<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/NCT02246166</url>
  </required_header>
  <id_info>
    <org_study_id>202271</org_study_id>
    <secondary_id>RH02565</secondary_id>
    <nct_id>NCT02246166</nct_id>
  </id_info>
  <brief_title>The Effect of Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets Compared to Placebo in Subjects Suffering From the Common Cold or Influenza.</brief_title>
  <official_title>A Double-Blind, Randomised, Placebo-Controlled, Parallelgroup, Single-Dose Study to Evaluate Effect of Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets Compared to Placebo in Subjects Suffering From the Common Cold or Influenza Over a 4 Hour Period</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GlaxoSmithKline</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Sino-American Tianjin Smith Kline &amp; French Laboratories Ltd</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>GlaxoSmithKline</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This phase IV multi-centre, randomised, double-blind, placebo-controlled, parallel-group,&#xD;
      single-dose study will assess the efficacy and tolerability of the active tablets versus&#xD;
      placebo in participants suffering from cold and influenza. Eligible participants will be&#xD;
      randomly assigned to one of 2 treatment groups (active or placebo tablets) and enter a&#xD;
      four-hour (hr) treatment phase. Each participant will be administered only once during each&#xD;
      study period. Participants will use a questionnaire to record the symptom severity scores as&#xD;
      described, as well as time.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2015</start_date>
  <completion_date type="Actual">February 2015</completion_date>
  <primary_completion_date type="Actual">February 2015</primary_completion_date>
  <phase>Phase 4</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>Symptom Severity Assessment at 15 Minutes</measure>
    <time_frame>15 minutes</time_frame>
    <description>Symptom severity assessment was determined by Total Sum Score (TSS), TSS ranged from 0 to 21 with less severity score at the given time point represented a better outcome measure.&#xD;
TSS was calculated as the sum of the non missing scores (all on a 0-3 scale measuring worsening or severity) of the following common cold symptoms: sore throat, headache, extremities pain, nasal congestion, runny nose, sneezing, and cough post treatment administration.&#xD;
Participants self assessed symptoms severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at 15 minutes post product use.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Symptom Severity Assessment at 30 Minutes</measure>
    <time_frame>30 minutes</time_frame>
    <description>Symptom severity assessment was determined by TSS, TSS ranged from 0 to 21 with less severity score at the given time point represented a better outcome measure.&#xD;
TSS was calculated as the sum of the non missing scores (all on a 0-3 scale measuring worsening or severity) of the following common cold symptoms: sore throat, headache, extremities pain, nasal congestion, runny nose, sneezing, and cough post treatment administration.&#xD;
Participants self assessed symptoms severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at 30 minutes post product use.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Symptom Severity Assessment at 1 Hour</measure>
    <time_frame>1 hour</time_frame>
    <description>Symptom severity assessment was determined by TSS, TSS ranged from 0 to 21 with less severity score at the given time point represented a better outcome measure.&#xD;
TSS was calculated as the sum of the non missing scores (all on a 0-3 scale measuring worsening or severity) of the following common cold symptoms: sore throat, headache, extremities pain, nasal congestion, runny nose, sneezing, and cough post treatment administration.&#xD;
Participants self assessed symptoms severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at 1hour post product use.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Symptom Severity Assessment at 2 Hours</measure>
    <time_frame>2 hours</time_frame>
    <description>Symptom severity assessment was determined by TSS, TSS ranged from 0 to 21 with less severity score at the given time point represented a better outcome measure.&#xD;
TSS was calculated as the sum of the non missing scores (all on a 0-3 scale measuring worsening or severity) of the following common cold symptoms: sore throat, headache, extremities pain, nasal congestion, runny nose, sneezing, and cough post treatment administration.&#xD;
Participants self assessed symptoms severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at 2 hours post product use.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Symptom Severity Assessment at 3 Hours</measure>
    <time_frame>3 hours</time_frame>
    <description>Symptom severity assessment was determined by TSS, TSS ranged from 0 to 21 with less severity score at the given time point represented a better outcome measure.&#xD;
TSS was calculated as the sum of the non missing scores (all on a 0-3 scale measuring worsening or severity) of the following common cold symptoms: sore throat, headache, extremities pain, nasal congestion, runny nose, sneezing, and cough post treatment administration.&#xD;
Participants self assessed symptoms severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at 3 hours post product use.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Symptom Severity Assessment at 4 Hours</measure>
    <time_frame>4 hours</time_frame>
    <description>Symptom severity assessment was determined by TSS, TSS ranged from 0 to 21 with less severity score at the given time point represented a better outcome measure.&#xD;
TSS was calculated as the sum of the non missing scores (all on a 0-3 scale measuring worsening or severity) of the following common cold symptoms: sore throat, headache, extremities pain, nasal congestion, runny nose, sneezing, and cough post treatment administration.&#xD;
Participants self assessed symptoms severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at 4 hours post product use.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Global Assessment of Treatment</measure>
    <time_frame>4 hours</time_frame>
    <description>After completing the 4 hours symptom severity assessments, participants evaluated their treatment response on a 5-point scale by answering the question: &quot;How well did the test medication control your symptoms?&quot; (0-ineffective, 1-poor, 2-fair, 3-good, or 4-excellent).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sore Throat Severity Assessment</measure>
    <time_frame>Change from baseline in 15, 30, 60,120, 180, and 240 minutes</time_frame>
    <description>Participants self-assessed sore throat severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 15, 30, 60, 120,180 and 240 minutes post product administration. All sore throat severity assessment values were recorded in questionnaire and tabulated. A reduction in severity score from baseline represented a better outcome measure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Headache Severity Assessment</measure>
    <time_frame>Change from baseline in 15, 30, 60,120, 180, and 240 minutes</time_frame>
    <description>Participants self-assessed headache severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 15, 30, 60, 120,180 and 240 minutes post product administration. All headache severity assessment values were recorded in questionnaire and tabulated. A reduction in severity score from baseline represented a better outcome measure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Extremities Pain Severity Assessment</measure>
    <time_frame>Change from baseline in 15, 30, 60,120, 180, and 240 minutes</time_frame>
