 30% and 50% Reduction in Average Pain Score on Weekly Mean of the 24-Hour Average Pain Score on the 11-Point Numeric Rating Scale</measure>
    <time_frame>Baseline,Week 14</time_frame>
    <description>24-hour average pain severity scores were recorded daily on an 11-point Likert scale, an ordinal scale, with scores ranging from 0 (no pain) to 10 (worst possible pain). The 11-point Likert scale was also used for assessment of average pain within 24-hours.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline on Weekly Mean of the 24-Hour Average Pain and Worst Pain Score</measure>
    <time_frame>Baseline, Week 14</time_frame>
    <description>24-hour average pain severity scores were recorded daily on an 11-point Likert scale, an ordinal scale, with scores ranging from 0 (no pain) to 10 (worst possible pain). The 11-point Likert scale was also used for assessment of average pain and worst pain within 24-hours. Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach including administration groups, observation points, and interaction between the administration groups and observation points as fixed effects, and baseline data as covariates.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Reduction of ≥30% and ≥50% in BPI Average Pain Score</measure>
    <time_frame>Baseline, Week 14</time_frame>
    <description>Brief Pain Inventory Severity: Average Pain Score: A self-reported scale that measures the severity of pain based on the average pain experienced during the past 24-hours. The severity scores ranged from 0 (no pain) to 10 (pain as severe as you can imagine).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With a Responder Rate Based on OMERACT-OARSI Criteria</measure>
    <time_frame>Baseline, Week 14</time_frame>
    <description>A responder is required to meet at least one condition: reduction of ≥50% and ≥2 score in Weekly Mean of the 24-Hour Average Pain Score, reduction of ≥50% or ≥13.6 score in WOMAC (difficulty in dairy activity) and meet ≥2 out of following 3 conditions: reduction of ≥20% and ≥1 score in Weekly Mean of the 24-Hour Average Pain, reduction of ≥20% and ≥6.8 score in WOMAC (difficulty in dairy activity), PGAI score ≥2.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline on the WOMAC Questionnaire Pain Subscale</measure>
    <time_frame>Baseline, 14 Weeks</time_frame>
    <description>The WOMAC index (pain, stiffness, physical function subscales) was completed by the participant.The pain subscale had 5 questions on pain associated with every day tasks. Each question was answered using a 5-point Likert scale (0 to 4). The pain subscale has a range of scores of 0 (none) to 20 (extreme). Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach including administration groups, observation points, and interaction between the administration groups and observation points as fixed effects, baseline data as covariates.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline on the WOMAC Questionnaire Stiffness Subscale</measure>
    <time_frame>Baseline, 14 Weeks</time_frame>
    <description>The WOMAC index (pain, stiffness, physical function subscales) will be completed by the participant.The stiffness subscale had 2 questions on stiffness associated with time of day (morning versus later in the day). Each question was answered using a 5-point Likert scale (0 to 4). The stiffness subscale has a range of scores of 0 (none) to 8 (extreme). Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach including administration groups, observation points, and interaction between the administration groups and observation points as fixed effects, baseline data as covariates.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline on the WOMAC Questionnaire Physical Function Subscale</measure>
    <time_frame>Baseline, 14 Weeks</time_frame>
    <description>The WOMAC osteoarthritis scale consists of 24 items in 3 subscales: pain, stiffness, and physical function. The physical function subscale rates participant pain during stair use, rising from sitting, standing, bending, walking, getting in/out of a car, shopping, putting on/taking off socks, rising from bed, lying in bed, getting in/out of the bath, sitting, getting on/off the toilet, heavy household duties, and light household duties. Each question was answered using a 5-point Likert scale (0 to 4). Physical Function Subscale has a range of scores of 0 (none) to 68 (extreme). Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach including administration groups, observation points, and interaction between the administration groups and observation points as fixed effects, baseline data as covariates.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">354</enrollment>
  <condition>Osteoarthritis of the Knee</condition>
  <arm_group>
    <arm_group_label>Duloxetine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo administered orally once a day for 15 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Duloxetine</intervention_name>
    <description>Administered orally</description>
    <arm_group_label>Duloxetine</arm_group_label>
    <other_name>LY248686</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Administered orally</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants with present OA.&#xD;
&#xD;
          -  Have pain for ≥ 14 days of each month for 3 months prior to study entry.&#xD;
&#xD;
          -  Participants must have a score of ≥4 on the BPI average pain score before&#xD;
             randomization.&#xD;
&#xD;
          -  Females of child-bearing potential must test negative (-) on a pregnancy test.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants who cannot appropriately complete the daily diaries.&#xD;
&#xD;
          -  Have a score change of ≧3 on BPI 24-hour average pain score between screening and&#xD;
             baseline.&#xD;
&#xD;
          -  Participants who have serious cardiovascular, hepatic, renal, endocrine, respiratory,&#xD;
             or hematologic illness, peripheral vascular disease, or other medical condition or&#xD;
             neuropsychiatric conditions or clinically significant laboratory abnormalities or&#xD;
             electrocardiographic abnormalities.&#xD;
&#xD;
          -  Participants who have alanine aminotransferase (ALT) or aspartate aminotransferase&#xD;
             (AST) higher than 100 international units per liter (IU/L) or total bilirubin higher&#xD;
             than 1.6 milligrams/deciliter (mg/dL).&#xD;
&#xD;
          -  Participants who have serum creatinine level higher than 2.0 mg/dL, or had renal&#xD;
             transplantation or are receiving renal dialysis.&#xD;
&#xD;
          -  Participants who have a diagnosis of inflammatory arthritis (that is, rheumatoid&#xD;
             arthritis) or an autoimmune disorder (excluding inactive Hashimoto's thyroiditis and&#xD;
             Type 1 diabetes).&#xD;
&#xD;
          -  Participants who have any previous diagnosis of psychosis, bipolar disorder, or&#xD;
             schizoaffective disorder.&#xD;
&#xD;
          -  Participants who have major depressive disorder as determined using depression module&#xD;
             of the Mini-International Neuropsychiatric Interview (M.I.N.I.).&#xD;
&#xD;
          -  Participants who have uncorrected thyroid disease, uncontrolled narrow-angle glaucoma,&#xD;
             history of uncontrolled seizures, or uncontrolled or poorly controlled hypertension.&#xD;
&#xD;
          -  Participants who have received intrarticular hyaluronate or steroids, joint lavage, or&#xD;
             other invasive therapies to the knee in the past 1 month.&#xD;
&#xD;
          -  Participants who have had knee arthroscopy of the index knee within the past year or&#xD;
             joint replacement of the index knee or osteotomy at anytime.&#xD;
&#xD;
          -  Participants who have end-stage osteoarthritis or surgery planned during the trial for&#xD;
             the index joint.&#xD;
&#xD;
          -  Participants have a prior synovial fluid analysis showing a white blood cell (WBC)&#xD;
             ≥2000 cubic millimeters (mm3) that is indicative of a diagnosis other than OA.&#xD;
&#xD;
          -  Participants taking any excluded medications that cannot be discontinued.&#xD;
&#xD;
          -  Participants anticipated by the investigator to require use of nonsteroidal&#xD;
             anti-inflammatory drugs that include acetaminophen, opioid analgesics, or other&#xD;
             excluded medication for the duration of the study.&#xD;
&#xD;
          -  Participants treated with a monoamine oxidase inhibitor (MAoI) within 14 days prior to&#xD;
             baseline, or those with the potential need to use MAO inhibitor during the study or&#xD;
             within 5 days of discontinuation of investigational drug.&#xD;
&#xD;
          -  Participants who answer 'yes' to any of the questions about active suicidal&#xD;
             ideation/intent/behaviors occurring within the past month (Columbia-Suicide Severity&#xD;
             Rating Scale, suicide ideation section-questions 4 and 5; suicidal behaviors section).&#xD;
&#xD;
          -  Participants who have a history of having more than one medical allergy.&#xD;
&#xD;
          -  Are non-ambulatory or require the use of crutches or a walker.&#xD;
&#xD;
          -  Have frequent falls that could result in hospitalization or could compromise response&#xD;
             to treatment.&#xD;
&#xD;
          -  Have a primary painful condition that may interfere with assessment of the index&#xD;
