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/NCT06017999</url>
    </required_header>
    <id_info>
      <org_study_id>PR-XG005-02-BUN-01</org_study_id>
      <nct_id>NCT06017999</nct_id>
    </id_info>
    <brief_title>XG005 for Pain Control in Subjects Undergoing Bunionectomy</brief_title>
    <official_title>A Randomized, Double-Blind, Placebo Controlled Trial to Evaluate the Safety and Efficacy of XG005 Tablets in Subjects Undergoing Bunionectomy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Xgene Pharmaceutical Group</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Xgene Pharmaceutical Group</source>
    <oversight_info>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study will evaluate the safety, efficacy, and PK of low dose (750 mg) and high-dose&#xD;
        (1250 mg) XG005 oral tablets compared with placebo in subjects undergoing bunionectomy.&#xD;
        Subjects will be confined in the clinic from check-in through 72 hours post-surgery to&#xD;
        monitor subject safety.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a multi-center, randomized, double-blind, parallel-group, placebo-controlled study.&#xD;
        Eligible subjects will be randomized in a 1:1:1 ratio to receive either 750 mg XG005, 1250 mg&#xD;
        XG005, or placebo, twice a day, post bunionectomy surgery in domiciled clinic. Subjects and&#xD;
        all study staff performing study assessments will be blinded to treatment allocation.&#xD;
        Subjects will be discharged at a reasonable hour of the day after the end of the 72-hour&#xD;
        treatment period.There will be a Follow-up Visit on Day 15.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 8, 2023</start_date>
    <completion_date type="Anticipated">August 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">May 31, 2024</primary_completion_date>
    <phase>Phase 2/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>Prevention</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Summed pain intensity from end of surgery to 48 hours post-surgery</measure>
      <time_frame>0 to 72 hours post-surgery</time_frame>
      <description>Pain assessments via a standard 11-point NPRS at the various time points post-end of surgery</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Total tramadol rescue medication consumption</measure>
      <time_frame>0 to 72 hours post-surgery</time_frame>
      <description>Tramadol 50 mg, PRN</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to first use of rescue medication from end of surgery</measure>
      <time_frame>0 to 72 hours post-surgery</time_frame>
      <description>Acetaminophen 1g, PRN</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient Global Assessment (PGA) at 48 hours</measure>
      <time_frame>0 to 72 hours post-surgery</time_frame>
      <description>PGA of pain control using a 5 point scale at the following time points post-surgery</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cumulative Nausea (NNRS) assessment scores through 24 hours</measure>
      <time_frame>0 to 72 hours post-surgery</time_frame>
      <description>NNRS assessment scores at various time points</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>TEAEs</measure>
      <time_frame>Day 1 to Day 30</time_frame>
      <description>First dose of study drug to 30 days after the last dose of study drug</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Continuous Pulse Oximetry</measure>
      <time_frame>0 to 72 hours post-surgery</time_frame>
      <description>oxygen saturation (Sp02) will be recorded every 12 hours post-end of surgery.</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">450</enrollment>
    <condition>Acute Pain</condition>
    <arm_group>
      <arm_group_label>high dose</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>XG005 1250 mg Q12 hours</description>
    </arm_group>
    <arm_group>
      <arm_group_label>low dose</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>XG005 750 mg Q12 hours</description>
    </arm_group>
    <arm_group>
      <arm_group_label>placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>placebo Q12 hours</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>XG005 tablet</intervention_name>
      <description>Subjects will receive XG005 prior to surgery and every 12 hours for 72 hours.</description>
      <arm_group_label>high dose</arm_group_label>
      <arm_group_label>low dose</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo tablet</intervention_name>
      <description>Subjects will receive placebo prior to surgery and every 12 hours for 72 hours.</description>
      <arm_group_label>low dose</arm_group_label>
      <arm_group_label>placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Main inclusion criteria:&#xD;
  &#xD;
            -  Scheduled to undergo unilateral first metatarsal bunionectomy&#xD;
  &#xD;
            -  Have negative urine drug screen&#xD;
  &#xD;
            -  Non-pregnant, non-lactating&#xD;
  &#xD;
          Main exclusion criteria:&#xD;
  &#xD;
            -  Medical condition or history that in the investigator's opinion could adversely impact&#xD;
               the subject's participation or safety&#xD;
  &#xD;
            -  Use of disallowed medications (e.g. pain medication, CNS active drugs such as&#xD;
               benzodiazepines, tricyclic antidepressants, Serotonin, and norepinephrine reuptake&#xD;
               inhibitors (SNRIs), selective serotonin reuptake inhibitors (SSRIs), or any other&#xD;
               serotonergic medications, parenteral or oral corticosteroids)&#xD;
  &#xD;
            -  Antihypertensive agent or diabetic regimen at a dose that has not been stable for at&#xD;
               least 30 days&#xD;
  &#xD;