    <description>Participants self-assessed extremities pain severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 15, 30, 60, 120,180 and 240 minutes post product administration. All extremities pain severity assessment values were recorded in a questionnaire and tabulated. A reduction in severity score from baseline represented a better outcome measure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nasal Congestion Severity Assessment</measure>
    <time_frame>Change from baseline in 15, 30, 60,120, 180, and 240 minutes</time_frame>
    <description>Participants self-assessed nasal congestion severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 15, 30, 60, 120,180 and 240 minutes post product administration. All nasal congestion severity assessment values were recorded in a questionnaire and tabulated. A reduction in severity score from baseline represented a better outcome measure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Runny Nose Severity Assessment</measure>
    <time_frame>Change from baseline in 15, 30, 60,120, 180, and 240 minutes</time_frame>
    <description>Participants self-assessed runny nose severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 15, 30, 60, 120,180 and 240 minutes post product administration. All runny nose severity assessment values were recorded in questionnaire and tabulated. A reduction in severity score from baseline represented a better outcome measure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sneezing Severity Assessment</measure>
    <time_frame>Change from baseline in 15, 30, 60,120, 180, and 240 minutes</time_frame>
    <description>Participants self-assessed sneezing severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 15, 30, 60, 120,180 and 240 minutes post product administration. All sneezing severity assessment values were recorded in a questionnaire and tabulated. A reduction in severity score from baseline represented a better outcome measure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cough Severity Assessment</measure>
    <time_frame>Change from baseline in 15, 30, 60,120, 180, and 240 minutes</time_frame>
    <description>Participants self-assessed cough severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 15, 30, 60, 120,180 and 240 minutes post product administration. All cough severity assessment values were recorded in a questionnaire and tabulated. A reduction in severity score from baseline represented a better outcome measure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body Temperature Reduction</measure>
    <time_frame>Change from baseline in 15, 30, 60,120, 180, and 240 minutes</time_frame>
    <description>Summary statistics for body temperature was presented at baseline and at 15, 30, 60, 120,180 and 240 minutes post treatment. Wilcoxon Rank Sum test was used to investigate if there are any significant treatment differences.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">53</enrollment>
  <condition>Common Cold</condition>
  <arm_group>
    <arm_group_label>Test tablet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Matching placebo tablet</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Test tablet</intervention_name>
    <description>The active tablet will be administered orally. Product administration will occur within 30mins of the baseline assessment of symptom severity</description>
    <arm_group_label>Test tablet</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>The placebo tablet will be administered orally. Product administration will occur within 30mins of the baseline assessment of symptom severity</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged at least 18 years and less than 65 years&#xD;
&#xD;
          -  Good general and mental health in the opinion of the investigator&#xD;
&#xD;
          -  Participants diagnosed with a common cold or flu and must have the following symptoms&#xD;
             of at least &quot;moderate&quot; in intensity (≥ 2) at the screening visit (baseline), with a&#xD;
             minimum total symptom score of 6:&#xD;
&#xD;
             (i) At least one of pain symptoms: sore throat, headache, or extremities pain (ii)&#xD;
             Mandatory: Nasal congestion (iii) At least one of catarrh symptoms: runny nose or&#xD;
             sneezing&#xD;
&#xD;
          -  Onset of first symptoms of cold must have occurred within 48 hours of screening.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or breast feeding women&#xD;
&#xD;
          -  History of seasonal or perennial allergic rhinitis or acute, sub-chronic, or chronic&#xD;
             cough due to any condition other than a common cold or flu, as determined by the&#xD;
             investigator&#xD;
&#xD;
          -  Concurrent illness or medical history that is contraindicated or cautioned about in&#xD;
             the drug label&#xD;
&#xD;
          -  Anatomical factors causing nasal congestion&#xD;
&#xD;
          -  Fever with body temperature &gt;38.5°C at baseline&#xD;
&#xD;
          -  Have used any medication or herbal remedies to treat cold prior to screening&#xD;
             (antibiotics in the last 7 days, antihistamines in the last 72 hours, analgesics or&#xD;
             antipyretics in the last 24 hours, decongestant in the last 12 hours, antitussive,&#xD;
             medicated lozenge or throat spray in the last 8 hours)&#xD;
&#xD;
          -  Any medication that has potential drug-drug interactions with study medications&#xD;
&#xD;
          -  Known or suspected intolerance or hypersensitivity to the study materials&#xD;
&#xD;
          -  Have a positive drug urine test or recent history (within the last 2 years) of alcohol&#xD;
             or other substance abuse&#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>GSK Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>GlaxoSmithKline</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Shanghai</city>
        <zip>200025</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Shanghai</city>
        <zip>200120</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>May 2016</verification_date>
  <study_first_submitted>September 18, 2014</study_first_submitted>
  <study_first_submitted_qc>September 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 22, 2014</study_first_posted>
  <results_first_submitted>October 8, 2015</results_first_submitted>
  <results_first_submitted_qc>May 12, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">June 21, 2016</results_first_posted>
  <last_update_submitted>August 2, 2016</last_update_submitted>
  <last_update_submitted_qc>August 2, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 14, 2016</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>Common Cold</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The participants were recruited at 2 clinical sites in China</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Test Tablet</title>
          <description>Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>Matching placebo tablet</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="26"/>
                <participants group_id="P2" count="27"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
                <participants group_id="P2" count="27"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Overall participants in the test arm were 25 as 1 participant data was not included in the baseline measure as he did not completed the study (Due to protocol deviation).</population>
      <group_list>
        <group group_id="B1">
          <title>Test Tablet</title>
          <description>Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>Matching placebo tablet</description>
        </group>
        <group group_id="B3">
          <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="25"/>
            <count group_id="B2" value="27"/>
            <count group_id="B3" value="52"/>
          </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="37.8" spread="11.97"/>
