<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/NCT01706588</url>
  </required_header>
  <id_info>
    <org_study_id>12UK/DCsc04</org_study_id>
    <nct_id>NCT01706588</nct_id>
  </id_info>
  <brief_title>Injectable Diclofenac for the Prevention of Post-operative Dental Pain</brief_title>
  <acronym>DP4</acronym>
  <official_title>Preliminary Evaluation of the Efficacy and Local Tolerability of Injectable Diclofenac at 5, 12.5, 25 and 50 mg/mL, Administered Locally Prior to Surgery for the Prevention of Post-operative Pain After Third Molar Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>IBSA Institut Biochimique SA</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>IBSA Institut Biochimique SA</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective, randomised, double-blind, placebo-controlled, parallel group study in&#xD;
      approximately 75 patients undergoing surgical removal of an impacted lower third molar.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">May 2013</completion_date>
  <primary_completion_date type="Actual">May 2013</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 (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Area Under the Curve (AUC) of the Pain Scores.</measure>
    <time_frame>Pain scores will be measured over the time from end of surgery (time 0) to the 6 hour post-surgery</time_frame>
    <description>Pain will be scored by the patient at the end of surgery (time 0) and at 15-minute intervals after surgery for a total of 6 hours on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Postsurgical Extra-oral Swelling</measure>
    <time_frame>measured at 6 hours postsurgery, at day 3 and 1 week postsurgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Trismus</measure>
    <time_frame>measured at 6 hours postsurgery, at day 3 and 1 week postsurgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peak Pain Intensity</measure>
    <time_frame>measured from end of surgery up to 12 hours postsurgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to First Use of Rescue Medication.</measure>
    <time_frame>measured from end of surgery up to 1 week postsurgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Amount of Rescue Medication</measure>
    <time_frame>consumed by the patient every 15-minutes postsurgery up to 6 hours postsurgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rescue Medication Consumption</measure>
    <time_frame>consumed by the patient from end of surgery up to 24 and up to 48 hours postsurgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient and Investigator Global Evaluation of the Effectiveness of Treatment</measure>
    <time_frame>at 6 hour postsurgery and on Day 3</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Onset of Pain</measure>
    <time_frame>measured from end of surgery up to 12 hours postsurgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wound Healing</measure>
    <time_frame>at 6 hour postsurgery, and on day 3 and 1 week postsurgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recurrent Bleeding</measure>
    <time_frame>every hour up to 6 hour postsurgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vital Signs</measure>
    <time_frame>presurgery (within 30 days from surgery), at day of surgery (day 1), day 3 and 1 week postsurgery.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Patients With Adverse Events</measure>
    <time_frame>from signature of the informed consent to 1 week postsurgery</time_frame>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">75</enrollment>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>Diclofenac sodium 5 mg/mL</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Diclofenac sodium 12.5 mg/mL</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Diclofenac sodium 25 mg/mL</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Diclofenac sodium 50 mg/mL</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo 1 mL</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Diclofenac sodium</intervention_name>
    <description>One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.</description>
    <arm_group_label>Diclofenac sodium 12.5 mg/mL</arm_group_label>
    <arm_group_label>Diclofenac sodium 25 mg/mL</arm_group_label>
    <arm_group_label>Diclofenac sodium 5 mg/mL</arm_group_label>
    <arm_group_label>Diclofenac sodium 50 mg/mL</arm_group_label>
    <arm_group_label>Placebo 1 mL</arm_group_label>
    <other_name>Diclofenac HPBCD</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Out-patients of either gender.&#xD;
&#xD;
          2. Patients aged ≥ 18 to ≤ 65 years old.&#xD;
&#xD;
          3. Subjects able and willing to give their written consent prior to inclusion in the&#xD;
             study.&#xD;
&#xD;
          4. Female subjects of childbearing potential must (1) have a negative urine pregnancy&#xD;
             test at the inclusion visit, (2) be using an appropriate method of contraception&#xD;
             according to the definition of Note of ICH M3 Guideline (implants, injectables,&#xD;
             combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner),&#xD;
             and (3) be willing to continue using the contraceptive method throughout the entire&#xD;
             study period.&#xD;
&#xD;
          5. Subjects must (1) be able to comprehend the full nature and purpose of the study,&#xD;
