<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/NCT01681966</url>
  </required_header>
  <id_info>
    <org_study_id>LNP-IL102</org_study_id>
    <nct_id>NCT01681966</nct_id>
  </id_info>
  <brief_title>A Single-dose Open-Label Study to Assess the Safety and Preliminary Efficacy of PRF 110 in Open Herniorrhaphy Surgery</brief_title>
  <official_title>A Single-dose, Open-Label, Multi-center Study to Assess the Safety and Preliminary Efficacy of PRF 110 (Formerly LNP) in Open Herniorrhaphy Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>PainReform LTD</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>PainReform LTD</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      LNP is new extended release (ER) oily solution formulation of ropivacaine that is intended&#xD;
      for local infiltration into surgical wounds. The purpose of this study is to determine the&#xD;
      ease of usage and administration of LNP in the surgical setting, to follow the&#xD;
      Pharmacokinetic (PK) profile of LNP over 72 hours and evaluate the duration of analgesia&#xD;
      witnessed in the surgical setting.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      LNP is new extended release (ER) oily solution formulation of ropivacaine that is intended&#xD;
      for local infiltration into surgical wounds. The formulation is designed to slowly release&#xD;
      the ropivacaine over 36-72 hours. By providing local analgesia over a long time span, the&#xD;
      need for systemic analgesics is expected to be reduced and hospital stays may be shortened.&#xD;
      The purpose of this study is to determine the ease of usage and administration of LNP in the&#xD;
      surgical setting, to follow the PK profile of LNP over 72 hours and evaluate the duration of&#xD;
      analgesia witnessed in the surgical setting.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">May 4, 2016</completion_date>
  <primary_completion_date type="Actual">May 4, 2016</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of treatment emergent adverse events (safety and tolerability).</measure>
    <time_frame>72 hours</time_frame>
    <description>All adverse events (AE) reported by the subjects will be recorded throughout the trial period</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Post-operative Pain intensity</measure>
    <time_frame>72 hours</time_frame>
    <description>Pain on a scale of 0-10 assessed at 0,1,2,4,8,12,24,36,48,60,72hrs post operation will be used to evaluate pain intensity</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Use of rescue medication</measure>
    <time_frame>72 hours</time_frame>
    <description>Overall use of rescue medication post operation</description>
  </other_outcome>
  <other_outcome>
    <measure>Maximum plasma concentration (Cmax)</measure>
    <time_frame>72 hrs</time_frame>
    <description>Samples will be collected at designated times up to 72hrs post drug application</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Post Operative Pain</condition>
  <arm_group>
    <arm_group_label>Application of PRF110- oily solution</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Post operative application of new extended release PRF110- oily solution (Ropivacaine)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PRF110- oily solution (Ropivacaine)</intervention_name>
    <description>Post operative application of PRF110-oily solution (Ropivacaine)</description>
    <arm_group_label>Application of PRF110- oily solution</arm_group_label>
    <other_name>Ropivacaine oily solution</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male subjects between 18-70 years of age who are scheduled to undergo open one sided&#xD;
             herniorrhaphy surgery;&#xD;
&#xD;
          -  Subjects have a BMI of less than 30 kg/m2;&#xD;
&#xD;
          -  Subjects are in good physical health (other than the need for the surgical procedure)&#xD;
             as judged by physical and laboratory examinations and have a negative urine based&#xD;
             screen for drugs of abuse;&#xD;
&#xD;
          -  Subjects must agree to refrain from ingesting any analgesic medication for at least 2&#xD;
             days (or 5 half-lives of the analgesic drug) prior to surgery; refrain from alcohol&#xD;
             and excessive caffeine intake on the day of surgery and during 72 hours after surgery;&#xD;
&#xD;
          -  Subject must be capable of reading, comprehending, and signing the informed consent&#xD;
             form;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with a history of melena or any significant hepatic, renal, endocrine,&#xD;
             cardiac, neurological, psychiatric, gastrointestinal, pulmonary, hematologic, or&#xD;
             metabolic disorders;&#xD;
&#xD;
          -  Subjects with a history of any type of cancer within 5 years of surgery;&#xD;
&#xD;
          -  Subjects with any history of alcohol or substance abuse;&#xD;
&#xD;
          -  Subjects that have a history of uncontrolled hypertension;&#xD;
&#xD;
