<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/NCT02199678</url>
  </required_header>
  <id_info>
    <org_study_id>KET003</org_study_id>
    <nct_id>NCT02199678</nct_id>
  </id_info>
  <brief_title>A Study to Assess the Analgesic Properties of a Sublingual Wafer Formulation of Ketamine Following Third Molar Extraction</brief_title>
  <official_title>A Randomized,Double Blind, Parallel Group, Placebo Controlled Dose Ranging Study to Assess the Analgesic Efficacy, Tolerability, Safety and Pharmacokinetic/Pharmacodynamic Properties of a Sublingual Wafer Formulation of Ketamine Following Third Molar Extraction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lotus Clinical Research, LLC</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>iX Biopharma Ltd.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Lotus Clinical Research, LLC</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a Phase 2, randomized, multicenter, parallel group, double-blind, dose-ranging,&#xD;
      placebo-controlled evaluation of the analgesic efficacy, safety and pharmacokinetics of&#xD;
      ketamine sublingual wafer in adult subjects who experience post operative pain after&#xD;
      undergoing third molar extraction.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">November 2014</completion_date>
  <primary_completion_date type="Actual">November 2014</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Sum of Pain Intensity Difference</measure>
    <time_frame>3 hours</time_frame>
    <description>The primary objective of this study is to demonstrate the dose-response relationship for analgesia of three dose levels of ketamine sublingual wafer compared with placebo, using the summed pain intensity difference from baseline over the first 3 hours (SPID3) in subjects with acute moderate to severe pain following third molar extraction.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sum of Pain Intensity Difference</measure>
    <time_frame>6 hours</time_frame>
    <description>SPID 6</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety and tolerability</measure>
    <time_frame>6 hours</time_frame>
    <description>Safety and tolerability of ketamine sublingual wafer as evaluated with physical examination, vital signs, pulse oximetry, clinical laboratory tests, ECGs, and incidence of Adverse Events (AEs) and Serious AEs (SAEs)</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ketamine 25 mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>ketamine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ketamine 35 mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>ketamine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ketamine 50 mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>ketamine</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>placebo</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ketamine 25 mg</intervention_name>
    <description>ketamine</description>
    <arm_group_label>ketamine 25 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ketamine 35 mg</intervention_name>
    <description>ketamine</description>
    <arm_group_label>ketamine 35 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ketamine 50 mg</intervention_name>
    <description>ketamine</description>
    <arm_group_label>ketamine 50 mg</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        18- 38 years of age Scheduled to undergo two ipsilateral third molar extractions&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>38 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Lotus Clinical Research, LLC</name>
      <address>
        <city>Pasadena</city>
        <state>California</state>
        <zip>91105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Prahealthsciences</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 23, 2014</study_first_submitted>
  <study_first_submitted_qc>July 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 24, 2014</study_first_posted>
  <last_update_submitted>November 19, 2014</last_update_submitted>
  <last_update_submitted_qc>November 19, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 21, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ketamine</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/NCT02199678
org study id: KET003
nct id: NCT02199678
lead sponsor: 
collaborator: 
has dmc: No
This is a Phase 2, randomized, multicenter, parallel group, double-blind, dose-ranging,
      placebo-controlled evaluation of the analgesic efficacy, safety and pharmacokinetics of
      ketamine sublingual wafer in adult subjects who experience post operative pain after
      undergoing third molar extraction.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Sum of Pain Intensity Difference
time frame: 3 hours
description: The primary objective of this study is to demonstrate the dose-response relationship for analgesia of three dose levels of ketamine sublingual wafer compared with placebo, using the summed pain intensity difference from baseline over the first 3 hours (SPID3) in subjects with acute moderate to severe pain following third molar extraction.
measure: Sum of Pain Intensity Difference
time frame: 6 hours
description: SPID 6
measure: Safety and tolerability
time frame: 6 hours
description: Safety and tolerability of ketamine sublingual wafer as evaluated with physical examination, vital signs, pulse oximetry, clinical laboratory tests, ECGs, and incidence of Adverse Events (AEs) and Serious AEs (SAEs)
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo
arm group label: ketamine 25 mg
arm group type: Active Comparator
description: ketamine
arm group label: ketamine 35 mg
arm group type: Active Comparator
description: ketamine
arm group label: ketamine 50 mg
arm group type: Active Comparator
description: ketamine
intervention type: Drug
intervention name: Placebo
description: placebo
arm group label: Placebo
intervention type: Drug
intervention name: ketamine 25 mg
description: ketamine
arm group label: ketamine 25 mg
intervention type: Drug
intervention name: ketamine 35 mg
description: ketamine
arm group label: ketamine 35 mg
intervention type: Drug
intervention name: ketamine 50 mg
description: ketamine
arm group label: ketamine 50 mg
criteria: 
gender: All
minimum age: 18 Years
maximum age: 38 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Ketamine