             joint, i.e., knee.&#xD;
&#xD;
          -  Have a history of drug abuse or dependence within the past year, including alcohol and&#xD;
             excluding nicotine and caffeine.&#xD;
&#xD;
          -  Have a positive urine drug screen for any substances of abuse or excluded medication.&#xD;
&#xD;
          -  Have received administration of another investigational drug within the 30 days prior&#xD;
             to screening.&#xD;
&#xD;
          -  Have had previous exposure to duloxetine or completed/withdrawn from any study&#xD;
             investigating duloxetine.&#xD;
&#xD;
          -  Pregnant participants, female participants who wish to be pregnant during the clinical&#xD;
             study period, or participants who are breast-feeding; or male participants who wish&#xD;
             pregnancy of the partner.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>79 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)</last_name>
    <role>Study Director</role>
    <affiliation>Eli Lilly and Company</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Hyogo</city>
        <zip>651-0086</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>September 22, 2014</study_first_submitted>
  <study_first_submitted_qc>September 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <results_first_submitted>June 15, 2016</results_first_submitted>
  <results_first_submitted_qc>November 22, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">January 16, 2017</results_first_posted>
  <last_update_submitted>September 10, 2019</last_update_submitted>
  <last_update_submitted_qc>September 10, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 26, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Osteoarthritis, Knee</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Duloxetine Hydrochloride</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.</ipd_time_frame>
    <ipd_access_criteria>A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.</ipd_access_criteria>
    <ipd_url>https://vivli.org/</ipd_url>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>All started participants (pt) were randomized and received at least one dose of study drug. Efficacy population had at least 1 post-dose efficacy assessment.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Duloxetine</title>
          <description>Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>Placebo administered orally once a day for 15 weeks.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="178"/>
                <participants group_id="P2" count="176"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Efficacy Population</title>
              <participants_list>
                <participants group_id="P1" count="177"/>
                <participants group_id="P2" count="176"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="161"/>
                <participants group_id="P2" count="162"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="17"/>
                <participants group_id="P2" count="14"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Entry Criteria Not Met</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other:Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Al randomized participants who received at least 1 dose of study drug and had 1 post-dose efficacy assessment.</population>
      <group_list>
        <group group_id="B1">
          <title>Duloxetine</title>
          <description>Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>Placebo administered orally once a day for 15 weeks.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="177"/>
            <count group_id="B2" value="176"/>
            <count group_id="B3" value="353"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="65.5" spread="8.0"/>
                    <measurement group_id="B2" value="66.4" spread="8.4"/>
                    <measurement group_id="B3" value="65.9" spread="8.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="142"/>
                    <measurement group_id="B2" value="132"/>
                    <measurement group_id="B3" value="274"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                    <measurement group_id="B2" value="44"/>
                    <measurement group_id="B3" value="79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="177"/>
                    <measurement group_id="B2" value="176"/>
                    <measurement group_id="B3" value="353"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Japan</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="177"/>
                    <measurement group_id="B2" value="176"/>
                    <measurement group_id="B3" value="353"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline on the Brief Pain Inventory (BPI) 24-Hour Average Pain Score</title>
        <description>Brief Pain Inventory Severity: Average Pain Score: A self-reported scale that measures the severity of pain based on the average pain experienced during the past 24-hours. The severity scores ranged from 0 (no pain) to 10 (pain as severe as you can imagine). Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach including administration groups, observation points, and interaction between the administration groups and observation points as fixed effects, and BPI average pain severity at baseline as covariates.</description>
        <time_frame>Baseline, Week 14</time_frame>
        <population>All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Duloxetine</title>
            <description>Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo administered orally once a day for 15 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline on the Brief Pain Inventory (BPI) 24-Hour Average Pain Score</title>
          <description>Brief Pain Inventory Severity: Average Pain Score: A self-reported scale that measures the severity of pain based on the average pain experienced during the past 24-hours. The severity scores ranged from 0 (no pain) to 10 (pain as severe as you can imagine). Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach including administration groups, observation points, and interaction between the administration groups and observation points as fixed effects, and BPI average pain severity at baseline as covariates.</description>
          <population>All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="177"/>
                <count group_id="O2" value="176"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.57" spread="0.12"/>
                    <measurement group_id="O2" value="-1.80" spread="0.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>&lt;.0001</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Patient Global Impression of Improvement (PGI-Improvement)</title>
        <description>Patient's Global Impressions of Improvement Scale: PGI-I measures a participant's perception of improvement at the time of assessment compared with the start of treatment. Score ranges from 1 (very much better) to 7 (very much worse). Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach including administration groups, observation points, and interaction between the administration groups and observation points as fixed effects, and PGI-severity at baseline as covariates.</description>
        <time_frame>Baseline, 14 Weeks</time_frame>
        <population>All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Duloxetine</title>
            <description>Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo administered orally once a day for 15 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Patient Global Impression of Improvement (PGI-Improvement)</title>
          <description>Patient's Global Impressions of Improvement Scale: PGI-I measures a participant's perception of improvement at the time of assessment compared with the start of treatment. Score ranges from 1 (very much better) to 7 (very much worse). Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach including administration groups, observation points, and interaction between the administration groups and observation points as fixed effects, and PGI-severity at baseline as covariates.</description>
          <population>All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="177"/>
                <count group_id="O2" value="176"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.23" spread="0.09"/>
                    <measurement group_id="O2" value="2.84" spread="0.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline on the Clinical Global Impression of Severity (CGI-S)</title>
        <description>CSI-S measures severity of illness at the time of assessment compared with start of treatment with scores ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach including administration groups, observation points, and interaction between the administration groups and observation points as fixed effects, and baseline data as covariates.</description>
        <time_frame>Baseline, Week 14</time_frame>
        <population>All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Duloxetine</title>
            <description>Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo administered orally once a day for 15 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline on the Clinical Global Impression of Severity (CGI-S)</title>
