<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/NCT03246971</url>
  </required_header>
  <id_info>
    <org_study_id>KET010</org_study_id>
    <nct_id>NCT03246971</nct_id>
  </id_info>
  <brief_title>Study of Wafermine™ for Post-bunionectomy or Abdominoplasty Pain</brief_title>
  <official_title>A Phase 2, Multiple-Dose Study of The Efficacy and Safety of Wafermine™ (Sublingual Ketamine) in Participants Experiencing Acute Post-Operative Bunionectomy or Abdominoplasty Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>iX Biopharma Ltd.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>iX Biopharma Ltd.</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 evaluates the safety and effectiveness of Wafermine™ for post-bunionectomy or&#xD;
      post-abdominoplasty pain over a 24 hours period. For subjects undergoing bunionectomy, 2 out&#xD;
      of 3 subjects will receive Wafermine™ and 1 out of 3 subjects will receive placebo. For&#xD;
      subjects undergoing abdominoplasty, 3 out of 4 subjects will receive Wafermine™ and 1 out of&#xD;
      4 subjects will receive placebo.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 24, 2017</start_date>
  <completion_date type="Actual">July 17, 2018</completion_date>
  <primary_completion_date type="Actual">July 12, 2018</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>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Summed Pain Intensity Differences (SPID) using a Numerical Rating Scale</measure>
    <time_frame>12 hours</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">125</enrollment>
  <condition>Acute Pain</condition>
  <condition>Bunion</condition>
  <condition>Abdominoplasty</condition>
  <arm_group>
    <arm_group_label>Wafermine™</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Wafermine™ 50 mg</intervention_name>
    <description>Administered as needed for 12 hours</description>
    <arm_group_label>Wafermine™</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Wafermine™ 75 mg</intervention_name>
    <description>Administered as needed for 12 hours</description>
    <arm_group_label>Wafermine™</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebos</intervention_name>
    <description>Administered as needed for 12 hours</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Wafermine™ 25 mg</intervention_name>
    <description>Administered as needed for 12 hours</description>
    <arm_group_label>Wafermine™</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Scheduled for a bunionectomy or mini abdominoplasty with no additional planned&#xD;
             procedures.&#xD;
&#xD;
          -  Good general health without clinically significant renal, hepatic, cardiac or&#xD;
             respiratory disease, as determined by the Investigator.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  For those undergoing bunionectomy, other painful conditions involving the surgical&#xD;
             foot.&#xD;
&#xD;
          -  Positive lab values for Hepatitis B or C or HIV&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Lotus Clinical Research</name>
      <address>
        <city>Pasadena</city>
        <state>California</state>
        <zip>91105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>August 8, 2017</study_first_submitted>
  <study_first_submitted_qc>August 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2017</study_first_posted>
  <last_update_submitted>July 19, 2018</last_update_submitted>
  <last_update_submitted_qc>July 19, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 23, 2018</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>


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/NCT03246971
org study id: KET010
nct id: NCT03246971
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
This study evaluates the safety and effectiveness of Wafermine™ for post-bunionectomy or
      post-abdominoplasty pain over a 24 hours period. For subjects undergoing bunionectomy, 2 out
      of 3 subjects will receive Wafermine™ and 1 out of 3 subjects will receive placebo. For
      subjects undergoing abdominoplasty, 3 out of 4 subjects will receive Wafermine™ and 1 out of
      4 subjects will receive placebo.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Summed Pain Intensity Differences (SPID) using a Numerical Rating Scale
time frame: 12 hours
arm group label: Wafermine™
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: Wafermine™ 50 mg
description: Administered as needed for 12 hours
arm group label: Wafermine™
intervention type: Drug
intervention name: Wafermine™ 75 mg
description: Administered as needed for 12 hours
arm group label: Wafermine™
intervention type: Drug
intervention name: Placebos
description: Administered as needed for 12 hours
arm group label: Placebo
intervention type: Drug
intervention name: Wafermine™ 25 mg
description: Administered as needed for 12 hours
arm group label: Wafermine™
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor
mesh term: Acute Pain