<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/NCT02187588</url>
  </required_header>
  <id_info>
    <org_study_id>1120.3</org_study_id>
    <nct_id>NCT02187588</nct_id>
  </id_info>
  <brief_title>Study to Assess the Kinetic of the Analgesic Effect and Tolerability of Eschscholtzia Californica Versus Ibuprofen and Placebo in the Treatment of Pain After Surgery of the Third Molar</brief_title>
  <official_title>Short Term Double Blind Randomised Controlled Study to Assess the Kinetic of the Analgesic Effect and the Tolerability of Eschscholtzia Californica 500 mg and 1000 mg Versus Ibuprofen 200 mg and Placebo in the Treatment of Pain After Surgery of the Third Molar</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      Study to determine the kinetic of the analgesic effect of 500 mg and 1000 mg of Eschscholtzia&#xD;
      Californica per os and placebo in patients undergoing dental surgery over an observation&#xD;
      period of 6 hours. In a secondary analysis, kinetic of analgesic effect comparison between&#xD;
      Eschscholtzia californica 500 mg, 1000 mg and Ibuprofen 200 mg&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 1998</start_date>
  <primary_completion_date type="Actual">May 1999</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>Double</masking>
  </study_design_info>
  <primary_outcome>
    <measure>VAS-SPID - summed pain intensity differences (SPID) on a VAS (Visual Analogue Scale)</measure>
    <time_frame>Baseline, up to 6 hours after drug intake</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain intensity differences (PID) on a VAS</measure>
    <time_frame>Baseline, up to 6 hours after drug intake</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain intensity difference in the groups on a VAS</measure>
    <time_frame>Baseline, 2 hours after drug intake</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time point for maximum pain intensity difference on VAS</measure>
    <time_frame>Baseline, up to 6 hours after drug intake</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with a pain decrease of at least 50 % over the all period of observation on a VAS</measure>
    <time_frame>Baseline, up to 6 hours after drug intake</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain relief at each observed time points on a 5-point verbal rating scale (VRS)</measure>
    <time_frame>up to 6 hours after drug intake</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total pain relief on a 5-point VRS</measure>
    <time_frame>up to 6 hours after drug intake</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global efficacy assessment on a 4-points VRS</measure>
    <time_frame>2 and 6 hours after drug intake, day 7</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients requiring a rescue medication</measure>
    <time_frame>Day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>up to 9 days after treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of tolerability by investigator on a 4-point VRS</measure>
    <time_frame>6 hours after drug intake, day 7</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of tolerability by subject on a 4-point VRS</measure>
    <time_frame>6 hours after drug intake, day 7</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">200</enrollment>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>Eschscholtzia Californica - low dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Eschscholtzia Californica - high dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Ibuprofen</arm_group_label>
    <arm_group_type>Active Comparator</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>Eschscholtzia Californica - low dose</intervention_name>
    <arm_group_label>Eschscholtzia Californica - low dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Eschscholtzia Californica - high dose</intervention_name>
    <arm_group_label>Eschscholtzia Californica - high dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ibuprofen</intervention_name>
    <arm_group_label>Ibuprofen</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Eschscholtzia Californica - low dose Placebo</intervention_name>
    <arm_group_label>Eschscholtzia Californica - low dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Eschscholtzia Californica - high dose Placebo</intervention_name>
    <arm_group_label>Ibuprofen</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ibuprofen Placebo</intervention_name>
    <arm_group_label>Eschscholtzia Californica - high dose</arm_group_label>
    <arm_group_label>Eschscholtzia Californica - low dose</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female above 18 or below 61 years old&#xD;
&#xD;
          -  Patient having to undergo a third molar removal from the lower jaw under local&#xD;
             troncular anesthesia (articaine + adrenaline)&#xD;
&#xD;
          -  Type of inclusion of the molar:&#xD;
&#xD;
               -  Molar in the sub-mucosa: Type II&#xD;
&#xD;
               -  Molar partially impacted in the bone: Type III&#xD;
&#xD;
          -  Patient suffering from at least moderate to severe pain after surgical removal of an&#xD;
             impacted third molar, defined by a 4 point verbal rating scale&#xD;
&#xD;
          -  Patient's informed consent in accordance with the French legislation&#xD;
&#xD;
          -  Patient affiliated to the Social Security System&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or nursing female or female of childbearing potential not using a medically&#xD;
             approved method of contraception like oral contraception or intrauterine contraceptive&#xD;
             device&#xD;
&#xD;
          -  Patient with any pathology inducing a chronic pain&#xD;
&#xD;
          -  Patient having taken any drug with analgesic properties in the 24 hours previous to&#xD;