          <description>CSI-S measures severity of illness at the time of assessment compared with start of treatment with scores ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach including administration groups, observation points, and interaction between the administration groups and observation points as fixed effects, and baseline data as covariates.</description>
          <population>All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="177"/>
                <count group_id="O2" value="176"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.71" spread="0.07"/>
                    <measurement group_id="O2" value="-1.22" spread="0.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline on the 36-Item Short-Form Health Survey (SF-36)</title>
        <description>36-item Short-Form Health Survey: SF-36 Health Status Survey is a generic, health-related scale assessing participant's quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health. Domain scores: general health (range: 5-25); physical functioning (range: 10-30); role-physical (range: 4-8); role-emotional (range: 3-15); social functioning (range: 2-10); bodily pain (range: 2-12); vitality (range: 4-20); mental health (range: 5-25). Each raw scale score was converted to a scale score ranging from 0-100 points, , with higher values representing a better outcome [(Raw score) - min{raw score}] / (max {raw score} - min{raw score}) x 100]. Least squares (LS) mean was calculated using Analysis of covariance (ANCOVA) approach including administration groups as fixed effects, and baseline data as covariate.</description>
        <time_frame>Baseline, Week 14</time_frame>
        <population>All participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment. The last observation carried forward (LOCF) was used.</population>
        <group_list>
          <group group_id="O1">
            <title>Duloxetine</title>
            <description>Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo administered orally once a day for 15 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline on the 36-Item Short-Form Health Survey (SF-36)</title>
          <description>36-item Short-Form Health Survey: SF-36 Health Status Survey is a generic, health-related scale assessing participant's quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health. Domain scores: general health (range: 5-25); physical functioning (range: 10-30); role-physical (range: 4-8); role-emotional (range: 3-15); social functioning (range: 2-10); bodily pain (range: 2-12); vitality (range: 4-20); mental health (range: 5-25). Each raw scale score was converted to a scale score ranging from 0-100 points, , with higher values representing a better outcome [(Raw score) - min{raw score}] / (max {raw score} - min{raw score}) x 100]. Least squares (LS) mean was calculated using Analysis of covariance (ANCOVA) approach including administration groups as fixed effects, and baseline data as covariate.</description>
          <population>All participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment. The last observation carried forward (LOCF) was used.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="177"/>
                <count group_id="O2" value="176"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Physical Functioning</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.62" spread="1.27"/>
                    <measurement group_id="O2" value="6.23" spread="1.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Role (Physical)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.44" spread="1.29"/>
                    <measurement group_id="O2" value="3.66" spread="1.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bodily Pain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.32" spread="1.22"/>
                    <measurement group_id="O2" value="9.63" spread="1.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>General Health</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.58" spread="0.93"/>
                    <measurement group_id="O2" value="1.82" spread="0.94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vitality</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.99" spread="1.04"/>
                    <measurement group_id="O2" value="3.16" spread="1.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Social Functioning</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.66" spread="1.14"/>
                    <measurement group_id="O2" value="2.54" spread="1.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Role (Emotional)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.32" spread="1.27"/>
                    <measurement group_id="O2" value="0.70" spread="1.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mental Health</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.02" spread="0.99"/>
                    <measurement group_id="O2" value="1.48" spread="0.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline on the Beck Depression Inventory (BDI-II) Total Score</title>
        <description>Beck Depression Inventory-II: BDI-II is a 21-item, participant-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to symptoms of depression were scored on a 4-point scale ranging from 0 to 3 and was summed to give a single score. A total score of 0-13 was considered minimal range, 14-19 was mild, 20-28 was moderate, and 29-63 was severe. Least squares (LS) mean was calculated using a ANCOVA approach' including administration groups as fixed effects, and baseline data as covariate.</description>
        <time_frame>Baseline, Week 14</time_frame>
        <population>All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment. The last observation carried forward (LOCF) was used.</population>
        <group_list>
          <group group_id="O1">
            <title>Duloxetine</title>
            <description>Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo administered orally once a day for 15 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline on the Beck Depression Inventory (BDI-II) Total Score</title>
          <description>Beck Depression Inventory-II: BDI-II is a 21-item, participant-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to symptoms of depression were scored on a 4-point scale ranging from 0 to 3 and was summed to give a single score. A total score of 0-13 was considered minimal range, 14-19 was mild, 20-28 was moderate, and 29-63 was severe. Least squares (LS) mean was calculated using a ANCOVA approach' including administration groups as fixed effects, and baseline data as covariate.</description>
          <population>All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment. The last observation carried forward (LOCF) was used.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="177"/>
                <count group_id="O2" value="176"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.78" spread="0.23"/>
                    <measurement group_id="O2" value="-0.51" spread="0.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Fall Events From Fall Questionnaire</title>
        <description>Participants evaluated their experience with and details of falls which were recorded.</description>
        <time_frame>Baseline through Week 14</time_frame>
        <population>All randomized participants who received at least 1 dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Duloxetine</title>
            <description>Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo administered orally once a day for 15 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Fall Events From Fall Questionnaire</title>
          <description>Participants evaluated their experience with and details of falls which were recorded.</description>
          <population>All randomized participants who received at least 1 dose of study drug.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="178"/>
                <count group_id="O2" value="176"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.1"/>
                    <measurement group_id="O2" value="9.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline on the Western Ontario and McMaster Osteoarthritis Index (WOMAC) Questionnaire Total Score</title>
        <description>The 24-question WOMAC Osteoarthritis Index assesses osteoarthritis symptoms using pain (5 questions), stiffness (2 questions) and physical function (17 questions) subscales. The WOMAC Osteoarthritis Index version 3.1 was administered according to the study schedule. The WOMAC total score was calculated for each participant at each time point for analysis as the mean total score, range 0 (none) -96 (extreme). Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach including administration groups, observation points, and interaction between the administration groups and observation points as fixed effects, and baseline data as covariates.</description>
        <time_frame>Baseline, Week 14</time_frame>
        <population>All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Duloxetine</title>
            <description>Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo administered orally once a day for 15 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline on the Western Ontario and McMaster Osteoarthritis Index (WOMAC) Questionnaire Total Score</title>
          <description>The 24-question WOMAC Osteoarthritis Index assesses osteoarthritis symptoms using pain (5 questions), stiffness (2 questions) and physical function (17 questions) subscales. The WOMAC Osteoarthritis Index version 3.1 was administered according to the study schedule. The WOMAC total score was calculated for each participant at each time point for analysis as the mean total score, range 0 (none) -96 (extreme). Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach including administration groups, observation points, and interaction between the administration groups and observation points as fixed effects, and baseline data as covariates.</description>