                    <measurement group_id="B2" value="38.5" spread="11.06"/>
                    <measurement group_id="B3" value="38.2" spread="11.40"/>
                  </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="21"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="40"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Symptom Severity Assessment at 15 Minutes</title>
        <description>Symptom severity assessment was determined by Total Sum Score (TSS), TSS ranged from 0 to 21 with less severity score at the given time point represented a better outcome measure.&#xD;
TSS was calculated as the sum of the non missing scores (all on a 0-3 scale measuring worsening or severity) of the following common cold symptoms: sore throat, headache, extremities pain, nasal congestion, runny nose, sneezing, and cough post treatment administration.&#xD;
Participants self assessed symptoms severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at 15 minutes post product use.</description>
        <time_frame>15 minutes</time_frame>
        <population>The primary population for assessment of efficacy was the intent to treat (ITT) population. The ITT population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.</population>
        <group_list>
          <group group_id="O1">
            <title>Test Tablet</title>
            <description>Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Matching placebo tablet</description>
          </group>
        </group_list>
        <measure>
          <title>Symptom Severity Assessment at 15 Minutes</title>
          <description>Symptom severity assessment was determined by Total Sum Score (TSS), TSS ranged from 0 to 21 with less severity score at the given time point represented a better outcome measure.&#xD;
TSS was calculated as the sum of the non missing scores (all on a 0-3 scale measuring worsening or severity) of the following common cold symptoms: sore throat, headache, extremities pain, nasal congestion, runny nose, sneezing, and cough post treatment administration.&#xD;
Participants self assessed symptoms severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at 15 minutes post product use.</description>
          <population>The primary population for assessment of efficacy was the intent to treat (ITT) population. The ITT population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.</population>
          <units>Score on scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Observed value</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.66" spread="0.309"/>
                    <measurement group_id="O2" value="10.64" spread="0.304"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.11" spread="0.309"/>
                    <measurement group_id="O2" value="-1.13" spread="0.304"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.9473</p_value>
            <method>ANCOVA</method>
            <method_desc>From ANCOVA model with factors for treatment group and study site and baseline TSS score as a covariate</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.03</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.77</ci_lower_limit>
            <ci_upper_limit>0.83</ci_upper_limit>
            <estimate_desc>Difference is first named treatment minus the second named treatment such that a negative difference favors the first named treatment</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Symptom Severity Assessment at 30 Minutes</title>
        <description>Symptom severity assessment was determined by TSS, TSS ranged from 0 to 21 with less severity score at the given time point represented a better outcome measure.&#xD;
TSS was calculated as the sum of the non missing scores (all on a 0-3 scale measuring worsening or severity) of the following common cold symptoms: sore throat, headache, extremities pain, nasal congestion, runny nose, sneezing, and cough post treatment administration.&#xD;
Participants self assessed symptoms severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at 30 minutes post product use.</description>
        <time_frame>30 minutes</time_frame>
        <population>The primary population for assessment of efficacy was the intent to treat (ITT) population. The intent-to-treat (ITT) population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.</population>
        <group_list>
          <group group_id="O1">
            <title>Test Tablet</title>
            <description>Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Matching placebo tablet</description>
          </group>
        </group_list>
        <measure>
          <title>Symptom Severity Assessment at 30 Minutes</title>
          <description>Symptom severity assessment was determined by TSS, TSS ranged from 0 to 21 with less severity score at the given time point represented a better outcome measure.&#xD;
TSS was calculated as the sum of the non missing scores (all on a 0-3 scale measuring worsening or severity) of the following common cold symptoms: sore throat, headache, extremities pain, nasal congestion, runny nose, sneezing, and cough post treatment administration.&#xD;
Participants self assessed symptoms severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at 30 minutes post product use.</description>
          <population>The primary population for assessment of efficacy was the intent to treat (ITT) population. The intent-to-treat (ITT) population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.</population>
          <units>Score on scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Observed value</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.55" spread="0.402"/>
                    <measurement group_id="O2" value="9.74" spread="0.396"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.22" spread="0.402"/>
                    <measurement group_id="O2" value="-2.03" spread="0.396"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.7210</p_value>
            <method>ANCOVA</method>
            <method_desc>From ANCOVA model with factors for treatment group and study site and baseline TSS score as a covariate.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.19</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.23</ci_lower_limit>
            <ci_upper_limit>0.86</ci_upper_limit>
            <estimate_desc>Difference is first named treatment minus the second named treatment such that a negative difference favors the first named treatme</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Symptom Severity Assessment at 1 Hour</title>
        <description>Symptom severity assessment was determined by TSS, TSS ranged from 0 to 21 with less severity score at the given time point represented a better outcome measure.&#xD;
TSS was calculated as the sum of the non missing scores (all on a 0-3 scale measuring worsening or severity) of the following common cold symptoms: sore throat, headache, extremities pain, nasal congestion, runny nose, sneezing, and cough post treatment administration.&#xD;
Participants self assessed symptoms severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at 1hour post product use.</description>
        <time_frame>1 hour</time_frame>
        <population>The primary population for assessment of efficacy was the intent to treat (ITT) population. The intent-to-treat (ITT) population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.</population>
        <group_list>
          <group group_id="O1">
            <title>Test Tablet</title>
            <description>Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Matching placebo tablet</description>
          </group>
        </group_list>
        <measure>
          <title>Symptom Severity Assessment at 1 Hour</title>
          <description>Symptom severity assessment was determined by TSS, TSS ranged from 0 to 21 with less severity score at the given time point represented a better outcome measure.&#xD;
