<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/NCT02232178</url>
  </required_header>
  <id_info>
    <org_study_id>INN-CB-013</org_study_id>
    <nct_id>NCT02232178</nct_id>
  </id_info>
  <brief_title>Pharmacokinetics, Relative Bioavailability and Safety of Xaracoll Implant</brief_title>
  <official_title>A Randomized, Blinded, Inpatient Study to Investigate the PK, Relative Bioavailability and Safety of 2 Doses of XaraColl (200 and 300 mg Bupivacaine HCl) Compared to Bupivacaine HCl Infiltration (150 mg) After Open Laparotomy Hernioplasty</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Innocoll</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Premier Research Group plc</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Innocoll</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Assess the pharmacokinetic profile of 2 doses of the XaraColl® implant after open laparotomy&#xD;
      hernioplasty and assess the relative bioavailability of Xaracoll compared to a local&#xD;
      bupivacaine infiltration.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Inguinal hernioplasty is a common surgery. Common surgical methods used include laparoscopic&#xD;
      and open placement of synthetic mesh. Managing postoperative pain and preventing morbidity&#xD;
      after open mesh hernioplasty remain considerable medical challenges.&#xD;
&#xD;
      Bupivacaine is a local anesthetic (pain medicine) that has an established safety profile.&#xD;
      Collagen is a protein that is found in all mammals. The Xaracoll implant is a thin flat&#xD;
      sponge made out of collagen that comes from cow tendons and contains bupivacaine. When&#xD;
      inserted into a surgical site, the collagen breaks down and bupivacaine is released at the&#xD;
      surgical site to provide postoperative pain control.&#xD;
&#xD;
      This study will assess the pharmacokinetic profile of 2 doses of the XaraColl implant after&#xD;
      open laparotomy hernioplasty and assess the relative bioavailability of the Xaracoll implant&#xD;
      compared to a local bupivacaine infiltration.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 20, 2014</start_date>
  <completion_date type="Actual">March 23, 2015</completion_date>
  <primary_completion_date type="Actual">February 23, 2015</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cmax</measure>
    <time_frame>0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 72, and 96 hours after surgery.</time_frame>
    <description>Maximum drug plasma concentration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC0-last</measure>
    <time_frame>0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 72, and 96 hours after surgery.</time_frame>
    <description>Area under the plasma concentration-time curve from Time 0 to time of last quantifiable plasma concentration.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tmax</measure>
    <time_frame>0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 72, and 96 hours after surgery.</time_frame>
    <description>Time to maximum plasma concentration.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>t1/2 (Hour)</measure>
    <time_frame>0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 72, and 96 hours after surgery.</time_frame>
    <description>Terminal half-life.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">64</enrollment>
  <condition>Hernioplasty</condition>
  <arm_group>
    <arm_group_label>2 100mg Xaracoll implants</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Bupivacaine HCl implant</description>
  </arm_group>
  <arm_group>
    <arm_group_label>3 100mg Xaracoll implants</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Bupivacaine HCl implant</description>
  </arm_group>
  <arm_group>
    <arm_group_label>150mg Bupivacaine HCl injection</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Bupivacaine HCl</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>2 100mg Xaracoll implants</intervention_name>
    <arm_group_label>2 100mg Xaracoll implants</arm_group_label>
    <other_name>Bupivacaine HCl implant</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>3 100mg Xaracoll implants</intervention_name>
    <arm_group_label>3 100mg Xaracoll implants</arm_group_label>
    <other_name>Bupivacaine HCl implant</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>150mg Bupivacaine HCl injection</intervention_name>
    <arm_group_label>150mg Bupivacaine HCl injection</arm_group_label>
    <other_name>Bupivacaine HCl</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Man or woman who is ≥ 18 years of age&#xD;
&#xD;
          2. Has a planned unilateral inguinal hernioplasty (open laparotomy, tension free&#xD;
             technique)&#xD;
&#xD;
          3. If female, is nonpregnant&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Scheduled for bilateral inguinal hernioplasty or other significant concomitant&#xD;
             surgical procedures&#xD;
&#xD;
          2. Has undergone major surgery within 3 months of the scheduled hernioplasty or plans to&#xD;
             undergo another laparotomy procedure within 30 days postoperatively&#xD;
&#xD;
          3. Has any clinically significant unstable cardiac, neurological, immunological, renal,&#xD;
             hepatic or hematological disease or any other condition that, in the opinion of the&#xD;
             investigator, could compromise the patient's welfare, ability to communicate with the&#xD;
             study staff or otherwise contraindicate study participation&#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>Gwendolyn Niebler, D.O.</last_name>
    <role>Study Director</role>
    <affiliation>Innocoll</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Pinnacle Research Group</name>
      <address>
        <city>Anniston</city>
        <state>Alabama</state>
        <zip>36207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shoals Medical Trials</name>
      <address>
        <city>Sheffield</city>
        <state>Alabama</state>
        <zip>35660</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wexner Medical Center at Ohio State University</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>First Surgical Hospital</name>
      <address>
        <city>Bellaire</city>
        <state>Texas</state>