          <population>All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="177"/>
                <count group_id="O2" value="176"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-17.41" spread="0.91"/>
                    <measurement group_id="O2" value="-10.45" spread="0.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline on the Patient Global Assessment Illness (PGAI) Score</title>
        <time_frame>Baseline, Week 14</time_frame>
        <population>Zero participants analyzed. PGAI outcome measure was registered incorrectly thus no analysis produced.</population>
        <group_list>
          <group group_id="O1">
            <title>Duloxetine</title>
            <description>Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.&#xD;
Duloxetine: Administered orally</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo administered orally once a day for 15 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline on the Patient Global Assessment Illness (PGAI) Score</title>
          <population>Zero participants analyzed. PGAI outcome measure was registered incorrectly thus no analysis produced.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline on the 5 Dimension (EQ-5D) Version of the European Quality of Life Instrument</title>
        <description>The EQ-5D is a generic, multidimensional, health-related, quality-of-life instrument and was completed on five dimensions (mobility, self care, usual activities, pain/discomfort and anxiety/depression) to measure health-related quality of life on a scale from 0-1, with the higher score indicating a better health state perceived by the participant. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood using a three level scale (no problem, some problems, and major problems). These combinations of attributes were converted into a weighted health-state Index Score according to the Japan population-based algorithm. Least squares (LS) mean was calculated using an ANCOVA approach including administration groups as fixed effects, and baseline data as covariate.</description>
        <time_frame>Baseline, Week 14</time_frame>
        <population>All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment. The last observation carried forward (LOCF) was used.</population>
        <group_list>
          <group group_id="O1">
            <title>Duloxetine</title>
            <description>Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo administered orally once a day for 15 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline on the 5 Dimension (EQ-5D) Version of the European Quality of Life Instrument</title>
          <description>The EQ-5D is a generic, multidimensional, health-related, quality-of-life instrument and was completed on five dimensions (mobility, self care, usual activities, pain/discomfort and anxiety/depression) to measure health-related quality of life on a scale from 0-1, with the higher score indicating a better health state perceived by the participant. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood using a three level scale (no problem, some problems, and major problems). These combinations of attributes were converted into a weighted health-state Index Score according to the Japan population-based algorithm. Least squares (LS) mean was calculated using an ANCOVA approach including administration groups as fixed effects, and baseline data as covariate.</description>
          <population>All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment. The last observation carried forward (LOCF) was used.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="177"/>
                <count group_id="O2" value="176"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.12" spread="0.01"/>
                    <measurement group_id="O2" value="0.07" spread="0.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Baseline in Brief Pain Inventory Severity and Interference Scores (BPI-S, BPI-I) Change From Baseline in BPI Pain Severity Items and Interference Items Score</title>
        <description>BPI-S and BPI-I are self-reported scales measuring severity of pain and interference on function. Severity scores: 0 (no pain) to 10 (severe pain) on each question assessing worst pain, least pain, and average pain in past 24 hours, and pain right now. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference = average of non-missing scores of individual interference items. Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach including administration groups, observation points, and interaction between the administration groups and observation points as fixed effects, and baseline data as covariates.</description>
        <time_frame>Baseline, Week 14</time_frame>
        <population>All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Duloxetine</title>
            <description>Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo administered orally once a day for 15 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Baseline in Brief Pain Inventory Severity and Interference Scores (BPI-S, BPI-I) Change From Baseline in BPI Pain Severity Items and Interference Items Score</title>
          <description>BPI-S and BPI-I are self-reported scales measuring severity of pain and interference on function. Severity scores: 0 (no pain) to 10 (severe pain) on each question assessing worst pain, least pain, and average pain in past 24 hours, and pain right now. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference = average of non-missing scores of individual interference items. Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach including administration groups, observation points, and interaction between the administration groups and observation points as fixed effects, and baseline data as covariates.</description>
          <population>All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="177"/>
                <count group_id="O2" value="176"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Worse Pain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.92" spread="0.15"/>
                    <measurement group_id="O2" value="-2.13" spread="0.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Least Pain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.61" spread="0.11"/>
                    <measurement group_id="O2" value="-1.05" spread="0.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain Right Now</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.29" spread="0.13"/>
                    <measurement group_id="O2" value="-1.52" spread="0.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>General Activity</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.42" spread="0.14"/>
                    <measurement group_id="O2" value="-1.52" spread="0.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Walking Ability</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.58" spread="0.14"/>
                    <measurement group_id="O2" value="-1.74" spread="0.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mood</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.95" spread="0.12"/>
                    <measurement group_id="O2" value="-1.43" spread="0.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Normal Work</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.48" spread="0.13"/>
                    <measurement group_id="O2" value="-1.67" spread="0.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Relationship to People</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.23" spread="0.11"/>
                    <measurement group_id="O2" value="-0.81" spread="0.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sleep</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.65" spread="0.11"/>
                    <measurement group_id="O2" value="-1.19" spread="0.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Enjoyment of Life</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.78" spread="0.12"/>
                    <measurement group_id="O2" value="-1.16" spread="0.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Average of 7 Items</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.01" spread="0.11"/>
                    <measurement group_id="O2" value="-1.34" spread="0.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With a 30% and 50% Reduction in Average Pain Score on Weekly Mean of the 24-Hour Average Pain Score on the 11-Point Numeric Rating Scale</title>
        <description>24-hour average pain severity scores were recorded daily on an 11-point Likert scale, an ordinal scale, with scores ranging from 0 (no pain) to 10 (worst possible pain). The 11-point Likert scale was also used for assessment of average pain within 24-hours.</description>
        <time_frame>Baseline,Week 14</time_frame>
        <population>All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment. The last observation carried forward (LOCF) was used.</population>
        <group_list>
          <group group_id="O1">
            <title>Duloxetine</title>
            <description>Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo administered orally once a day for 15 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With a 30% and 50% Reduction in Average Pain Score on Weekly Mean of the 24-Hour Average Pain Score on the 11-Point Numeric Rating Scale</title>