            -  Digoxin, warfarin lithium, theophylline preparations, aminoglycosides, and all&#xD;
               antiarrhythmics&#xD;
  &#xD;
            -  Monoamine oxidase inhibitors (MAOIs)&#xD;
  &#xD;
            -  Positive HbsAg and/or anti-HBc but negative anti-HBs&#xD;
  &#xD;
            -  HIV infection&#xD;
  &#xD;
            -  History of illicit drug use&#xD;
  &#xD;
            -  History of opioid dependence&#xD;
  &#xD;
            -  History of NSAID-induced bronchospasm or presence of nasal polyps, history of asthma&#xD;
               or chronic rhinitis&#xD;
  &#xD;
            -  Significant history of allergic reactions or known intolerance to naproxen, pregabalin&#xD;
               or any gabapentinoid, or to any rescue medication used in the study, or any medication&#xD;
               used in the surgical and anesthetic protocol.&#xD;
  &#xD;
            -  Presence of severe depression as indicated by Patient Health Questionnaire (PHQ 9)&#xD;
               total score of ≥20 or item 9 score &gt;0&#xD;
  &#xD;
            -  Presence of severe anxiety as indicated by General Anxiety Disorder (GAD-7) score of&#xD;
               ≥15&#xD;
  &#xD;
            -  Presence of history of suicidal behavior or ideation as indicated by the C-SSRS&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Joey Chang</last_name>
      <phone>312-468-5090</phone>
      <email>joey.chang@xgenepharm.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Midwest Clinical Research Center</name>
        <address>
          <city>Dayton</city>
          <state>Ohio</state>
          <zip>45417</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>First Surgical Hospital</name>
        <address>
          <city>Bellaire</city>
          <state>Texas</state>
          <zip>77401</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Legent Orthopedic Hospital</name>
        <address>
          <city>Carrollton</city>
          <state>Texas</state>
          <zip>75006</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Memorial Hermann Village</name>
        <address>
          <city>Houston</city>
          <state>Texas</state>
          <zip>77043</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Endeavor Clinical Trials</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>August 2023</verification_date>
    <study_first_submitted>August 18, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 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>Acute Pain</mesh_term>
    </condition_browse>
    <!-- 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/NCT06017999
  org study id: PR-XG005-02-BUN-01
  nct id: NCT06017999
  lead sponsor: 
  is fda regulated drug: Yes
  is fda regulated device: No
  This study will evaluate the safety, efficacy, and PK of low dose (750 mg) and high-dose
        (1250 mg) XG005 oral tablets compared with placebo in subjects undergoing bunionectomy.
        Subjects will be confined in the clinic from check-in through 72 hours post-surgery to
        monitor subject safety.
  This is a multi-center, randomized, double-blind, parallel-group, placebo-controlled study.
        Eligible subjects will be randomized in a 1:1:1 ratio to receive either 750 mg XG005, 1250 mg
        XG005, or placebo, twice a day, post bunionectomy surgery in domiciled clinic. Subjects and
        all study staff performing study assessments will be blinded to treatment allocation.
        Subjects will be discharged at a reasonable hour of the day after the end of the 72-hour
        treatment period.There will be a Follow-up Visit on Day 15.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Summed pain intensity from end of surgery to 48 hours post-surgery
  time frame: 0 to 72 hours post-surgery
  description: Pain assessments via a standard 11-point NPRS at the various time points post-end of surgery
  measure: Total tramadol rescue medication consumption
  time frame: 0 to 72 hours post-surgery
  description: Tramadol 50 mg, PRN
  measure: Time to first use of rescue medication from end of surgery
  time frame: 0 to 72 hours post-surgery
  description: Acetaminophen 1g, PRN
  measure: Patient Global Assessment (PGA) at 48 hours
  time frame: 0 to 72 hours post-surgery
  description: PGA of pain control using a 5 point scale at the following time points post-surgery
  measure: Cumulative Nausea (NNRS) assessment scores through 24 hours
  time frame: 0 to 72 hours post-surgery
  description: NNRS assessment scores at various time points
  measure: TEAEs
  time frame: Day 1 to Day 30
  description: First dose of study drug to 30 days after the last dose of study drug
  measure: Continuous Pulse Oximetry
  time frame: 0 to 72 hours post-surgery
  description: oxygen saturation (Sp02) will be recorded every 12 hours post-end of surgery.
  arm group label: high dose
  arm group type: Experimental
  description: XG005 1250 mg Q12 hours
  arm group label: low dose
  arm group type: Experimental
  description: XG005 750 mg Q12 hours
  arm group label: placebo
  arm group type: Placebo Comparator
  description: placebo Q12 hours
  intervention type: Drug
  intervention name: XG005 tablet
  description: Subjects will receive XG005 prior to surgery and every 12 hours for 72 hours.
  arm group label: high dose
  arm group label: low dose
  intervention type: Drug
  intervention name: Placebo tablet
  description: Subjects will receive placebo prior to surgery and every 12 hours for 72 hours.
  arm group label: low dose
  arm group label: placebo
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Joey Chang
  phone: 312-468-5090
  email: joey.chang@xgenepharm.com
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Recruiting
  country: United States
  responsible party type: Sponsor
  mesh term: Acute Pain