TSS was calculated as the sum of the non missing scores (all on a 0-3 scale measuring worsening or severity) of the following common cold symptoms: sore throat, headache, extremities pain, nasal congestion, runny nose, sneezing, and cough post treatment administration.&#xD;
Participants self assessed symptoms severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at 1hour post product use.</description>
          <population>The primary population for assessment of efficacy was the intent to treat (ITT) population. The intent-to-treat (ITT) population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.</population>
          <units>Score on scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Observed value</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.73" spread="0.495"/>
                    <measurement group_id="O2" value="8.52" spread="0.487"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.04" spread="0.495"/>
                    <measurement group_id="O2" value="-3.25" spread="0.487"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.7445</p_value>
            <method>ANCOVA</method>
            <method_desc>From ANCOVA model with factors for treatment group and study site and baseline TSS score as a covariate.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.21</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.07</ci_lower_limit>
            <ci_upper_limit>1.49</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Symptom Severity Assessment at 2 Hours</title>
        <description>Symptom severity assessment was determined by TSS, TSS ranged from 0 to 21 with less severity score at the given time point represented a better outcome measure.&#xD;
TSS was calculated as the sum of the non missing scores (all on a 0-3 scale measuring worsening or severity) of the following common cold symptoms: sore throat, headache, extremities pain, nasal congestion, runny nose, sneezing, and cough post treatment administration.&#xD;
Participants self assessed symptoms severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at 2 hours post product use.</description>
        <time_frame>2 hours</time_frame>
        <population>The primary population for assessment of efficacy was the intent to treat (ITT) population. The ITT population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.</population>
        <group_list>
          <group group_id="O1">
            <title>Test Tablet</title>
            <description>Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Matching placebo tablet</description>
          </group>
        </group_list>
        <measure>
          <title>Symptom Severity Assessment at 2 Hours</title>
          <description>Symptom severity assessment was determined by TSS, TSS ranged from 0 to 21 with less severity score at the given time point represented a better outcome measure.&#xD;
TSS was calculated as the sum of the non missing scores (all on a 0-3 scale measuring worsening or severity) of the following common cold symptoms: sore throat, headache, extremities pain, nasal congestion, runny nose, sneezing, and cough post treatment administration.&#xD;
Participants self assessed symptoms severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at 2 hours post product use.</description>
          <population>The primary population for assessment of efficacy was the intent to treat (ITT) population. The ITT population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.</population>
          <units>Score on scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Observed value</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.54" spread="0.596"/>
                    <measurement group_id="O2" value="7.31" spread="0.587"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.23" spread="0.596"/>
                    <measurement group_id="O2" value="-4.46" spread="0.587"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.7662</p_value>
            <method>ANCOVA</method>
            <method_desc>From ANCOVA model with factors for treatment group and study site and baseline TSS score as a covariate</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.23</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.32</ci_lower_limit>
            <ci_upper_limit>1.78</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Symptom Severity Assessment at 3 Hours</title>
        <description>Symptom severity assessment was determined by TSS, TSS ranged from 0 to 21 with less severity score at the given time point represented a better outcome measure.&#xD;
TSS was calculated as the sum of the non missing scores (all on a 0-3 scale measuring worsening or severity) of the following common cold symptoms: sore throat, headache, extremities pain, nasal congestion, runny nose, sneezing, and cough post treatment administration.&#xD;
Participants self assessed symptoms severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at 3 hours post product use.</description>
        <time_frame>3 hours</time_frame>
        <population>The primary population for assessment of efficacy was the intent to treat (ITT) population. The ITT population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.</population>
        <group_list>
          <group group_id="O1">
            <title>Test Tablet</title>
            <description>Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Matching placebo tablet</description>
          </group>
        </group_list>
        <measure>
          <title>Symptom Severity Assessment at 3 Hours</title>
          <description>Symptom severity assessment was determined by TSS, TSS ranged from 0 to 21 with less severity score at the given time point represented a better outcome measure.&#xD;
TSS was calculated as the sum of the non missing scores (all on a 0-3 scale measuring worsening or severity) of the following common cold symptoms: sore throat, headache, extremities pain, nasal congestion, runny nose, sneezing, and cough post treatment administration.&#xD;
Participants self assessed symptoms severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at 3 hours post product use.</description>
          <population>The primary population for assessment of efficacy was the intent to treat (ITT) population. The ITT population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.</population>
          <units>Score on scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Observed value</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.80" spread="0.669"/>
                    <measurement group_id="O2" value="6.25" spread="0.659"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.97" spread="0.669"/>
                    <measurement group_id="O2" value="-5.52" spread="0.659"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.5208</p_value>
            <method>ANCOVA</method>
            <method_desc>From ANCOVA model with factors for treatment group and study site and baseline TSS score as a covariate.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.56</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.18</ci_lower_limit>
            <ci_upper_limit>2.29</ci_upper_limit>
            <estimate_desc>Difference is first named treatment minus the second named treatment such that a negative difference favors the first named treatment</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Symptom Severity Assessment at 4 Hours</title>
        <description>Symptom severity assessment was determined by TSS, TSS ranged from 0 to 21 with less severity score at the given time point represented a better outcome measure.&#xD;
TSS was calculated as the sum of the non missing scores (all on a 0-3 scale measuring worsening or severity) of the following common cold symptoms: sore throat, headache, extremities pain, nasal congestion, runny nose, sneezing, and cough post treatment administration.&#xD;
Participants self assessed symptoms severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at 4 hours post product use.</description>