        <zip>77401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Victory Hospital</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77704</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>September 3, 2014</study_first_submitted>
  <study_first_submitted_qc>September 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 5, 2014</study_first_posted>
  <results_first_submitted>March 17, 2017</results_first_submitted>
  <results_first_submitted_qc>July 25, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">August 23, 2018</results_first_posted>
  <last_update_submitted>September 29, 2020</last_update_submitted>
  <last_update_submitted_qc>September 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 20, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>unilateral inguinal hernioplasty</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bupivacaine</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>2 100mg Xaracoll Implants</title>
          <description>Bupivacaine HCl implant&#xD;
2 100mg Xaracoll implants</description>
        </group>
        <group group_id="P2">
          <title>3 100mg Xaracoll Implants</title>
          <description>Bupivacaine HCl implant&#xD;
3 100mg Xaracoll implants</description>
        </group>
        <group group_id="P3">
          <title>150mg Bupivacaine HCl Injection</title>
          <description>Bupivacaine HCl&#xD;
150mg Bupivacaine HCl injection</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="26"/>
                <participants group_id="P2" count="25"/>
                <participants group_id="P3" count="13"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Per Protocol PK Population</title>
              <participants_list>
                <participants group_id="P1" count="26"/>
                <participants group_id="P2" count="24"/>
                <participants group_id="P3" count="11"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Safety Population</title>
              <participants_list>
                <participants group_id="P1" count="26"/>
                <participants group_id="P2" count="24"/>
                <participants group_id="P3" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
                <participants group_id="P2" count="24"/>
                <participants group_id="P3" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>ineligibility</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>surgical complication</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>all randomized population</population>
      <group_list>
        <group group_id="B1">
          <title>2 100mg Xaracoll Implants</title>
          <description>Bupivacaine HCl implant&#xD;
2 100mg Xaracoll implants</description>
        </group>
        <group group_id="B2">
          <title>3 100mg Xaracoll Implants</title>
          <description>Bupivacaine HCl implant&#xD;
3 100mg Xaracoll implants</description>
        </group>
        <group group_id="B3">
          <title>150mg Bupivacaine HCl Injection</title>
          <description>Bupivacaine HCl&#xD;
150mg Bupivacaine HCl injection</description>
        </group>
        <group group_id="B4">
          <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="26"/>
            <count group_id="B2" value="25"/>
            <count group_id="B3" value="13"/>
            <count group_id="B4" value="64"/>
          </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="42.7" spread="11.93"/>
                    <measurement group_id="B2" value="46.1" spread="11.40"/>
                    <measurement group_id="B3" value="48.2" spread="12.76"/>
                    <measurement group_id="B4" value="45.2" spread="11.90"/>
                  </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="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="12"/>
                    <measurement group_id="B4" value="61"/>
                  </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>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="13"/>
                    <measurement group_id="B4" value="64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Cmax</title>
        <description>Maximum drug plasma concentration</description>
        <time_frame>0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 72, and 96 hours after surgery.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>2 100mg Xaracoll Implants</title>
            <description>Bupivacaine HCl implant&#xD;
2 100mg Xaracoll implants</description>
          </group>
          <group group_id="O2">
            <title>3 100mg Xaracoll Implants</title>
            <description>Bupivacaine HCl implant&#xD;
3 100mg Xaracoll implants</description>
          </group>
          <group group_id="O3">
            <title>150mg Bupivacaine HCl Injection</title>
            <description>Bupivacaine HCl&#xD;
150mg Bupivacaine HCl injection</description>
          </group>
        </group_list>
        <measure>
          <title>Cmax</title>
          <description>Maximum drug plasma concentration</description>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
                <count group_id="O2" value="24"/>
                <count group_id="O3" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="340.4" spread="111.05"/>
                    <measurement group_id="O2" value="524.8" spread="146.45"/>
                    <measurement group_id="O3" value="348.4" spread="184.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>AUC0-last</title>
        <description>Area under the plasma concentration-time curve from Time 0 to time of last quantifiable plasma concentration.</description>
        <time_frame>0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 72, and 96 hours after surgery.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>2 100mg Xaracoll Implants</title>
            <description>Bupivacaine HCl implant&#xD;
2 100mg Xaracoll implants</description>
          </group>
          <group group_id="O2">
            <title>3 100mg Xaracoll Implants</title>
            <description>Bupivacaine HCl implant&#xD;
3 100mg Xaracoll implants</description>
          </group>
          <group group_id="O3">
            <title>150mg Bupivacaine HCl Injection</title>
            <description>Bupivacaine HCl&#xD;