          <description>24-hour average pain severity scores were recorded daily on an 11-point Likert scale, an ordinal scale, with scores ranging from 0 (no pain) to 10 (worst possible pain). The 11-point Likert scale was also used for assessment of average pain within 24-hours.</description>
          <population>All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment. The last observation carried forward (LOCF) was used.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="177"/>
                <count group_id="O2" value="176"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>&gt;=30%</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72.3"/>
                    <measurement group_id="O2" value="52.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt;=50%</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55.4"/>
                    <measurement group_id="O2" value="38.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline on Weekly Mean of the 24-Hour Average Pain and Worst Pain Score</title>
        <description>24-hour average pain severity scores were recorded daily on an 11-point Likert scale, an ordinal scale, with scores ranging from 0 (no pain) to 10 (worst possible pain). The 11-point Likert scale was also used for assessment of average pain and worst pain within 24-hours. Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach including administration groups, observation points, and interaction between the administration groups and observation points as fixed effects, and baseline data as covariates.</description>
        <time_frame>Baseline, Week 14</time_frame>
        <population>All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Duloxetine</title>
            <description>Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo administered orally once a day for 15 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline on Weekly Mean of the 24-Hour Average Pain and Worst Pain Score</title>
          <description>24-hour average pain severity scores were recorded daily on an 11-point Likert scale, an ordinal scale, with scores ranging from 0 (no pain) to 10 (worst possible pain). The 11-point Likert scale was also used for assessment of average pain and worst pain within 24-hours. Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach including administration groups, observation points, and interaction between the administration groups and observation points as fixed effects, and baseline data as covariates.</description>
          <population>All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="177"/>
                <count group_id="O2" value="176"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Average Pain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.45" spread="0.12"/>
                    <measurement group_id="O2" value="-1.79" spread="0.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Worst Pain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.73" spread="0.14"/>
                    <measurement group_id="O2" value="-1.97" spread="0.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Reduction of ≥30% and ≥50% in BPI Average Pain Score</title>
        <description>Brief Pain Inventory Severity: Average Pain Score: A self-reported scale that measures the severity of pain based on the average pain experienced during the past 24-hours. The severity scores ranged from 0 (no pain) to 10 (pain as severe as you can imagine).</description>
        <time_frame>Baseline, Week 14</time_frame>
        <population>All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment. The last observation carried forward (LOCF) was used.</population>
        <group_list>
          <group group_id="O1">
            <title>Duloxetine</title>
            <description>Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo administered orally once a day for 15 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Reduction of ≥30% and ≥50% in BPI Average Pain Score</title>
          <description>Brief Pain Inventory Severity: Average Pain Score: A self-reported scale that measures the severity of pain based on the average pain experienced during the past 24-hours. The severity scores ranged from 0 (no pain) to 10 (pain as severe as you can imagine).</description>
          <population>All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment. The last observation carried forward (LOCF) was used.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="177"/>
                <count group_id="O2" value="176"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>&gt;=30%</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72.3"/>
                    <measurement group_id="O2" value="52.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt;=50%</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55.4"/>
                    <measurement group_id="O2" value="38.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With a Responder Rate Based on OMERACT-OARSI Criteria</title>
        <description>A responder is required to meet at least one condition: reduction of ≥50% and ≥2 score in Weekly Mean of the 24-Hour Average Pain Score, reduction of ≥50% or ≥13.6 score in WOMAC (difficulty in dairy activity) and meet ≥2 out of following 3 conditions: reduction of ≥20% and ≥1 score in Weekly Mean of the 24-Hour Average Pain, reduction of ≥20% and ≥6.8 score in WOMAC (difficulty in dairy activity), PGAI score ≥2.</description>
        <time_frame>Baseline, Week 14</time_frame>
        <population>All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment. The last observation carried forward (LOCF) was used.</population>
        <group_list>
          <group group_id="O1">
            <title>Duloxetine</title>
            <description>Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo administered orally once a day for 15 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With a Responder Rate Based on OMERACT-OARSI Criteria</title>
          <description>A responder is required to meet at least one condition: reduction of ≥50% and ≥2 score in Weekly Mean of the 24-Hour Average Pain Score, reduction of ≥50% or ≥13.6 score in WOMAC (difficulty in dairy activity) and meet ≥2 out of following 3 conditions: reduction of ≥20% and ≥1 score in Weekly Mean of the 24-Hour Average Pain, reduction of ≥20% and ≥6.8 score in WOMAC (difficulty in dairy activity), PGAI score ≥2.</description>
          <population>All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment. The last observation carried forward (LOCF) was used.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="177"/>
                <count group_id="O2" value="176"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="83.6"/>
                    <measurement group_id="O2" value="61.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline on the WOMAC Questionnaire Pain Subscale</title>
        <description>The WOMAC index (pain, stiffness, physical function subscales) was completed by the participant.The pain subscale had 5 questions on pain associated with every day tasks. Each question was answered using a 5-point Likert scale (0 to 4). The pain subscale has a range of scores of 0 (none) to 20 (extreme). Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach including administration groups, observation points, and interaction between the administration groups and observation points as fixed effects, baseline data as covariates.</description>
        <time_frame>Baseline, 14 Weeks</time_frame>
        <population>All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Duloxetine</title>
            <description>Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo administered orally once a day for 15 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline on the WOMAC Questionnaire Pain Subscale</title>
          <description>The WOMAC index (pain, stiffness, physical function subscales) was completed by the participant.The pain subscale had 5 questions on pain associated with every day tasks. Each question was answered using a 5-point Likert scale (0 to 4). The pain subscale has a range of scores of 0 (none) to 20 (extreme). Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach including administration groups, observation points, and interaction between the administration groups and observation points as fixed effects, baseline data as covariates.</description>
          <population>All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="177"/>
                <count group_id="O2" value="176"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.99" spread="0.21"/>
                    <measurement group_id="O2" value="-2.43" spread="0.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline on the WOMAC Questionnaire Stiffness Subscale</title>
        <description>The WOMAC index (pain, stiffness, physical function subscales) will be completed by the participant.The stiffness subscale had 2 questions on stiffness associated with time of day (morning versus later in the day). Each question was answered using a 5-point Likert scale (0 to 4). The stiffness subscale has a range of scores of 0 (none) to 8 (extreme). Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach including administration groups, observation points, and interaction between the administration groups and observation points as fixed effects, baseline data as covariates.</description>