        <time_frame>4 hours</time_frame>
        <population>The primary population for assessment of efficacy was the intent to treat (ITT) population. The ITT population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.</population>
        <group_list>
          <group group_id="O1">
            <title>Test Tablet</title>
            <description>Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Matching placebo tablet</description>
          </group>
        </group_list>
        <measure>
          <title>Symptom Severity Assessment at 4 Hours</title>
          <description>Symptom severity assessment was determined by TSS, TSS ranged from 0 to 21 with less severity score at the given time point represented a better outcome measure.&#xD;
TSS was calculated as the sum of the non missing scores (all on a 0-3 scale measuring worsening or severity) of the following common cold symptoms: sore throat, headache, extremities pain, nasal congestion, runny nose, sneezing, and cough post treatment administration.&#xD;
Participants self assessed symptoms severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at 4 hours post product use.</description>
          <population>The primary population for assessment of efficacy was the intent to treat (ITT) population. The ITT population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.</population>
          <units>Score on scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Observed value</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.94" spread="0.702"/>
                    <measurement group_id="O2" value="5.82" spread="0.692"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.83" spread="0.702"/>
                    <measurement group_id="O2" value="-5.95" spread="0.692"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.8993</p_value>
            <method>ANCOVA</method>
            <method_desc>From ANCOVA model with factors for treatment group and study site and baseline TSS score as a covariate.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.12</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.71</ci_lower_limit>
            <ci_upper_limit>1.94</ci_upper_limit>
            <estimate_desc>Difference is first named treatment minus the second named treatment such that a negative difference favors the first named treatment</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Global Assessment of Treatment</title>
        <description>After completing the 4 hours symptom severity assessments, participants evaluated their treatment response on a 5-point scale by answering the question: &quot;How well did the test medication control your symptoms?&quot; (0-ineffective, 1-poor, 2-fair, 3-good, or 4-excellent).</description>
        <time_frame>4 hours</time_frame>
        <population>The primary population for assessment of efficacy was the intent to treat (ITT) population. The ITT population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.</population>
        <group_list>
          <group group_id="O1">
            <title>Test Tablet</title>
            <description>Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Matching placebo tablet</description>
          </group>
        </group_list>
        <measure>
          <title>Global Assessment of Treatment</title>
          <description>After completing the 4 hours symptom severity assessments, participants evaluated their treatment response on a 5-point scale by answering the question: &quot;How well did the test medication control your symptoms?&quot; (0-ineffective, 1-poor, 2-fair, 3-good, or 4-excellent).</description>
          <population>The primary population for assessment of efficacy was the intent to treat (ITT) population. The ITT population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Ineffective (0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Poor (1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fair (2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Good (3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Excellent (4)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Sore Throat Severity Assessment</title>
        <description>Participants self-assessed sore throat severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 15, 30, 60, 120,180 and 240 minutes post product administration. All sore throat severity assessment values were recorded in questionnaire and tabulated. A reduction in severity score from baseline represented a better outcome measure.</description>
        <time_frame>Change from baseline in 15, 30, 60,120, 180, and 240 minutes</time_frame>
        <population>The primary population for assessment of efficacy was the intent to treat (ITT) population. The ITT population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.</population>
        <group_list>
          <group group_id="O1">
            <title>Test Tablet</title>
            <description>Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Matching placebo tablet</description>
          </group>
        </group_list>
        <measure>
          <title>Sore Throat Severity Assessment</title>
          <description>Participants self-assessed sore throat severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 15, 30, 60, 120,180 and 240 minutes post product administration. All sore throat severity assessment values were recorded in questionnaire and tabulated. A reduction in severity score from baseline represented a better outcome measure.</description>
          <population>The primary population for assessment of efficacy was the intent to treat (ITT) population. The ITT population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.</population>
          <units>Score on scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change from baseline in 15 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.12" spread="0.076"/>
                    <measurement group_id="O2" value="-0.28" spread="0.073"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from baseline in 30 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.21" spread="0.082"/>
                    <measurement group_id="O2" value="-0.29" spread="0.080"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from baseline in 60 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.27" spread="0.099"/>
                    <measurement group_id="O2" value="-0.29" spread="0.096"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from baseline in 120 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.33" spread="0.124"/>
                    <measurement group_id="O2" value="-0.49" spread="0.120"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from baseline in 180 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.33" spread="0.132"/>
                    <measurement group_id="O2" value="-0.53" spread="0.128"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from baseline in 240 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.46" spread="0.137"/>
                    <measurement group_id="O2" value="-0.71" spread="0.133"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Headache Severity Assessment</title>
        <description>Participants self-assessed headache severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 15, 30, 60, 120,180 and 240 minutes post product administration. All headache severity assessment values were recorded in questionnaire and tabulated. A reduction in severity score from baseline represented a better outcome measure.</description>
        <time_frame>Change from baseline in 15, 30, 60,120, 180, and 240 minutes</time_frame>
        <population>The primary population for assessment of efficacy was the intent to treat (ITT) population. The ITT population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.</population>
        <group_list>
          <group group_id="O1">
            <title>Test Tablet</title>
