xml: <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/NCT05986292</url>
    </required_header>
    <id_info>
      <org_study_id>17511</org_study_id>
      <secondary_id>H0P-MC-CPMP</secondary_id>
      <nct_id>NCT05986292</nct_id>
    </id_info>
    <brief_title>A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain</brief_title>
    <acronym>CPMP</acronym>
    <official_title>A Master Protocol for Randomized, Placebo-Controlled, Phase 2 Clinical Trials of Multiple Interventions for the Treatment of Chronic Pain</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Eli Lilly and Company</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Eli Lilly and Company</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of the chronic pain master protocol is to compare independent pain interventions&#xD;
        and establish an overarching structure for the disease-state addenda (DSA) and&#xD;
        intervention-specific appendices (ISAs). The ISAs may start independently of other ISAs as&#xD;
        interventions become available for clinical testing.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The chronic pain master protocol (CPMP) establishes entry criteria and includes DSA for&#xD;
        osteoarthritis of the knee, chronic low back pain, and diabetic peripheral neuropathic pain.&#xD;
        The DSA have specific study elements to appropriately define the target population and unique&#xD;
        scales for assessment. Also, the master protocol governs ISAs that may start independently of&#xD;
        other ISAs as interventions become available for clinical testing.&#xD;
  &#xD;
        Note: Results for all outcomes are posted in the intervention records. No need for&#xD;
        duplication.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 30, 2020</start_date>
    <completion_date type="Anticipated">April 25, 2027</completion_date>
    <primary_completion_date type="Anticipated">April 25, 2027</primary_completion_date>
    <phase>Phase 2</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>Screening</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Number of Participants Who Were Allocated to Each ISA</measure>
      <time_frame>Baseline, Up to Week 8</time_frame>
    </primary_outcome>
    <number_of_arms>12</number_of_arms>
    <enrollment type="Anticipated">10000</enrollment>
    <condition>Osteoarthritis, Knee</condition>
    <condition>Diabetic Neuropathic Pain</condition>
    <condition>Chronic Low-back Pain</condition>
    <arm_group>
      <arm_group_label>LY3016859 Osteoarthritis ISA</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants are randomized to receive either active LY3016859 or matching placebo</description>
    </arm_group>
    <arm_group>
      <arm_group_label>LY3016859 Diabetic Neuropathic Pain ISA</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants are randomized to receive either active LY3016859 or matching placebo</description>
    </arm_group>
    <arm_group>
      <arm_group_label>LY3016859 Chronic Back Pain ISA</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants are randomized to receive either active LY3016859 or matching placebo</description>
    </arm_group>
    <arm_group>
      <arm_group_label>LY3556050 Osteoarthritis ISA</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants are randomized to receive either active LY3556050 or matching placebo</description>
    </arm_group>
    <arm_group>
      <arm_group_label>LY3556050 Diabetic Neuropathic Pain ISA</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants are randomized to receive either active LY3556050 or matching placebo</description>
    </arm_group>
    <arm_group>
      <arm_group_label>LY3556050 Chronic Back Pain ISA</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants are randomized to receive either active LY3556050 or matching placebo</description>
    </arm_group>
    <arm_group>
      <arm_group_label>LY3526318 Osteoarthritis ISA</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants are randomized to receive either active LY3526318 or matching placebo</description>
    </arm_group>
    <arm_group>
      <arm_group_label>LY3526318 Diabetic Neuropathic Pain ISA</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants are randomized to receive either active LY3526318 or matching placebo</description>
    </arm_group>
    <arm_group>
      <arm_group_label>LY3526318 Chronic Back Pain ISA</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants are randomized to receive either active LY3526318 or matching placebo</description>
    </arm_group>
    <arm_group>
      <arm_group_label>LY3857210 Osteoarthritis ISA</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants are randomized to receive either active LY3857210 or matching placebo</description>
    </arm_group>
    <arm_group>
      <arm_group_label>LY3857210 Diabetic Neuropathic Pain ISA</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants are randomized to receive either active LY3857210 or matching placebo</description>
    </arm_group>
    <arm_group>