150mg Bupivacaine HCl injection</description>
          </group>
        </group_list>
        <measure>
          <title>AUC0-last</title>
          <description>Area under the plasma concentration-time curve from Time 0 to time of last quantifiable plasma concentration.</description>
          <units>ng/mL∙hr</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
                <count group_id="O2" value="24"/>
                <count group_id="O3" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10793.449" spread="5523.4326"/>
                    <measurement group_id="O2" value="18589.907" spread="7841.1973"/>
                    <measurement group_id="O3" value="8323.188" spread="4312.1940"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Tmax</title>
        <description>Time to maximum plasma concentration.</description>
        <time_frame>0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 72, and 96 hours after surgery.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>2 100mg Xaracoll Implants</title>
            <description>Bupivacaine HCl implant&#xD;
2 100mg Xaracoll implants</description>
          </group>
          <group group_id="O2">
            <title>3 100mg Xaracoll Implants</title>
            <description>Bupivacaine HCl implant&#xD;
3 100mg Xaracoll implants</description>
          </group>
          <group group_id="O3">
            <title>150mg Bupivacaine HCl Injection</title>
            <description>Bupivacaine HCl&#xD;
150mg Bupivacaine HCl injection</description>
          </group>
        </group_list>
        <measure>
          <title>Tmax</title>
          <description>Time to maximum plasma concentration.</description>
          <units>hours</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
                <count group_id="O2" value="24"/>
                <count group_id="O3" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.271" spread="10.8603"/>
                    <measurement group_id="O2" value="8.567" spread="10.2484"/>
                    <measurement group_id="O3" value="8.783" spread="01.8761"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>t1/2 (Hour)</title>
        <description>Terminal half-life.</description>
        <time_frame>0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 72, and 96 hours after surgery.</time_frame>
        <population>Per protocol PK population.</population>
        <group_list>
          <group group_id="O1">
            <title>2 100mg Xaracoll Implants</title>
            <description>Bupivacaine HCl implant&#xD;
2 100mg Xaracoll implants</description>
          </group>
          <group group_id="O2">
            <title>3 100mg Xaracoll Implants</title>
            <description>Bupivacaine HCl implant&#xD;
3 100mg Xaracoll implants</description>
          </group>
          <group group_id="O3">
            <title>150mg Bupivacaine HCl Injection</title>
            <description>Bupivacaine HCl&#xD;
150mg Bupivacaine HCl injection</description>
          </group>
        </group_list>
        <measure>
          <title>t1/2 (Hour)</title>
          <description>Terminal half-life.</description>
          <population>Per protocol PK population.</population>
          <units>hours</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
                <count group_id="O2" value="24"/>
                <count group_id="O3" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.922" spread="7.6260"/>
                    <measurement group_id="O2" value="18.058" spread="7.6699"/>
                    <measurement group_id="O3" value="8.819" spread="4.5292"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>30 days</time_frame>
      <group_list>
        <group group_id="E1">
          <title>2 100mg Xaracoll Implants</title>
          <description>Bupivacaine HCl implant&#xD;
2 100mg Xaracoll implants</description>
        </group>
        <group group_id="E2">
          <title>3 100mg Xaracoll Implants</title>
          <description>Bupivacaine HCl implant&#xD;
3 100mg Xaracoll implants</description>
        </group>
        <group group_id="E3">
          <title>150mg Bupivacaine HCl Injection</title>
          <description>Bupivacaine HCl&#xD;
150mg Bupivacaine HCl injection</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA (Unspecified)</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="21" subjects_at_risk="26"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>bradycardia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>ventricular extrasystoles</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>constipation</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="26"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="24"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>nausea</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="26"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>abdominal distention</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>diarrhoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>dyspepsia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>hypoaesthesia oral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>inguinal hernia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>paraesthesia oral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>toothache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>vomiting</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>catheter site pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>catheter site erythema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>local swelling</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>oedema peripheral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>wound infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>tooth abscess</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>incision site haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="24"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>post procedural oedema</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="26"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="24"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>procedural hypotension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="24"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>incision site erythema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>incision site haematoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>incision site pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>procedural pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>seroma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>wound complication</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>wound dehiscence</sub_title>