             including possible risks and side effects, (2) fully co-operate with the Investigator,&#xD;
             (3) comply with the requirements of the entire study.&#xD;
&#xD;
          6. Patients undergoing surgical extraction of a single, fully or partially impacted&#xD;
             mandibular 3rd molar requiring bone removal.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        General&#xD;
&#xD;
          1. Patients refusing to give written informed consent.&#xD;
&#xD;
          2. Patients not able to understand the purposes of the study or not willing to return for&#xD;
             the control visits.&#xD;
&#xD;
          3. Patients with major psychiatric disorders that, in the investigator's opinion, could&#xD;
             compromise study participation.&#xD;
&#xD;
          4. Patients enrolled in any clinical trial in the previous 3 months.&#xD;
&#xD;
          5. Employees of the study centre with direct involvement in the proposed study or other&#xD;
             studies under the direction of the main investigator or study centre, as well as&#xD;
             family members of the employees or investigator.&#xD;
&#xD;
          6. Pregnant or breast-feeding women.&#xD;
&#xD;
          7. Alcohol or drug abuse in the previous 12 months.&#xD;
&#xD;
          8. Clinically significant or unstable concomitant disease whose sequelae might interfere&#xD;
             with the study evaluation parameters.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Thomas Dietrich, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The School of Dentistry, University of Birmingham</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The School of Dentistry University of Birmingham</name>
      <address>
        <city>Birmingham</city>
        <zip>B4 6NN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>October 1, 2012</study_first_submitted>
  <study_first_submitted_qc>October 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2012</study_first_posted>
  <results_first_submitted>August 13, 2014</results_first_submitted>
  <results_first_submitted_qc>August 27, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">August 28, 2014</results_first_posted>
  <last_update_submitted>August 28, 2014</last_update_submitted>
  <last_update_submitted_qc>August 28, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 5, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>diclofenac, postsurgical pain, oral surgery</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diclofenac</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Diclofenac Sodium 5 mg/mL</title>
          <description>Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.</description>
        </group>
        <group group_id="P2">
          <title>Diclofenac Sodium 12.5 mg/mL</title>
          <description>Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.</description>
        </group>
        <group group_id="P3">
          <title>Diclofenac Sodium 25 mg/mL</title>
          <description>Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.</description>
        </group>
        <group group_id="P4">
          <title>Diclofenac Sodium 50 mg/mL</title>
          <description>Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.</description>
        </group>
        <group group_id="P5">
          <title>Placebo 1 mL</title>
          <description>One single placebo injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="15"/>
                <participants group_id="P3" count="15"/>
                <participants group_id="P4" count="14"/>
                <participants group_id="P5" count="16"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="15"/>
                <participants group_id="P3" count="15"/>
                <participants group_id="P4" count="14"/>
                <participants group_id="P5" count="16"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Diclofenac Sodium 5 mg/mL</title>
          <description>Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.</description>
        </group>
        <group group_id="B2">
          <title>Diclofenac Sodium 12.5 mg/mL</title>
          <description>Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.</description>
        </group>
        <group group_id="B3">
          <title>Diclofenac Sodium 25 mg/mL</title>
          <description>Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.</description>
        </group>
        <group group_id="B4">
          <title>Diclofenac Sodium 50 mg/mL</title>
          <description>Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.</description>
        </group>
        <group group_id="B5">
          <title>Placebo 1 mL</title>
          <description>One single placebo injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.</description>
        </group>
        <group group_id="B6">
          <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="15"/>
            <count group_id="B2" value="15"/>
            <count group_id="B3" value="15"/>
            <count group_id="B4" value="14"/>
            <count group_id="B5" value="16"/>
            <count group_id="B6" value="75"/>
          </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="28" spread="7.3"/>
                    <measurement group_id="B2" value="28" spread="9.4"/>
                    <measurement group_id="B3" value="30" spread="9"/>
                    <measurement group_id="B4" value="27" spread="4.5"/>