            <description>Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Matching placebo tablet</description>
          </group>
        </group_list>
        <measure>
          <title>Headache Severity Assessment</title>
          <description>Participants self-assessed headache severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 15, 30, 60, 120,180 and 240 minutes post product administration. All headache severity assessment values were recorded in questionnaire and tabulated. A reduction in severity score from baseline represented a better outcome measure.</description>
          <population>The primary population for assessment of efficacy was the intent to treat (ITT) population. The ITT population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.</population>
          <units>Score on scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change from baseline in 15 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.17" spread="0.094"/>
                    <measurement group_id="O2" value="-0.14" spread="0.090"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from baseline in 30 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.31" spread="0.113"/>
                    <measurement group_id="O2" value="-0.16" spread="0.108"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from baseline in 60 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.47" spread="0.130"/>
                    <measurement group_id="O2" value="-0.51" spread="0.123"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from baseline in 120 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.72" spread="0.123"/>
                    <measurement group_id="O2" value="-0.71" spread="0.117"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from baseline in 180 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.89" spread="0.130"/>
                    <measurement group_id="O2" value="-0.88" spread="0.123"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from baseline in 240 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.99" spread="0.125"/>
                    <measurement group_id="O2" value="-0.96" spread="0.118"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Extremities Pain Severity Assessment</title>
        <description>Participants self-assessed extremities pain severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 15, 30, 60, 120,180 and 240 minutes post product administration. All extremities pain severity assessment values were recorded in a questionnaire and tabulated. A reduction in severity score from baseline represented a better outcome measure.</description>
        <time_frame>Change from baseline in 15, 30, 60,120, 180, and 240 minutes</time_frame>
        <population>The primary population for assessment of efficacy was the intent to treat (ITT) population. The ITT population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.</population>
        <group_list>
          <group group_id="O1">
            <title>Test Tablet</title>
            <description>Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Matching placebo tablet</description>
          </group>
        </group_list>
        <measure>
          <title>Extremities Pain Severity Assessment</title>
          <description>Participants self-assessed extremities pain severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 15, 30, 60, 120,180 and 240 minutes post product administration. All extremities pain severity assessment values were recorded in a questionnaire and tabulated. A reduction in severity score from baseline represented a better outcome measure.</description>
          <population>The primary population for assessment of efficacy was the intent to treat (ITT) population. The ITT population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.</population>
          <units>Score on scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change from baseline in 15 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.21" spread="0.101"/>
                    <measurement group_id="O2" value="-0.10" spread="0.099"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from baseline in 30 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.22" spread="0.100"/>
                    <measurement group_id="O2" value="-0.19" spread="0.099"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from baseline in 60 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.32" spread="0.104"/>
                    <measurement group_id="O2" value="-0.32" spread="0.102"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from baseline in 120 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.47" spread="0.110"/>
                    <measurement group_id="O2" value="-0.46" spread="0.108"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from baseline in 180 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.58" spread="0.126"/>
                    <measurement group_id="O2" value="-0.57" spread="0.124"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from baseline in 240 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.64" spread="0.126"/>
                    <measurement group_id="O2" value="-0.60" spread="0.124"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Nasal Congestion Severity Assessment</title>
        <description>Participants self-assessed nasal congestion severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 15, 30, 60, 120,180 and 240 minutes post product administration. All nasal congestion severity assessment values were recorded in a questionnaire and tabulated. A reduction in severity score from baseline represented a better outcome measure.</description>
        <time_frame>Change from baseline in 15, 30, 60,120, 180, and 240 minutes</time_frame>
        <population>The primary population for assessment of efficacy was the intent to treat (ITT) population. The ITT population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.</population>
        <group_list>
          <group group_id="O1">
            <title>Test Tablet</title>
            <description>Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Matching placebo tablet</description>
          </group>
        </group_list>
        <measure>
          <title>Nasal Congestion Severity Assessment</title>
          <description>Participants self-assessed nasal congestion severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 15, 30, 60, 120,180 and 240 minutes post product administration. All nasal congestion severity assessment values were recorded in a questionnaire and tabulated. A reduction in severity score from baseline represented a better outcome measure.</description>
          <population>The primary population for assessment of efficacy was the intent to treat (ITT) population. The ITT population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.</population>
          <units>Score on scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change from baseline in 15 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.32" spread="0.086"/>
                    <measurement group_id="O2" value="-0.31" spread="0.084"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from baseline in 30 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.59" spread="0.119"/>
                    <measurement group_id="O2" value="-0.60" spread="0.115"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from baseline in 60 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.61" spread="0.127"/>
                    <measurement group_id="O2" value="-0.68" spread="0.124"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from baseline in 120 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.91" spread="0.138"/>
                    <measurement group_id="O2" value="-1.02" spread="0.134"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from baseline in 180 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.04" spread="0.156"/>