      <arm_group_label>LY3857210 Chronic Back Pain ISA</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants are randomized to receive either active LY3857210 or matching placebo</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>LY3016859 ISA</intervention_name>
      <description>Administered intravenously (IV)</description>
      <arm_group_label>LY3016859 Chronic Back Pain ISA</arm_group_label>
      <arm_group_label>LY3016859 Diabetic Neuropathic Pain ISA</arm_group_label>
      <arm_group_label>LY3016859 Osteoarthritis ISA</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>LY3556050 ISA</intervention_name>
      <description>Administered orally</description>
      <arm_group_label>LY3556050 Chronic Back Pain ISA</arm_group_label>
      <arm_group_label>LY3556050 Diabetic Neuropathic Pain ISA</arm_group_label>
      <arm_group_label>LY3556050 Osteoarthritis ISA</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>LY3526318 ISA</intervention_name>
      <description>Administered orally</description>
      <arm_group_label>LY3526318 Chronic Back Pain ISA</arm_group_label>
      <arm_group_label>LY3526318 Diabetic Neuropathic Pain ISA</arm_group_label>
      <arm_group_label>LY3526318 Osteoarthritis ISA</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>LY3857210 ISA</intervention_name>
      <description>Administered orally</description>
      <arm_group_label>LY3857210 Chronic Back Pain ISA</arm_group_label>
      <arm_group_label>LY3857210 Diabetic Neuropathic Pain ISA</arm_group_label>
      <arm_group_label>LY3857210 Osteoarthritis ISA</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo Oral</intervention_name>
      <description>Placebo administered orally</description>
      <arm_group_label>LY3526318 Chronic Back Pain ISA</arm_group_label>
      <arm_group_label>LY3526318 Diabetic Neuropathic Pain ISA</arm_group_label>
      <arm_group_label>LY3526318 Osteoarthritis ISA</arm_group_label>
      <arm_group_label>LY3556050 Chronic Back Pain ISA</arm_group_label>
      <arm_group_label>LY3556050 Diabetic Neuropathic Pain ISA</arm_group_label>
      <arm_group_label>LY3556050 Osteoarthritis ISA</arm_group_label>
      <arm_group_label>LY3857210 Chronic Back Pain ISA</arm_group_label>
      <arm_group_label>LY3857210 Diabetic Neuropathic Pain ISA</arm_group_label>
      <arm_group_label>LY3857210 Osteoarthritis ISA</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Placebo administered IV</description>
      <arm_group_label>LY3016859 Chronic Back Pain ISA</arm_group_label>
      <arm_group_label>LY3016859 Diabetic Neuropathic Pain ISA</arm_group_label>
      <arm_group_label>LY3016859 Osteoarthritis ISA</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  have a visual analog scale (VAS) pain value &gt;40 and &lt;95 at screening and&#xD;
               prerandomization screening.&#xD;
  &#xD;
            -  have a history of daily pain for at least 12 weeks based on participant report or&#xD;
               medical history&#xD;
  &#xD;
            -  have a value of ≤30 on the pain catastrophizing scale&#xD;
  &#xD;
            -  have a body mass index &lt;40 kilogram/square meter (kg/m²) (inclusive)&#xD;
  &#xD;
            -  are willing to maintain a consistent regimen of any ongoing nonpharmacologic&#xD;
               pain-relieving therapies (for example, physical therapy) and will not start any new&#xD;
               nonpharmacologic pain-relieving therapies during study participation.&#xD;
  &#xD;
            -  are willing to discontinue all medications taken for chronic pain conditions, except&#xD;
               rescue medication for the duration of the study&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  have second- or third-degree atrioventricular (AV) heart block or AV dissociation or&#xD;
               history of ventricular tachycardia&#xD;
  &#xD;
            -  have had a procedure within the past 6 months intended to produce permanent sensory&#xD;
               loss in the target area of interest (for example, ablation techniques)&#xD;
  &#xD;
            -  have surgery planned during the study for any reason, related or not to the disease&#xD;
               state under evaluation.&#xD;
  &#xD;
            -  have, in the judgment of the investigator, an acute, serious, or unstable medical&#xD;
               condition or a history or presence of any other medical illness that would preclude&#xD;
               study participation.&#xD;
  &#xD;
            -  have had cancer within 2 years of baseline, except for cutaneous basal cell or&#xD;
               squamous cell carcinoma resolved by excision.&#xD;
  &#xD;
            -  have fibromyalgia&#xD;
  &#xD;
            -  have substance use disorder as defined by the Diagnostic and Statistical Manual of&#xD;
               Mental Disorders (5th edition; DSM-5; American Psychiatric Association)&#xD;
  &#xD;
            -  have any clinically important abnormality at screening, as determined by investigator,&#xD;
               in physical or neurological examination, vital signs, electrocardiogram (ECG), or&#xD;
               clinical laboratory test results that could be detrimental to the participant or could&#xD;
               compromise the study.&#xD;
  &#xD;