                    <measurement group_id="B5" value="30" spread="9.5"/>
                    <measurement group_id="B6" value="28.6" spread="7.94"/>
                  </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="9"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="12"/>
                    <measurement group_id="B4" value="8"/>
                    <measurement group_id="B5" value="12"/>
                    <measurement group_id="B6" value="47"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="4"/>
                    <measurement group_id="B6" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Area Under the Curve (AUC) of the Pain Scores.</title>
        <description>Pain will be scored by the patient at the end of surgery (time 0) and at 15-minute intervals after surgery for a total of 6 hours on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable).</description>
        <time_frame>Pain scores will be measured over the time from end of surgery (time 0) to the 6 hour post-surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Diclofenac Sodium 5 mg/mL</title>
            <description>Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.</description>
          </group>
          <group group_id="O2">
            <title>Diclofenac Sodium 12.5 mg/mL</title>
            <description>Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.</description>
          </group>
          <group group_id="O3">
            <title>Diclofenac Sodium 25 mg/mL</title>
            <description>Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.</description>
          </group>
          <group group_id="O4">
            <title>Diclofenac Sodium 50 mg/mL</title>
            <description>Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.</description>
          </group>
          <group group_id="O5">
            <title>Placebo 1 mL</title>
            <description>One single placebo injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Curve (AUC) of the Pain Scores.</title>
          <description>Pain will be scored by the patient at the end of surgery (time 0) and at 15-minute intervals after surgery for a total of 6 hours on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable).</description>
          <units>mm*minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="14"/>
                <count group_id="O5" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6843" spread="6259"/>
                    <measurement group_id="O2" value="8832" spread="6330"/>
                    <measurement group_id="O3" value="9998" spread="8080"/>
                    <measurement group_id="O4" value="7290" spread="6509"/>
                    <measurement group_id="O5" value="15539" spread="9279"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Postsurgical Extra-oral Swelling</title>
        <time_frame>measured at 6 hours postsurgery, at day 3 and 1 week postsurgery</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Trismus</title>
        <time_frame>measured at 6 hours postsurgery, at day 3 and 1 week postsurgery</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Peak Pain Intensity</title>
        <time_frame>measured from end of surgery up to 12 hours postsurgery</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to First Use of Rescue Medication.</title>
        <time_frame>measured from end of surgery up to 1 week postsurgery</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Amount of Rescue Medication</title>
        <time_frame>consumed by the patient every 15-minutes postsurgery up to 6 hours postsurgery</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Rescue Medication Consumption</title>
        <time_frame>consumed by the patient from end of surgery up to 24 and up to 48 hours postsurgery</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient and Investigator Global Evaluation of the Effectiveness of Treatment</title>
        <time_frame>at 6 hour postsurgery and on Day 3</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Onset of Pain</title>
        <time_frame>measured from end of surgery up to 12 hours postsurgery</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Wound Healing</title>
        <time_frame>at 6 hour postsurgery, and on day 3 and 1 week postsurgery</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Recurrent Bleeding</title>
        <time_frame>every hour up to 6 hour postsurgery</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Vital Signs</title>
        <time_frame>presurgery (within 30 days from surgery), at day of surgery (day 1), day 3 and 1 week postsurgery.</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Patients With Adverse Events</title>
        <time_frame>from signature of the informed consent to 1 week postsurgery</time_frame>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Diclofenac Sodium 5 mg/mL</title>
          <description>Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.</description>
        </group>
        <group group_id="E2">
          <title>Diclofenac Sodium 12.5 mg/mL</title>
          <description>Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.</description>
        </group>
        <group group_id="E3">
          <title>Diclofenac Sodium 25 mg/mL</title>
          <description>Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.</description>
        </group>
        <group group_id="E4">