        <time_frame>Baseline, 14 Weeks</time_frame>
        <population>All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Duloxetine</title>
            <description>Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo administered orally once a day for 15 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline on the WOMAC Questionnaire Stiffness Subscale</title>
          <description>The WOMAC index (pain, stiffness, physical function subscales) will be completed by the participant.The stiffness subscale had 2 questions on stiffness associated with time of day (morning versus later in the day). Each question was answered using a 5-point Likert scale (0 to 4). The stiffness subscale has a range of scores of 0 (none) to 8 (extreme). Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach including administration groups, observation points, and interaction between the administration groups and observation points as fixed effects, baseline data as covariates.</description>
          <population>All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="177"/>
                <count group_id="O2" value="176"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.66" spread="0.09"/>
                    <measurement group_id="O2" value="-0.98" spread="0.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline on the WOMAC Questionnaire Physical Function Subscale</title>
        <description>The WOMAC osteoarthritis scale consists of 24 items in 3 subscales: pain, stiffness, and physical function. The physical function subscale rates participant pain during stair use, rising from sitting, standing, bending, walking, getting in/out of a car, shopping, putting on/taking off socks, rising from bed, lying in bed, getting in/out of the bath, sitting, getting on/off the toilet, heavy household duties, and light household duties. Each question was answered using a 5-point Likert scale (0 to 4). Physical Function Subscale has a range of scores of 0 (none) to 68 (extreme). Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach including administration groups, observation points, and interaction between the administration groups and observation points as fixed effects, baseline data as covariates.</description>
        <time_frame>Baseline, 14 Weeks</time_frame>
        <population>All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Duloxetine</title>
            <description>Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo administered orally once a day for 15 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline on the WOMAC Questionnaire Physical Function Subscale</title>
          <description>The WOMAC osteoarthritis scale consists of 24 items in 3 subscales: pain, stiffness, and physical function. The physical function subscale rates participant pain during stair use, rising from sitting, standing, bending, walking, getting in/out of a car, shopping, putting on/taking off socks, rising from bed, lying in bed, getting in/out of the bath, sitting, getting on/off the toilet, heavy household duties, and light household duties. Each question was answered using a 5-point Likert scale (0 to 4). Physical Function Subscale has a range of scores of 0 (none) to 68 (extreme). Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach including administration groups, observation points, and interaction between the administration groups and observation points as fixed effects, baseline data as covariates.</description>
          <population>All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="177"/>
                <count group_id="O2" value="176"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-11.77" spread="0.67"/>
                    <measurement group_id="O2" value="-7.07" spread="0.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <desc>All randomized participants who received at least 1 dose of study drug.</desc>
      <group_list>
        <group group_id="E1">
          <title>Duloxetine</title>
          <description>Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>Placebo administered orally once a day for 15 weeks.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 17.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="176"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Cerebellar tumour</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Malignant ascites</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="176"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA 17.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="120" subjects_at_risk="178"/>
                <counts group_id="E2" subjects_affected="98" subjects_at_risk="176"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="176"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Ear congestion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Tinnitus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="178"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Vertigo positional</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="176"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Basedow's disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="176"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Blepharitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Dry eye</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Vision blurred</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="176"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal discomfort</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="178"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="178"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="178"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Anal fissure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Cheilitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Colitis ischaemic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="20" subjects_affected="19" subjects_at_risk="178"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Dental caries</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="7" subjects_affected="6" subjects_at_risk="178"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Faeces hard</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="178"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Glossitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="21" subjects_affected="18" subjects_at_risk="178"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="178"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="178"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="176"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Feeling abnormal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" events="12" subjects_affected="12" subjects_at_risk="178"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Peripheral swelling</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Thirst</sub_title>
                <counts group_id="E1" events="19" subjects_affected="19" subjects_at_risk="178"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="176"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Hepatic function abnormal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="176"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Cystitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="178"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Gastroenteritis rotavirus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Gingival abscess</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Gingivitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Hordeolum</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="27" subjects_affected="27" subjects_at_risk="178"/>
                <counts group_id="E2" events="30" subjects_affected="28" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Oral herpes</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Paronychia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Periodontitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Tonsillitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="176"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Chillblains</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Comminuted fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" events="10" subjects_affected="9" subjects_at_risk="178"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Excoriation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Frostbite</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Ligament sprain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="178"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Limb crushing injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Muscle injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Muscle rupture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Patella fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Procedural pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Thermal burn</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="176"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="178"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="178"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Blood creatine phosphokinase increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Blood potassium decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Blood potassium increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Blood uric acid increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Blood urine