            -  have a positive human immunodeficiency virus (HIV) test result at screening&#xD;
  &#xD;
            -  have a history of alcohol, illicit drug, analgesic or narcotic use disorder within 2&#xD;
               years prior to screening.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</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>
    <overall_contact>
      <last_name>There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or</last_name>
      <phone>1-317-615-4559</phone>
      <email>ClinicalTrials.gov@lilly.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>CMR of Greater New Haven, LLC</name>
        <address>
          <city>Hamden</city>
          <state>Connecticut</state>
          <zip>06517</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <investigator>
        <last_name>Joseph Soufer</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Encore Research Group- Jacksonville Center for Clinical Research</name>
        <address>
          <city>Jacksonville</city>
          <state>Florida</state>
          <zip>32216</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <investigator>
        <last_name>Carolyn M Tran</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Suncoast Research Group</name>
        <address>
          <city>Miami</city>
          <state>Florida</state>
          <zip>33135</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <investigator>
        <last_name>Mark Eliot Kutner</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>University of Miami Don Suffer Clinical Research Building</name>
        <address>
          <city>Miami</city>
          <state>Florida</state>
          <zip>33136</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <investigator>
        <last_name>Danielle Horn</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>New Horizon Research Center</name>
        <address>
          <city>Miami</city>
          <state>Florida</state>
          <zip>33165</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <investigator>
        <last_name>Lazaro D. Nunez</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Renstar Medical Research</name>
        <address>
          <city>Ocala</city>
          <state>Florida</state>
          <zip>34470</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <investigator>
        <last_name>David Lucius Oliver</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Synexus Clinical Research US, Inc.</name>
        <address>
          <city>Orlando</city>
          <state>Florida</state>
          <zip>32806</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <investigator>
        <last_name>ROBERT M MEYER</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Synexus Clinical Research - St. Petersburg</name>
        <address>
          <city>Pinellas Park</city>
          <state>Florida</state>
          <zip>33781</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <investigator>
        <last_name>Linda Murray</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Martin E. Hale M.D., P.A.</name>
        <address>
          <city>Plantation</city>
          <state>Florida</state>
          <zip>33317</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Completed</status>
    </location>
    <location>
      <facility>
        <name>Synexus Clinical Research US, Inc.</name>
        <address>
          <city>The Villages</city>
          <state>Florida</state>
          <zip>32162</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Completed</status>
    </location>
    <location>
      <facility>
        <name>North Georgia Clinical Research</name>
        <address>
          <city>Woodstock</city>
          <state>Georgia</state>
          <zip>30189</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <investigator>
        <last_name>Bram Wieskopf</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Rocky Mountain Clinical Research</name>
        <address>
          <city>Idaho Falls</city>
          <state>Idaho</state>
          <zip>83404</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <investigator>
        <last_name>Kevin T Prier</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Synexus Clinical Research</name>
        <address>
          <city>Chicago</city>
          <state>Illinois</state>
          <zip>60602</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Completed</status>
    </location>
    <location>
      <facility>
        <name>Physical Medicine and Rehabilitation</name>
        <address>
          <city>Chicago</city>
          <state>Illinois</state>
          <zip>60611</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <investigator>
        <last_name>Thomas Schnitzer</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Diabetes Research</name>
        <address>
          <city>Skokie</city>
          <state>Illinois</state>
          <zip>60077</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <investigator>
        <last_name>Liana Katz Billings</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Cotton O'Neil Clinical Research Center - Central Office</name>
        <address>
          <city>Topeka</city>