          -  Subjects with a known hypersensitivity to any local anesthetic drug;&#xD;
&#xD;
          -  Subjects with a hemoglobin concentration of less than 10.0 g/dL;&#xD;
&#xD;
          -  Subjects with any clinically significant abnormal lab result (as judged by the&#xD;
             Principal Investigator);&#xD;
&#xD;
          -  Subjects with atrial fibrillation/flutter, an inserted pacemaker, or complete left&#xD;
             bundle branch block (LBBB) on ECG; or myocardial infarction within 6 months prior to&#xD;
             surgery;&#xD;
&#xD;
          -  Subjects with a clinically significant abnormal ECG at screening;&#xD;
&#xD;
          -  Subjects with any condition or history judged by the Investigator to place the subject&#xD;
             at increased risk;&#xD;
&#xD;
          -  Subjects judged by the Investigator to be unable or unwilling to comply with the&#xD;
             requirements of the protocol;&#xD;
&#xD;
          -  Subjects who have used an investigational drug within 30 days prior to entering the&#xD;
             study;&#xD;
&#xD;
          -  Subjects who have donated blood within 3 months prior to the start of the study;&#xD;
&#xD;
          -  Subjects who are members of the study site staff directly involved with the study or a&#xD;
             relative of the Sponsor or other personnel involved with the study;&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Moaad Farraj, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Galilee Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Western Galil Medical Center</name>
      <address>
        <city>Nahariya</city>
        <zip>2210001</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Assaf Harofeh Medical Center</name>
      <address>
        <city>Rishon LeZion</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sourasky Medical Center</name>
      <address>
        <city>Tel Aviv</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>September 5, 2012</study_first_submitted>
  <study_first_submitted_qc>September 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2012</study_first_posted>
  <last_update_submitted>November 12, 2020</last_update_submitted>
  <last_update_submitted_qc>November 12, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 16, 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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ropivacaine</mesh_term>
    <mesh_term>Pharmaceutical Solutions</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/NCT01681966
org study id: LNP-IL102
nct id: NCT01681966
lead sponsor: 
has dmc: No
LNP is new extended release (ER) oily solution formulation of ropivacaine that is intended
      for local infiltration into surgical wounds. The purpose of this study is to determine the
      ease of usage and administration of LNP in the surgical setting, to follow the
      Pharmacokinetic (PK) profile of LNP over 72 hours and evaluate the duration of analgesia
      witnessed in the surgical setting.
LNP is new extended release (ER) oily solution formulation of ropivacaine that is intended
      for local infiltration into surgical wounds. The formulation is designed to slowly release
      the ropivacaine over 36-72 hours. By providing local analgesia over a long time span, the
      need for systemic analgesics is expected to be reduced and hospital stays may be shortened.
      The purpose of this study is to determine the ease of usage and administration of LNP in the
      surgical setting, to follow the PK profile of LNP over 72 hours and evaluate the duration of
      analgesia witnessed in the surgical setting.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Incidence of treatment emergent adverse events (safety and tolerability).
time frame: 72 hours
description: All adverse events (AE) reported by the subjects will be recorded throughout the trial period
measure: Post-operative Pain intensity
time frame: 72 hours
description: Pain on a scale of 0-10 assessed at 0,1,2,4,8,12,24,36,48,60,72hrs post operation will be used to evaluate pain intensity
measure: Use of rescue medication
time frame: 72 hours
description: Overall use of rescue medication post operation
measure: Maximum plasma concentration (Cmax)
time frame: 72 hrs
description: Samples will be collected at designated times up to 72hrs post drug application
arm group label: Application of PRF110- oily solution
arm group type: Experimental
description: Post operative application of new extended release PRF110- oily solution (Ropivacaine)
intervention type: Drug
intervention name: PRF110- oily solution (Ropivacaine)
description: Post operative application of PRF110-oily solution (Ropivacaine)
arm group label: Application of PRF110- oily solution
other name: Ropivacaine oily solution
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Moaad Farraj, Dr.
role: Principal Investigator
affiliation: Galilee Medical Center
facility: 
facility: 
facility: 
country: Israel
responsible party type: Sponsor
mesh term: Pain, Postoperative
mesh term: Ropivacaine
mesh term: Pharmaceutical Solutions