<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/NCT02197156</url>
  </required_header>
  <id_info>
    <org_study_id>ELN154088-201</org_study_id>
    <nct_id>NCT02197156</nct_id>
  </id_info>
  <brief_title>A Multicenter Active Comparator Study of HC-ER in Adults Following Bunionectomy Surgery</brief_title>
  <official_title>A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Active Comparator Study of Hydrocodone Bitartrate Extended Release (HC-ER) in Adults Following Bunionectomy Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zogenix, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>UCB Pharma</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to establish a dose-response relationship among several capsule&#xD;
      strengths of Hydrocodone Bitartrate Extended Release (HC-ER) and to compare the efficacy to&#xD;
      placebo following bunionectomy surgery&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Sum of Pain Intensity Differences (SPID) for the Primary pain measurement: VASPI (Visual&#xD;
      Analog Scale of Pain Intensity) from time 0 to 12 hrs; Safety evaluations assessed:&#xD;
      laboratory evaluations, physical examinations, vital signs/pulse oximetry and&#xD;
      electrocardiography&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2002</start_date>
  <completion_date type="Actual">February 2003</completion_date>
  <primary_completion_date type="Actual">February 2003</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>Other</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The Sum of Pain Intensity Differences (SPID) for the Visual Analog Scale Pain Intensity (VASPI)</measure>
    <time_frame>0-12 hours</time_frame>
  </primary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">241</enrollment>
  <condition>Postoperative Pain</condition>
  <arm_group>
    <arm_group_label>10 mg HC-ER</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Hydrocodone bitartrate extended release (HC-ER) 10 mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>20 mg HC-ER</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Hydrocodone bitartrate extended release (HC-ER) 20 mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>30 mg HC-ER</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Hydrocodone bitartrate extended release (HC-ER) 30 mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>40 mg HC-ER</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Hydrocodone bitartrate extended release (HC-ER) 40 mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>10 mg HC / 325 mg APAP</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>10 mg Hydrocodone (HC) / 325 mg acetaminophen (APAP)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Matching placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>10 mg HC-ER</intervention_name>
    <description>Single dose</description>
    <arm_group_label>10 mg HC-ER</arm_group_label>
    <other_name>ELN154088</other_name>
    <other_name>Hydrocodone bitartrate extended release (HC-ER)</other_name>
    <other_name>Zohydro Extended Release (ER)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>20 mg HC-ER</intervention_name>
    <description>Single dose</description>
    <arm_group_label>20 mg HC-ER</arm_group_label>
    <other_name>ELN154088</other_name>
    <other_name>Hydrocodone bitartrate extended release (HC-ER) 10 mg</other_name>
    <other_name>Zohydro Extended Release (ER)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>30 mg HC-ER</intervention_name>
    <description>Single dose</description>
    <arm_group_label>30 mg HC-ER</arm_group_label>
    <other_name>ELN154088</other_name>
    <other_name>Hydrocodone bitartrate extended release (HC-ER) 30 mg</other_name>
    <other_name>Zohydro Extended Release (ER)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>40 mg HC-ER</intervention_name>
    <description>Single dose</description>
    <arm_group_label>40 mg HC-ER</arm_group_label>
    <other_name>ELN154088</other_name>
    <other_name>Hydrocodone bitartrate extended release (HC-ER) 40 mg</other_name>
    <other_name>Zohydro Extended Release (ER)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>10 mg HC / 325 mg APAP</intervention_name>
    <description>Single dose</description>
    <arm_group_label>10 mg HC / 325 mg APAP</arm_group_label>
    <other_name>10 mg Hydrocodone (HC) / 325 mg acetaminophen (APAP)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Matching Placebo</intervention_name>
    <description>Single dose</description>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Placebo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject was able to read and voluntarily sign the Institutional Review Board (IRB)&#xD;
             approved, written informed consent document and given the opportunity to ask questions&#xD;
             regarding the study prior to the performance of any study- specific procedures.&#xD;
&#xD;
          -  Subject required primary unilateral first metatarsal bunionectomy surgery with or&#xD;
             without hammertoe repair with no other collateral procedures allowed&#xD;
&#xD;
          -  Subject was male or female at least 18 years of age.&#xD;
&#xD;
          -  Subject weighed &gt; or = 100 lbs (pounds).&#xD;
&#xD;
          -  Subject was willing and able to comply with the protocol and able to score their pain&#xD;
             intensity.&#xD;
&#xD;
          -  Subject was in good health as determined by the investigator on the basis of medical&#xD;
             history, physical examination, Electrocardiogram (ECG) and screening laboratory&#xD;