          <state>Kansas</state>
          <zip>66606</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Completed</status>
    </location>
    <location>
      <facility>
        <name>Boston Clinical Trials</name>
        <address>
          <city>Boston</city>
          <state>Massachusetts</state>
          <zip>02131</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <investigator>
        <last_name>Antonio Mendes</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>ActivMed Practices and Research</name>
        <address>
          <city>Methuen</city>
          <state>Massachusetts</state>
          <zip>01844</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <investigator>
        <last_name>Michael J. McCartney</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>MedVadis Research Corporation</name>
        <address>
          <city>Waltham</city>
          <state>Massachusetts</state>
          <zip>02451</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <investigator>
        <last_name>David DiBenedetto</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Great Lakes Research Group, Inc.</name>
        <address>
          <city>Bay City</city>
          <state>Michigan</state>
          <zip>48706</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <investigator>
        <last_name>Jeffrey A. Potts</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Research</name>
        <address>
          <city>Saint Peters</city>
          <state>Missouri</state>
          <zip>63303</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <investigator>
        <last_name>Timothy R Smith</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Clinvest Research LLC</name>
        <address>
          <city>Springfield</city>
          <state>Missouri</state>
          <zip>65807</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <investigator>
        <last_name>David Gregory True</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Synexus Clinical Research US, Inc.</name>
        <address>
          <city>Omaha</city>
          <state>Nebraska</state>
          <zip>68144</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Completed</status>
    </location>
    <location>
      <facility>
        <name>PharmQuest Life Sciences, LLC</name>
        <address>
          <city>Greensboro</city>
          <state>North Carolina</state>
          <zip>27408</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Completed</status>
    </location>
    <location>
      <facility>
        <name>Lillestol Research</name>
        <address>
          <city>Fargo</city>
          <state>North Dakota</state>
          <zip>58104</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <investigator>
        <last_name>Michael J Lillestol</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Synexus - Cincinnati</name>
        <address>
          <city>Cincinnati</city>
          <state>Ohio</state>
          <zip>45236</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Completed</status>
    </location>
    <location>
      <facility>
        <name>Rapid Medical Research</name>
        <address>
          <city>Cleveland</city>
          <state>Ohio</state>
          <zip>44122</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <investigator>
        <last_name>Joan Rothenberg</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Aventiv Research Inc</name>
        <address>
          <city>Columbus</city>
          <state>Ohio</state>
          <zip>43213</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Completed</status>
    </location>
    <location>
      <facility>
        <name>META Medical Research Institute</name>
        <address>
          <city>Dayton</city>
          <state>Ohio</state>
          <zip>45432</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <investigator>
        <last_name>Priyesh Mehta</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Clinical Research Center of Reading,LLC</name>
        <address>
          <city>Wyomissing</city>
          <state>Pennsylvania</state>
          <zip>19610</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Completed</status>
    </location>
    <location>
      <facility>
        <name>Coastal Carolina Research Center</name>
        <address>
          <city>North Charleston</city>
          <state>South Carolina</state>
          <zip>29405</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Completed</status>
    </location>
    <location>
      <facility>
        <name>FutureSearch Trials of Neurology</name>
        <address>
          <city>Austin</city>
          <state>Texas</state>
          <zip>78731</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <investigator>
        <last_name>John Douglas Hudson</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Synexus</name>
        <address>
          <city>Dallas</city>
          <state>Texas</state>
          <zip>75234</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Completed</status>
    </location>
    <location>
      <facility>
        <name>Cedar Health Research</name>
        <address>
          <city>Dallas</city>