          <title>Diclofenac Sodium 50 mg/mL</title>
          <description>Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.</description>
        </group>
        <group group_id="E5">
          <title>Placebo 1 mL</title>
          <description>One single placebo injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.</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="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="14"/>
                <counts group_id="E5" subjects_affected="6" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>linphadenopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>ear pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>vomiting</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>nausea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>gingival ulceration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>diarrhoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>injection site pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E3" events="5" subjects_affected="4" subjects_at_risk="15"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>swelling</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>injection site swelling</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>wound infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>procedural pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>pain in jaw</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>joint stiffness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>headache</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E5" events="4" subjects_affected="2" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>dizziness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>lethargy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>somnolence</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>oropharyngeal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>hot flush</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="16"/>
              </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>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Prof. Thomas Dietrich</name_or_title>
      <organization>The School of Dentistry, University of Birmingham</organization>
      <phone>+44-121-46 65494</phone>
      <email>t.dietrich@bham.ac.uk</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/NCT01706588
org study id: 12UK/DCsc04
nct id: NCT01706588
lead sponsor: 
has dmc: No
This is a prospective, randomised, double-blind, placebo-controlled, parallel group study in
      approximately 75 patients undergoing surgical removal of an impacted lower third molar.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Area Under the Curve (AUC) of the Pain Scores.
time frame: Pain scores will be measured over the time from end of surgery (time 0) to the 6 hour post-surgery
description: Pain will be scored by the patient at the end of surgery (time 0) and at 15-minute intervals after surgery for a total of 6 hours on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable).
measure: Postsurgical Extra-oral Swelling
time frame: measured at 6 hours postsurgery, at day 3 and 1 week postsurgery
measure: Trismus
time frame: measured at 6 hours postsurgery, at day 3 and 1 week postsurgery
measure: Peak Pain Intensity
time frame: measured from end of surgery up to 12 hours postsurgery
measure: Time to First Use of Rescue Medication.
time frame: measured from end of surgery up to 1 week postsurgery
measure: Amount of Rescue Medication
time frame: consumed by the patient every 15-minutes postsurgery up to 6 hours postsurgery
measure: Rescue Medication Consumption
time frame: consumed by the patient from end of surgery up to 24 and up to 48 hours postsurgery
measure: Patient and Investigator Global Evaluation of the Effectiveness of Treatment
time frame: at 6 hour postsurgery and on Day 3
measure: Time to Onset of Pain
time frame: measured from end of surgery up to 12 hours postsurgery
measure: Wound Healing
time frame: at 6 hour postsurgery, and on day 3 and 1 week postsurgery
measure: Recurrent Bleeding
time frame: every hour up to 6 hour postsurgery
measure: Vital Signs
time frame: presurgery (within 30 days from surgery), at day of surgery (day 1), day 3 and 1 week postsurgery.
measure: Number of Patients With Adverse Events
time frame: from signature of the informed consent to 1 week postsurgery
arm group label: Diclofenac sodium 5 mg/mL
arm group type: Experimental
arm group label: Diclofenac sodium 12.5 mg/mL
arm group type: Experimental
arm group label: Diclofenac sodium 25 mg/mL
arm group type: Experimental
arm group label: Diclofenac sodium 50 mg/mL
arm group type: Experimental
arm group label: Placebo 1 mL
arm group type: Placebo Comparator
intervention type: Drug
intervention name: Diclofenac sodium
description: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
arm group label: Diclofenac sodium 12.5 mg/mL
arm group label: Diclofenac sodium 25 mg/mL
arm group label: Diclofenac sodium 5 mg/mL
arm group label: Diclofenac sodium 50 mg/mL
arm group label: Placebo 1 mL
other name: Diclofenac HPBCD
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Thomas Dietrich, MD
role: Principal Investigator
affiliation: The School of Dentistry, University of Birmingham
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Diclofenac
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 