             results.&#xD;
&#xD;
          -  Subject had not developed a condition or complications as result of the bunionectomy&#xD;
             procedure that would preclude their participation in the study.&#xD;
&#xD;
          -  Subject was willing and able to remain at the recovery day care center for the entire&#xD;
             24-hour Treatment period.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject was pregnant or lactating.&#xD;
&#xD;
          -  Subject had been on an investigational drug within 30 days prior to the initiation of&#xD;
             study drug.&#xD;
&#xD;
          -  Subject had donated blood or blood components within one month prior to study&#xD;
             (Check-in).&#xD;
&#xD;
          -  Subject had a know allergy or hypersensitivity to opioids, acetaminophen, and/or&#xD;
             ketorolac.&#xD;
&#xD;
          -  Subject had a known history of substance or alcohol abuse within 2 years prior to&#xD;
             Screening.&#xD;
&#xD;
          -  Subject tested positive to drug screens (cocaine, marijuana, opioids, benzodiazepines,&#xD;
             and barbiturates) that could not be justified by prescription use.&#xD;
&#xD;
          -  Subject had a condition that would contraindicate the use of opioid analgesia (e.g.,&#xD;
             pulmonary disease or paralytic ileus).&#xD;
&#xD;
          -  Subject had received a selective serotonin reuptake inhibitor (SSRI), monoamine&#xD;
             oxidase inhibitor (MAOI) carbamazepine, quinidine, and/or tricyclic antidepressants&#xD;
             (TCA) compounds within 1-month prior to Check-in.&#xD;
&#xD;
          -  Subject had received opioids, tranquilizers, sedatives, or hypnotics within 48 hours&#xD;
             prior to Check-in.&#xD;
&#xD;
          -  Subject had received corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs),&#xD;
             or other analgesics within 24 hours prior to Check-in.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 21, 2014</study_first_submitted>
  <study_first_submitted_qc>July 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 22, 2014</study_first_posted>
  <last_update_submitted>November 8, 2022</last_update_submitted>
  <last_update_submitted_qc>November 8, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 10, 2022</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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acetaminophen</mesh_term>
    <mesh_term>Hydrocodone</mesh_term>
  </intervention_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/NCT02197156
org study id: ELN154088-201
nct id: NCT02197156
lead sponsor: 
has dmc: No
The purpose of the study is to establish a dose-response relationship among several capsule
      strengths of Hydrocodone Bitartrate Extended Release (HC-ER) and to compare the efficacy to
      placebo following bunionectomy surgery
Sum of Pain Intensity Differences (SPID) for the Primary pain measurement: VASPI (Visual
      Analog Scale of Pain Intensity) from time 0 to 12 hrs; Safety evaluations assessed:
      laboratory evaluations, physical examinations, vital signs/pulse oximetry and
      electrocardiography
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Double (Participant, Investigator)
measure: The Sum of Pain Intensity Differences (SPID) for the Visual Analog Scale Pain Intensity (VASPI)
time frame: 0-12 hours
arm group label: 10 mg HC-ER
arm group type: Experimental
description: Hydrocodone bitartrate extended release (HC-ER) 10 mg
arm group label: 20 mg HC-ER
arm group type: Experimental
description: Hydrocodone bitartrate extended release (HC-ER) 20 mg
arm group label: 30 mg HC-ER
arm group type: Experimental
description: Hydrocodone bitartrate extended release (HC-ER) 30 mg
arm group label: 40 mg HC-ER
arm group type: Experimental
description: Hydrocodone bitartrate extended release (HC-ER) 40 mg
arm group label: 10 mg HC / 325 mg APAP
arm group type: Active Comparator
description: 10 mg Hydrocodone (HC) / 325 mg acetaminophen (APAP)
arm group label: Placebo
arm group type: Placebo Comparator
description: Matching placebo
intervention type: Drug
intervention name: 10 mg HC-ER
description: Single dose
arm group label: 10 mg HC-ER
other name: ELN154088
other name: Hydrocodone bitartrate extended release (HC-ER)
other name: Zohydro Extended Release (ER)
intervention type: Drug
intervention name: 20 mg HC-ER
description: Single dose
arm group label: 20 mg HC-ER
other name: ELN154088
other name: Hydrocodone bitartrate extended release (HC-ER) 10 mg
other name: Zohydro Extended Release (ER)
intervention type: Drug
intervention name: 30 mg HC-ER
description: Single dose
arm group label: 30 mg HC-ER
other name: ELN154088
other name: Hydrocodone bitartrate extended release (HC-ER) 30 mg
other name: Zohydro Extended Release (ER)
intervention type: Drug
intervention name: 40 mg HC-ER
description: Single dose
arm group label: 40 mg HC-ER
other name: ELN154088
other name: Hydrocodone bitartrate extended release (HC-ER) 40 mg
other name: Zohydro Extended Release (ER)
intervention type: Drug
intervention name: 10 mg HC / 325 mg APAP
description: Single dose
arm group label: 10 mg HC / 325 mg APAP
other name: 10 mg Hydrocodone (HC) / 325 mg acetaminophen (APAP)
intervention type: Drug
intervention name: Matching Placebo
description: Single dose
arm group label: Placebo
other name: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Sponsor
mesh term: Pain, Postoperative
mesh term: Acetaminophen
mesh term: Hydrocodone