          <state>Texas</state>
          <zip>75251</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Completed</status>
    </location>
    <location>
      <facility>
        <name>Synexus Clinical Research US, Inc.</name>
        <address>
          <city>San Antonio</city>
          <state>Texas</state>
          <zip>78229</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <investigator>
        <last_name>Hilario Alvarado</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>SYNEXUS</name>
        <address>
          <city>Murray</city>
          <state>Utah</state>
          <zip>84123</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Completed</status>
    </location>
    <location>
      <facility>
        <name>Northwest Clinical Research Center</name>
        <address>
          <city>Bellevue</city>
          <state>Washington</state>
          <zip>98007</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <investigator>
        <last_name>Arifulla Khan, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Rainier Clinical Research Center</name>
        <address>
          <city>Renton</city>
          <state>Washington</state>
          <zip>98057</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <investigator>
        <last_name>Frances Eileen Broyles</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Ponce Medical School Foundation Inc.</name>
        <address>
          <city>Ponce</city>
          <zip>00716</zip>
          <country>Puerto Rico</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <investigator>
        <last_name>Elizabeth A. Barranco-Santana</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Puerto Rico</country>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 1, 2023</study_first_submitted>
    <study_first_submitted_qc>August 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</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, Knee</mesh_term>
      <mesh_term>Neuralgia</mesh_term>
      <mesh_term>Low Back Pain</mesh_term>
      <mesh_term>Chronic Pain</mesh_term>
    </condition_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 European Union (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>http://vivli.org/</ipd_url>
    </patient_data>
    <provided_document_section>
      <provided_document>
        <document_type>Study Protocol</document_type>
        <document_has_protocol>Yes</document_has_protocol>
        <document_has_icf>No</document_has_icf>
        <document_has_sap>No</document_has_sap>
        <document_date>December 11, 2020</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/92/NCT05986292/Prot_005.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05986292
  org study id: 17511
  secondary id: H0P-MC-CPMP
  nct id: NCT05986292
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  The purpose of the chronic pain master protocol is to compare independent pain interventions
        and establish an overarching structure for the disease-state addenda (DSA) and
        intervention-specific appendices (ISAs). The ISAs may start independently of other ISAs as
        interventions become available for clinical testing.
  The chronic pain master protocol (CPMP) establishes entry criteria and includes DSA for
        osteoarthritis of the knee, chronic low back pain, and diabetic peripheral neuropathic pain.
        The DSA have specific study elements to appropriately define the target population and unique
        scales for assessment. Also, the master protocol governs ISAs that may start independently of
        other ISAs as interventions become available for clinical testing.
  
        Note: Results for all outcomes are posted in the intervention records. No need for
        duplication.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Screening
  masking: Double (Participant, Investigator)
  measure: Number of Participants Who Were Allocated to Each ISA
  time frame: Baseline, Up to Week 8
  arm group label: LY3016859 Osteoarthritis ISA
  arm group type: Experimental
  description: Participants are randomized to receive either active LY3016859 or matching placebo
  arm group label: LY3016859 Diabetic Neuropathic Pain ISA
  arm group type: Experimental
  description: Participants are randomized to receive either active LY3016859 or matching placebo
  arm group label: LY3016859 Chronic Back Pain ISA
  arm group type: Experimental
  description: Participants are randomized to receive either active LY3016859 or matching placebo
  arm group label: LY3556050 Osteoarthritis ISA
  arm group type: Experimental
  description: Participants are randomized to receive either active LY3556050 or matching placebo
  arm group label: LY3556050 Diabetic Neuropathic Pain ISA
  arm group type: Experimental
  description: Participants are randomized to receive either active LY3556050 or matching placebo
  arm group label: LY3556050 Chronic Back Pain ISA
  arm group type: Experimental
  description: Participants are randomized to receive either active LY3556050 or matching placebo
  arm group label: LY3526318 Osteoarthritis ISA
  arm group type: Experimental