present</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="178"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Gamma-glutamyltransferase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Liver function test abnormal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>White blood cell count increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="176"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="178"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Diabetes mellitus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="176"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="178"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E2" events="10" subjects_affected="8" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Costochondritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Intervertebral disc protrusion</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="178"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Limb discomfort</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Lumbar spinal stenosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="178"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Myalgia intercostal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Nodal osteoarthritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Osteoporosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Periarthritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Rotator cuff syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Spinal osteoarthritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Synovitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Tenosynovitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Tenosynovitis stenosans</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="176"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Skin papilloma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="176"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Carpal tunnel syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Cerebral infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Cervicobrachial syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="178"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Dizziness postural</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E2" events="11" subjects_affected="5" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Hypoaesthesia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Loss of consciousness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Migraine</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Sciatica</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" events="24" subjects_affected="24" subjects_at_risk="178"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="176"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Abulia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="178"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="176"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Dysuria</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="178"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Hypertonic bladder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Pollakiuria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Stress urinary incontinence</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Urethral haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Urinary incontinence</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Urine flow decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="176"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Rhinitis allergic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract inflammation</sub_title>
                <counts group_id="E1" events="5" subjects_affected="3" subjects_at_risk="178"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="176"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermatitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Dermatitis contact</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="178"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Eczema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Eczema asteatotic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Haemorrhage subcutaneous</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Hyperkeratosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Ingrowing nail</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Prurigo</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Seborrhoeic dermatitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="176"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hot flush</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Orthostatic hypotension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Peripheral arterial occlusive disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Varicose vein</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="176"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Chief Medical Officer</name_or_title>
      <organization>Eli Lilly and Company</organization>
      <phone>800-545-5979</phone>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02248480
org study id: 14375
secondary id: F1J-JE-HMGX
nct id: NCT02248480
lead sponsor: 
collaborator: 
has dmc: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change From Baseline on the Brief Pain Inventory (BPI) 24-Hour Average Pain Score
time frame: Baseline, Week 14
description: Brief Pain Inventory Severity: Average Pain Score: A self-reported scale that measures the severity of pain based on the average pain experienced during the past 24-hours. The severity scores ranged from 0 (no pain) to 10 (pain as severe as you can imagine). Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach including administration groups, observation points, and interaction between the administration groups and observation points as fixed effects, and BPI average pain severity at baseline as covariates.
measure: Change From Baseline in Patient Global Impression of Improvement (PGI-Improvement)
time frame: Baseline, 14 Weeks
description: Patient's Global Impressions of Improvement Scale: PGI-I measures a participant's perception of improvement at the time of assessment compared with the start of treatment. Score ranges from 1 (very much better) to 7 (very much worse). Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach including administration groups, observation points, and interaction between the administration groups and observation points as fixed effects, and PGI-severity at baseline as covariates.
measure: Change From Baseline on the Clinical Global Impression of Severity (CGI-S)
time frame: Baseline, Week 14
description: CSI-S measures severity of illness at the time of assessment compared with start of treatment with scores ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach including administration groups, observation points, and interaction between the administration groups and observation points as fixed effects, and baseline data as covariates.
measure: Change From Baseline on the 36-Item Short-Form Health Survey (SF-36)
time frame: Baseline, Week 14
description: 36-item Short-Form Health Survey: SF-36 Health Status Survey is a generic, health-related scale assessing participant's quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health. Domain scores: general health (range: 5-25); physical functioning (range: 10-30); role-physical (range: 4-8); role-emotional (range: 3-15); social functioning (range: 2-10); bodily pain (range: 2-12); vitality (range: 4-20); mental health (range: 5-25). Each raw scale score was converted to a scale score ranging from 0-100 points, , with higher values representing a better outcome [(Raw score) - min{raw score}] / (max {raw score} - min{raw score}) x 100]. Least squares (LS) mean was calculated using Analysis of covariance (ANCOVA) approach including administration groups as fixed effects, and baseline data as covariate.
measure: Change From Baseline on the Beck Depression Inventory (BDI-II) Total Score
time frame: Baseline, Week 14
description: Beck Depression Inventory-II: BDI-II is a 21-item, participant-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to symptoms of depression were scored on a 4-point scale ranging from 0 to 3 and was summed to give a single score. A total score of 0-13 was considered minimal range, 14-19 was mild, 20-28 was moderate, and 29-63 was severe. Least squares (LS) mean was calculated using a ANCOVA approach' including administration groups as fixed effects, and baseline data as covariate.
measure: Percentage of Participants With Fall Events From Fall Questionnaire
time frame: Baseline through Week 14
description: Participants evaluated their experience with and details of falls which were recorded.
measure: Change From Baseline on the Western Ontario and McMaster Osteoarthritis Index (WOMAC) Questionnaire Total Score
time frame: Baseline, Week 14
description: The 24-question WOMAC Osteoarthritis Index assesses osteoarthritis symptoms using pain (5 questions), stiffness (2 questions) and physical function (17 questions) subscales. The WOMAC Osteoarthritis Index version 3.1 was administered according to the study schedule. The WOMAC total score was calculated for each participant at each time point for analysis as the mean total score, range 0 (none) -96 (extreme). Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach including administration groups, observation points, and interaction between the administration groups and observation points as fixed effects, and baseline data as covariates.