                <description>Separation of the edges of the wound. There was no evidence of loss of fascial integrity.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>wound haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>wound secretion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>blood pressure increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>musculoskeletal stiffness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>somnolence</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="26"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="24"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>dizziness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>dysgeusia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>headache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>anxiety</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>dysuria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>penile haemorrhage</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="26"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>testicular pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="26"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>benign prostatic hyperplasia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>genital haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>scrotal oedema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>scrotal swelling</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>testicular oedema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>testicular swelling</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>respiratory distress</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>sneezing</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>ecchymosis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="26"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>hyperhidrosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>rash</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>incisional drainage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>post procedural drainage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>hypertension</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="26"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="24"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
              </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>results of the multicenter study had to be published prior to the publication of any site specific data.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Charlene A. Tucker, MS Executive Director, Medical Writing and Document Management</name_or_title>
      <organization>Innocoll</organization>
      <phone>484-406-5211</phone>
      <email>ctucker@innocoll.com</email>
    </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/NCT02232178
org study id: INN-CB-013
nct id: NCT02232178
lead sponsor: 
collaborator: 
has dmc: No
Assess the pharmacokinetic profile of 2 doses of the XaraColl® implant after open laparotomy
      hernioplasty and assess the relative bioavailability of Xaracoll compared to a local
      bupivacaine infiltration.
Inguinal hernioplasty is a common surgery. Common surgical methods used include laparoscopic
      and open placement of synthetic mesh. Managing postoperative pain and preventing morbidity
      after open mesh hernioplasty remain considerable medical challenges.

      Bupivacaine is a local anesthetic (pain medicine) that has an established safety profile.
      Collagen is a protein that is found in all mammals. The Xaracoll implant is a thin flat
      sponge made out of collagen that comes from cow tendons and contains bupivacaine. When
      inserted into a surgical site, the collagen breaks down and bupivacaine is released at the
      surgical site to provide postoperative pain control.

      This study will assess the pharmacokinetic profile of 2 doses of the XaraColl implant after
      open laparotomy hernioplasty and assess the relative bioavailability of the Xaracoll implant
      compared to a local bupivacaine infiltration.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Cmax
time frame: 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 72, and 96 hours after surgery.
description: Maximum drug plasma concentration
measure: AUC0-last
time frame: 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 72, and 96 hours after surgery.
description: Area under the plasma concentration-time curve from Time 0 to time of last quantifiable plasma concentration.
measure: Tmax
time frame: 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 72, and 96 hours after surgery.
description: Time to maximum plasma concentration.
measure: t1/2 (Hour)
time frame: 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 72, and 96 hours after surgery.
description: Terminal half-life.
arm group label: 2 100mg Xaracoll implants
arm group type: Experimental
description: Bupivacaine HCl implant
arm group label: 3 100mg Xaracoll implants
arm group type: Experimental
description: Bupivacaine HCl implant
arm group label: 150mg Bupivacaine HCl injection
arm group type: Active Comparator
description: Bupivacaine HCl
intervention type: Drug
intervention name: 2 100mg Xaracoll implants
arm group label: 2 100mg Xaracoll implants
other name: Bupivacaine HCl implant
intervention type: Drug
intervention name: 3 100mg Xaracoll implants
arm group label: 3 100mg Xaracoll implants
other name: Bupivacaine HCl implant
intervention type: Drug
intervention name: 150mg Bupivacaine HCl injection
arm group label: 150mg Bupivacaine HCl injection
other name: Bupivacaine HCl
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Gwendolyn Niebler, D.O.
role: Study Director
affiliation: Innocoll
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Bupivacaine
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 