  description: Participants are randomized to receive either active LY3526318 or matching placebo
  arm group label: LY3526318 Diabetic Neuropathic Pain ISA
  arm group type: Experimental
  description: Participants are randomized to receive either active LY3526318 or matching placebo
  arm group label: LY3526318 Chronic Back Pain ISA
  arm group type: Experimental
  description: Participants are randomized to receive either active LY3526318 or matching placebo
  arm group label: LY3857210 Osteoarthritis ISA
  arm group type: Experimental
  description: Participants are randomized to receive either active LY3857210 or matching placebo
  arm group label: LY3857210 Diabetic Neuropathic Pain ISA
  arm group type: Experimental
  description: Participants are randomized to receive either active LY3857210 or matching placebo
  arm group label: LY3857210 Chronic Back Pain ISA
  arm group type: Experimental
  description: Participants are randomized to receive either active LY3857210 or matching placebo
  intervention type: Drug
  intervention name: LY3016859 ISA
  description: Administered intravenously (IV)
  arm group label: LY3016859 Chronic Back Pain ISA
  arm group label: LY3016859 Diabetic Neuropathic Pain ISA
  arm group label: LY3016859 Osteoarthritis ISA
  intervention type: Drug
  intervention name: LY3556050 ISA
  description: Administered orally
  arm group label: LY3556050 Chronic Back Pain ISA
  arm group label: LY3556050 Diabetic Neuropathic Pain ISA
  arm group label: LY3556050 Osteoarthritis ISA
  intervention type: Drug
  intervention name: LY3526318 ISA
  description: Administered orally
  arm group label: LY3526318 Chronic Back Pain ISA
  arm group label: LY3526318 Diabetic Neuropathic Pain ISA
  arm group label: LY3526318 Osteoarthritis ISA
  intervention type: Drug
  intervention name: LY3857210 ISA
  description: Administered orally
  arm group label: LY3857210 Chronic Back Pain ISA
  arm group label: LY3857210 Diabetic Neuropathic Pain ISA
  arm group label: LY3857210 Osteoarthritis ISA
  intervention type: Drug
  intervention name: Placebo Oral
  description: Placebo administered orally
  arm group label: LY3526318 Chronic Back Pain ISA
  arm group label: LY3526318 Diabetic Neuropathic Pain ISA
  arm group label: LY3526318 Osteoarthritis ISA
  arm group label: LY3556050 Chronic Back Pain ISA
  arm group label: LY3556050 Diabetic Neuropathic Pain ISA
  arm group label: LY3556050 Osteoarthritis ISA
  arm group label: LY3857210 Chronic Back Pain ISA
  arm group label: LY3857210 Diabetic Neuropathic Pain ISA
  arm group label: LY3857210 Osteoarthritis ISA
  intervention type: Drug
  intervention name: Placebo
  description: Placebo administered IV
  arm group label: LY3016859 Chronic Back Pain ISA
  arm group label: LY3016859 Diabetic Neuropathic Pain ISA
  arm group label: LY3016859 Osteoarthritis ISA
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  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
  last name: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
  phone: 1-317-615-4559
  email: ClinicalTrials.gov@lilly.com
  facility: 
  status: Recruiting
  investigator: 
  facility: 
  status: Recruiting
  investigator: 
  facility: 
  status: Recruiting
  investigator: 
  facility: 
  status: Recruiting
  investigator: 
  facility: 
  status: Recruiting
  investigator: 
  facility: 
  status: Recruiting
  investigator: 
  facility: 
  status: Recruiting
  investigator: 
  facility: 
  status: Recruiting
  investigator: 
  facility: 
  status: Completed
  facility: 
  status: Completed
  facility: 
  status: Recruiting
  investigator: 
  facility: 
  status: Recruiting
  investigator: 
  facility: 
  status: Completed
  facility: 
  status: Recruiting
  investigator: 
  facility: 
  status: Recruiting
  investigator: 
  facility: 
  status: Completed
  facility: 
  status: Recruiting
  investigator: 
  facility: 
  status: Recruiting
  investigator: 
  facility: 
  status: Recruiting
  investigator: 
  facility: 
  status: Recruiting
  investigator: 
  facility: 
  status: Recruiting
  investigator: 
  facility: 
  status: Recruiting
  investigator: 
  facility: 
  status: Completed
  facility: 
  status: Completed
  facility: 
  status: Recruiting
  investigator: 
  facility: 
  status: Completed
  facility: 
  status: Recruiting
  investigator: 
  facility: 
  status: Completed
  facility: 
  status: Recruiting
  investigator: 
  facility: 
  status: Completed
  facility: 
  status: Completed
  facility: 
  status: Recruiting
  investigator: 
  facility: 
  status: Completed
  facility: 
  status: Completed
  facility: 
  status: Recruiting
  investigator: 
  facility: 
  status: Completed
  facility: 
  status: Recruiting
  investigator: 
  facility: 
  status: Recruiting
  investigator: 
  facility: 
  status: Recruiting
  investigator: 
  country: Puerto Rico
  country: United States
  responsible party type: Sponsor
  mesh term: Osteoarthritis, Knee
  mesh term: Neuralgia
  mesh term: Low Back Pain
  mesh term: Chronic Pain
  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 European Union (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: http://vivli.org/
  provided document: 