                    <measurement group_id="O2" value="-1.14" spread="0.152"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from baseline in 240 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.19" spread="0.162"/>
                    <measurement group_id="O2" value="-1.20" spread="0.157"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Runny Nose Severity Assessment</title>
        <description>Participants self-assessed runny nose severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 15, 30, 60, 120,180 and 240 minutes post product administration. All runny nose severity assessment values were recorded in questionnaire and tabulated. A reduction in severity score from baseline represented a better outcome measure.</description>
        <time_frame>Change from baseline in 15, 30, 60,120, 180, and 240 minutes</time_frame>
        <population>The primary population for assessment of efficacy was the intent to treat (ITT) population. The ITT population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.</population>
        <group_list>
          <group group_id="O1">
            <title>Test Tablet</title>
            <description>Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Matching placebo tablet</description>
          </group>
        </group_list>
        <measure>
          <title>Runny Nose Severity Assessment</title>
          <description>Participants self-assessed runny nose severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 15, 30, 60, 120,180 and 240 minutes post product administration. All runny nose severity assessment values were recorded in questionnaire and tabulated. A reduction in severity score from baseline represented a better outcome measure.</description>
          <population>The primary population for assessment of efficacy was the intent to treat (ITT) population. The ITT population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.</population>
          <units>Score on scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change from baseline in 15 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.20" spread="0.081"/>
                    <measurement group_id="O2" value="-0.18" spread="0.080"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from baseline in 30 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.48" spread="0.116"/>
                    <measurement group_id="O2" value="-0.32" spread="0.114"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from baseline in 60 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.54" spread="0.145"/>
                    <measurement group_id="O2" value="-0.61" spread="0.143"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from baseline in 120 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.78" spread="0.148"/>
                    <measurement group_id="O2" value="-0.65" spread="0.146"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from baseline in 180 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.89" spread="0.161"/>
                    <measurement group_id="O2" value="-0.98" spread="0.159"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from baseline in 240 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.12" spread="0.149"/>
                    <measurement group_id="O2" value="-0.97" spread="0.147"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Sneezing Severity Assessment</title>
        <description>Participants self-assessed sneezing severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 15, 30, 60, 120,180 and 240 minutes post product administration. All sneezing severity assessment values were recorded in a questionnaire and tabulated. A reduction in severity score from baseline represented a better outcome measure.</description>
        <time_frame>Change from baseline in 15, 30, 60,120, 180, and 240 minutes</time_frame>
        <population>The primary population for assessment of efficacy was the intent to treat (ITT) population. The ITT population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.</population>
        <group_list>
          <group group_id="O1">
            <title>Test Tablet</title>
            <description>Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Matching placebo tablet</description>
          </group>
        </group_list>
        <measure>
          <title>Sneezing Severity Assessment</title>
          <description>Participants self-assessed sneezing severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 15, 30, 60, 120,180 and 240 minutes post product administration. All sneezing severity assessment values were recorded in a questionnaire and tabulated. A reduction in severity score from baseline represented a better outcome measure.</description>
          <population>The primary population for assessment of efficacy was the intent to treat (ITT) population. The ITT population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.</population>
          <units>Score on scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change from baseline in 15 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.10" spread="0.089"/>
                    <measurement group_id="O2" value="-0.24" spread="0.088"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from baseline in 30 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.25" spread="0.103"/>
                    <measurement group_id="O2" value="-0.42" spread="0.102"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from baseline in 60 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.50" spread="0.126"/>
                    <measurement group_id="O2" value="-0.80" spread="0.124"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from baseline in 120 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.67" spread="0.138"/>
                    <measurement group_id="O2" value="-0.86" spread="0.136"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from baseline in 180 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.83" spread="0.138"/>
                    <measurement group_id="O2" value="-1.03" spread="0.136"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from baseline in 240 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.88" spread="0.135"/>
                    <measurement group_id="O2" value="-1.11" spread="0.133"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cough Severity Assessment</title>
        <description>Participants self-assessed cough severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 15, 30, 60, 120,180 and 240 minutes post product administration. All cough severity assessment values were recorded in a questionnaire and tabulated. A reduction in severity score from baseline represented a better outcome measure.</description>
        <time_frame>Change from baseline in 15, 30, 60,120, 180, and 240 minutes</time_frame>
        <population>The primary population for assessment of efficacy was the intent to treat (ITT) population. The ITT population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.</population>
        <group_list>
          <group group_id="O1">
            <title>Test Tablet</title>
            <description>Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Matching placebo tablet</description>
          </group>
        </group_list>
        <measure>
          <title>Cough Severity Assessment</title>
          <description>Participants self-assessed cough severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 15, 30, 60, 120,180 and 240 minutes post product administration. All cough severity assessment values were recorded in a questionnaire and tabulated. A reduction in severity score from baseline represented a better outcome measure.</description>
          <population>The primary population for assessment of efficacy was the intent to treat (ITT) population. The ITT population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.</population>