             the administration of the study drug&#xD;
&#xD;
          -  Patient with concomitant administration of other Non-Steroid Anti-Inflammatory Drug(s)&#xD;
             (NSAIDs) or analgesic agents&#xD;
&#xD;
          -  Patients treated by an antibiotic different from those required for the dental surgery&#xD;
             which administration is started 48 hours prior to the tooth removal&#xD;
&#xD;
          -  Patient with significant peri-operative complication judged by the investigator&#xD;
&#xD;
          -  Patient with anti-coagulants concomitant treatment (including heparin)&#xD;
&#xD;
          -  Patient with severe hepatic or renal insufficiency which judged to be regarded as&#xD;
             clinically relevant by the investigator or any known clinically significant disease&#xD;
             which may induce a risk for the patient in participating to the trial&#xD;
&#xD;
          -  Patient with mental disturbance&#xD;
&#xD;
          -  Patient with non controlled diabetes&#xD;
&#xD;
          -  Patient with acute infections&#xD;
&#xD;
          -  Patient with respiratory insufficiency, asthma&#xD;
&#xD;
          -  Patient unable to comply with the protocol&#xD;
&#xD;
          -  Patient having taken part in a clinical trial in the past month or already&#xD;
             participating in another trial&#xD;
&#xD;
          -  Patient deprived of their freedom by a judicial or administrative decision&#xD;
&#xD;
          -  Adults under guardianship&#xD;
&#xD;
          -  Persons hospitalized in medical or social establishments&#xD;
&#xD;
          -  Patients in emergency situation&#xD;
&#xD;
          -  Patient with a known or suspected hypersensitivity to the trial medication, to&#xD;
             Ibuprofen, Paracetamol, anesthetic used (articaine, adrenaline), to the preventive&#xD;
             antibiotic treatment (penicillin, macrolides)&#xD;
&#xD;
        Post study exclusion period: the patient will not be able to participate in any other trial&#xD;
        for a period of two weeks after the end of this trial&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <link>
    <url>http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1120/1120.3_U00-0017.pdf</url>
    <description>Related Info</description>
  </link>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 10, 2014</study_first_submitted>
  <study_first_submitted_qc>July 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 11, 2014</study_first_posted>
  <last_update_submitted>July 11, 2014</last_update_submitted>
  <last_update_submitted_qc>July 11, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 14, 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>Ibuprofen</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/NCT02187588
org study id: 1120.3
nct id: NCT02187588
lead sponsor: 
Study to determine the kinetic of the analgesic effect of 500 mg and 1000 mg of Eschscholtzia
      Californica per os and placebo in patients undergoing dental surgery over an observation
      period of 6 hours. In a secondary analysis, kinetic of analgesic effect comparison between
      Eschscholtzia californica 500 mg, 1000 mg and Ibuprofen 200 mg
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double
measure: VAS-SPID - summed pain intensity differences (SPID) on a VAS (Visual Analogue Scale)
time frame: Baseline, up to 6 hours after drug intake
measure: Pain intensity differences (PID) on a VAS
time frame: Baseline, up to 6 hours after drug intake
measure: Pain intensity difference in the groups on a VAS
time frame: Baseline, 2 hours after drug intake
measure: Time point for maximum pain intensity difference on VAS
time frame: Baseline, up to 6 hours after drug intake
measure: Number of patients with a pain decrease of at least 50 % over the all period of observation on a VAS
time frame: Baseline, up to 6 hours after drug intake
measure: Pain relief at each observed time points on a 5-point verbal rating scale (VRS)
time frame: up to 6 hours after drug intake
measure: Total pain relief on a 5-point VRS
time frame: up to 6 hours after drug intake
measure: Global efficacy assessment on a 4-points VRS
time frame: 2 and 6 hours after drug intake, day 7
measure: Number of patients requiring a rescue medication
time frame: Day 1
measure: Number of patients with adverse events
time frame: up to 9 days after treatment
measure: Assessment of tolerability by investigator on a 4-point VRS
time frame: 6 hours after drug intake, day 7
measure: Assessment of tolerability by subject on a 4-point VRS
time frame: 6 hours after drug intake, day 7
arm group label: Eschscholtzia Californica - low dose
arm group type: Experimental
arm group label: Eschscholtzia Californica - high dose
arm group type: Experimental
arm group label: Ibuprofen
arm group type: Active Comparator
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: Eschscholtzia Californica - low dose
arm group label: Eschscholtzia Californica - low dose
intervention type: Drug
intervention name: Eschscholtzia Californica - high dose
arm group label: Eschscholtzia Californica - high dose
intervention type: Drug
intervention name: Ibuprofen
arm group label: Ibuprofen
intervention type: Drug
intervention name: Eschscholtzia Californica - low dose Placebo
arm group label: Eschscholtzia Californica - low dose
intervention type: Drug
intervention name: Eschscholtzia Californica - high dose Placebo
arm group label: Ibuprofen
arm group label: Placebo
intervention type: Drug
intervention name: Ibuprofen Placebo
arm group label: Eschscholtzia Californica - high dose
arm group label: Eschscholtzia Californica - low dose
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
url: http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1120/1120.3_U00-0017.pdf
description: Related Info
responsible party type: Sponsor
mesh term: Ibuprofen