measure: Change From Baseline on the Patient Global Assessment Illness (PGAI) Score
time frame: Baseline, Week 14
measure: Change From Baseline on the 5 Dimension (EQ-5D) Version of the European Quality of Life Instrument
time frame: Baseline, Week 14
description: The EQ-5D is a generic, multidimensional, health-related, quality-of-life instrument and was completed on five dimensions (mobility, self care, usual activities, pain/discomfort and anxiety/depression) to measure health-related quality of life on a scale from 0-1, with the higher score indicating a better health state perceived by the participant. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood using a three level scale (no problem, some problems, and major problems). These combinations of attributes were converted into a weighted health-state Index Score according to the Japan population-based algorithm. Least squares (LS) mean was calculated using an ANCOVA approach including administration groups as fixed effects, and baseline data as covariate.
measure: Change in Baseline in Brief Pain Inventory Severity and Interference Scores (BPI-S, BPI-I) Change From Baseline in BPI Pain Severity Items and Interference Items Score
time frame: Baseline, Week 14
description: BPI-S and BPI-I are self-reported scales measuring severity of pain and interference on function. Severity scores: 0 (no pain) to 10 (severe pain) on each question assessing worst pain, least pain, and average pain in past 24 hours, and pain right now. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference = average of non-missing scores of individual interference items. Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach including administration groups, observation points, and interaction between the administration groups and observation points as fixed effects, and baseline data as covariates.
measure: Percentage of Participants With a 30% and 50% Reduction in Average Pain Score on Weekly Mean of the 24-Hour Average Pain Score on the 11-Point Numeric Rating Scale
time frame: Baseline,Week 14
description: 24-hour average pain severity scores were recorded daily on an 11-point Likert scale, an ordinal scale, with scores ranging from 0 (no pain) to 10 (worst possible pain). The 11-point Likert scale was also used for assessment of average pain within 24-hours.
measure: Change From Baseline on Weekly Mean of the 24-Hour Average Pain and Worst Pain Score
time frame: Baseline, Week 14
description: 24-hour average pain severity scores were recorded daily on an 11-point Likert scale, an ordinal scale, with scores ranging from 0 (no pain) to 10 (worst possible pain). The 11-point Likert scale was also used for assessment of average pain and worst pain within 24-hours. Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach including administration groups, observation points, and interaction between the administration groups and observation points as fixed effects, and baseline data as covariates.
measure: Percentage of Participants With Reduction of ≥30% and ≥50% in BPI Average Pain Score
time frame: Baseline, Week 14
description: Brief Pain Inventory Severity: Average Pain Score: A self-reported scale that measures the severity of pain based on the average pain experienced during the past 24-hours. The severity scores ranged from 0 (no pain) to 10 (pain as severe as you can imagine).
measure: Percentage of Participants With a Responder Rate Based on OMERACT-OARSI Criteria
time frame: Baseline, Week 14
description: A responder is required to meet at least one condition: reduction of ≥50% and ≥2 score in Weekly Mean of the 24-Hour Average Pain Score, reduction of ≥50% or ≥13.6 score in WOMAC (difficulty in dairy activity) and meet ≥2 out of following 3 conditions: reduction of ≥20% and ≥1 score in Weekly Mean of the 24-Hour Average Pain, reduction of ≥20% and ≥6.8 score in WOMAC (difficulty in dairy activity), PGAI score ≥2.
measure: Change From Baseline on the WOMAC Questionnaire Pain Subscale
time frame: Baseline, 14 Weeks
description: The WOMAC index (pain, stiffness, physical function subscales) was completed by the participant.The pain subscale had 5 questions on pain associated with every day tasks. Each question was answered using a 5-point Likert scale (0 to 4). The pain subscale has a range of scores of 0 (none) to 20 (extreme). Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach including administration groups, observation points, and interaction between the administration groups and observation points as fixed effects, baseline data as covariates.
measure: Change From Baseline on the WOMAC Questionnaire Stiffness Subscale
time frame: Baseline, 14 Weeks
description: The WOMAC index (pain, stiffness, physical function subscales) will be completed by the participant.The stiffness subscale had 2 questions on stiffness associated with time of day (morning versus later in the day). Each question was answered using a 5-point Likert scale (0 to 4). The stiffness subscale has a range of scores of 0 (none) to 8 (extreme). Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach including administration groups, observation points, and interaction between the administration groups and observation points as fixed effects, baseline data as covariates.
measure: Change From Baseline on the WOMAC Questionnaire Physical Function Subscale
time frame: Baseline, 14 Weeks
description: The WOMAC osteoarthritis scale consists of 24 items in 3 subscales: pain, stiffness, and physical function. The physical function subscale rates participant pain during stair use, rising from sitting, standing, bending, walking, getting in/out of a car, shopping, putting on/taking off socks, rising from bed, lying in bed, getting in/out of the bath, sitting, getting on/off the toilet, heavy household duties, and light household duties. Each question was answered using a 5-point Likert scale (0 to 4). Physical Function Subscale has a range of scores of 0 (none) to 68 (extreme). Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach including administration groups, observation points, and interaction between the administration groups and observation points as fixed effects, baseline data as covariates.
arm group label: Duloxetine
arm group type: Experimental
description: Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo administered orally once a day for 15 weeks.
intervention type: Drug
intervention name: Duloxetine
description: Administered orally
arm group label: Duloxetine
other name: LY248686
intervention type: Drug
intervention name: Placebo
description: Administered orally
arm group label: Placebo
criteria: 
gender: All
minimum age: 40 Years
maximum age: 79 Years
healthy volunteers: No
last name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: Study Director
affiliation: Eli Lilly and Company
facility: 
country: Japan
responsible party type: Sponsor
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee
mesh term: Duloxetine Hydrochloride
sharing ipd: Yes
ipd description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)
ipd time frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
ipd access criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
ipd url: https://vivli.org/
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 