<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/NCT04430088</url>
  </required_header>
  <id_info>
    <org_study_id>VVZ149-POP-P3-US005</org_study_id>
    <nct_id>NCT04430088</nct_id>
  </id_info>
  <brief_title>Phase 3 Efficacy and Safety Study of VVZ-149 Injections for Postoperative Pain Following Bunionectomy</brief_title>
  <official_title>A Phase 3, Multicenter, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of VVZ-149 Injections for the Treatment of Postoperative Pain Following Bunionectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vivozon, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Vivozon, Inc.</source>
  <oversight_info>
    <has_dmc>No</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 this phase 3 study is to evaluate the efficacy and safety of an analgesic drug&#xD;
      candidate, VVZ-149 Injections for treating post-operative pain following bunionectomy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 26, 2020</start_date>
  <completion_date type="Anticipated">January 2021</completion_date>
  <primary_completion_date type="Anticipated">December 2020</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time-weighted Sum of Pain Intensity Difference (SPID) from baseline over 12 hours after the start of study drug infusion (i.e., post-dose)</measure>
    <time_frame>0-12 hours post-dose</time_frame>
    <description>Using Numeric Pain Rating Scale (NRS, 0-10)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to onset of perceptible pain relief using the double stopwatch method</measure>
    <time_frame>0-12 hours post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total number of rescue medication request between 0-12 hours post-dose</measure>
    <time_frame>0-12 hours post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients with &gt;40% improvement in pain from baseline to 6 hours post-dose</measure>
    <time_frame>0-6 hours post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients who take prescription opioid after discharge</measure>
    <time_frame>2 weeks after discharge</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Pain, Postoperative</condition>
  <arm_group>
    <arm_group_label>VVZ-149 Injections</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>VVZ-149 Injections</intervention_name>
    <description>IV infusion of 1000 mg of VVZ-149</description>
    <arm_group_label>VVZ-149 Injections</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>IV infusion of 0 mg of VVZ-149</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men and women must be at least 18 years of age. Female subjects must meet additional&#xD;
             criteria in relation to childbearing potential.&#xD;
&#xD;
          -  Subjects must be undergoing a planned first metatarsal bunionectomy with osteotomy and&#xD;
             internal fixation (Austin bunionectomy) without collateral procedures.&#xD;
&#xD;
          -  Subjects must have the ability to provide written informed consent.&#xD;
&#xD;
          -  Subjects must have the ability to understand study procedures and communicate clearly&#xD;
             with the Investigator and staff.&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          -  Subjects undergoing emergency or unplanned surgery.&#xD;
&#xD;
          -  Subjects who had any previous bunionectomy procedure on either foot.&#xD;
&#xD;
          -  Subjects with pre-existing conditions (other than bunion) causing preoperative pain at&#xD;
             the site of surgery.&#xD;
&#xD;
          -  Female subjects who are pregnant or breastfeeding.&#xD;
&#xD;
          -  Diagnosis of chronic pain and ongoing or frequent use of pain medications.&#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_contact>
    <last_name>Clinical Trial Operations</last_name>
    <phone>+1-609-269-9140</phone>
    <email>clinicaltrials@vivozon.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Arizona Clinical Trial Site</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85053</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>California Clinical Trial Site</name>
      <address>
        <city>Anaheim</city>
        <state>California</state>
        <zip>92801</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Texas Clinical Trial Site</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 9, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 12, 2020</study_first_posted>
  <last_update_submitted>July 22, 2020</last_update_submitted>
  <last_update_submitted_qc>July 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 23, 2020</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>Pain, Postoperative</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT04430088
org study id: VVZ149-POP-P3-US005
nct id: NCT04430088
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this phase 3 study is to evaluate the efficacy and safety of an analgesic drug
      candidate, VVZ-149 Injections for treating post-operative pain following bunionectomy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Time-weighted Sum of Pain Intensity Difference (SPID) from baseline over 12 hours after the start of study drug infusion (i.e., post-dose)
time frame: 0-12 hours post-dose
description: Using Numeric Pain Rating Scale (NRS, 0-10)
measure: Time to onset of perceptible pain relief using the double stopwatch method
time frame: 0-12 hours post-dose
measure: Total number of rescue medication request between 0-12 hours post-dose
time frame: 0-12 hours post-dose
measure: Proportion of patients with >40% improvement in pain from baseline to 6 hours post-dose
time frame: 0-6 hours post-dose
measure: Proportion of patients who take prescription opioid after discharge
time frame: 2 weeks after discharge
arm group label: VVZ-149 Injections
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: VVZ-149 Injections
description: IV infusion of 1000 mg of VVZ-149
arm group label: VVZ-149 Injections
intervention type: Drug
intervention name: Placebo
description: IV infusion of 0 mg of VVZ-149
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Clinical Trial Operations
phone: +1-609-269-9140
email: clinicaltrials@vivozon.com
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
country: United States
responsible party type: Sponsor
mesh term: Pain, Postoperative