          <units>Score on scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change from baseline in 15 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.11" spread="0.071"/>
                    <measurement group_id="O2" value="-0.06" spread="0.078"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from baseline in 30 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.28" spread="0.077"/>
                    <measurement group_id="O2" value="-0.25" spread="0.084"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from baseline in 60 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.49" spread="0.116"/>
                    <measurement group_id="O2" value="-0.33" spread="0.126"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from baseline in 120 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.51" spread="0.109"/>
                    <measurement group_id="O2" value="-0.45" spread="0.119"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from baseline in 180 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.53" spread="0.116"/>
                    <measurement group_id="O2" value="-0.53" spread="0.127"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from baseline in 240 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.72" spread="0.131"/>
                    <measurement group_id="O2" value="-0.59" spread="0.143"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Body Temperature Reduction</title>
        <description>Summary statistics for body temperature was presented at baseline and at 15, 30, 60, 120,180 and 240 minutes post treatment. Wilcoxon Rank Sum test was used to investigate if there are any significant treatment differences.</description>
        <time_frame>Change from baseline in 15, 30, 60,120, 180, and 240 minutes</time_frame>
        <population>The primary population for assessment of efficacy was the intent to treat (ITT) population. The ITT population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.</population>
        <group_list>
          <group group_id="O1">
            <title>Test Tablet</title>
            <description>Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Matching placebo tablet</description>
          </group>
        </group_list>
        <measure>
          <title>Body Temperature Reduction</title>
          <description>Summary statistics for body temperature was presented at baseline and at 15, 30, 60, 120,180 and 240 minutes post treatment. Wilcoxon Rank Sum test was used to investigate if there are any significant treatment differences.</description>
          <population>The primary population for assessment of efficacy was the intent to treat (ITT) population. The ITT population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.</population>
          <units>°C (degree Celsius)</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change from baseline to 15 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.02" spread="0.070"/>
                    <measurement group_id="O2" value="0.01" spread="0.047"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from baseline to 30 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.03" spread="0.080"/>
                    <measurement group_id="O2" value="-0.01" spread="0.071"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from baseline to 60 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.04" spread="0.081"/>
                    <measurement group_id="O2" value="0.01" spread="0.049"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from baseline to 120 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.09" spread="0.079"/>
                    <measurement group_id="O2" value="-0.04" spread="0.065"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from baseline to 180 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.14" spread="0.060"/>
                    <measurement group_id="O2" value="-0.09" spread="0.067"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from baseline to 240 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.08" spread="0.058"/>
                    <measurement group_id="O2" value="-0.11" spread="0.066"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>AEs were collected from the start of the study until 5 days following last administration of the investigational product</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Test Tablet</title>
          <description>Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>Matching placebo tablet</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="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>1</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>GINGIVAL SWELLING</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>NAUSEA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>DIZZINESS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>SOMNOLENCE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </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>GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>GSK Response Center</name_or_title>
      <organization>GlaxoSmithKline</organization>
      <phone>866-435-7343</phone>
    </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/NCT02246166
org study id: 202271
secondary id: RH02565
nct id: NCT02246166
lead sponsor: 
collaborator: 
has dmc: No
This phase IV multi-centre, randomised, double-blind, placebo-controlled, parallel-group,
      single-dose study will assess the efficacy and tolerability of the active tablets versus
      placebo in participants suffering from cold and influenza. Eligible participants will be
      randomly assigned to one of 2 treatment groups (active or placebo tablets) and enter a
      four-hour (hr) treatment phase. Each participant will be administered only once during each
      study period. Participants will use a questionnaire to record the symptom severity scores as
      described, as well as time.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Symptom Severity Assessment at 15 Minutes
time frame: 15 minutes
description: Symptom severity assessment was determined by Total Sum Score (TSS), TSS ranged from 0 to 21 with less severity score at the given time point represented a better outcome measure.
TSS was calculated as the sum of the non missing scores (all on a 0-3 scale measuring worsening or severity) of the following common cold symptoms: sore throat, headache, extremities pain, nasal congestion, runny nose, sneezing, and cough post treatment administration.
Participants self assessed symptoms severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at 15 minutes post product use.
measure: Symptom Severity Assessment at 30 Minutes
time frame: 30 minutes
description: Symptom severity assessment was determined by TSS, TSS ranged from 0 to 21 with less severity score at the given time point represented a better outcome measure.
TSS was calculated as the sum of the non missing scores (all on a 0-3 scale measuring worsening or severity) of the following common cold symptoms: sore throat, headache, extremities pain, nasal congestion, runny nose, sneezing, and cough post treatment administration.
Participants self assessed symptoms severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at 30 minutes post product use.
measure: Symptom Severity Assessment at 1 Hour
time frame: 1 hour
description: Symptom severity assessment was determined by TSS, TSS ranged from 0 to 21 with less severity score at the given time point represented a better outcome measure.
TSS was calculated as the sum of the non missing scores (all on a 0-3 scale measuring worsening or severity) of the following common cold symptoms: sore throat, headache, extremities pain, nasal congestion, runny nose, sneezing, and cough post treatment administration.
Participants self assessed symptoms severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at 1hour post product use.
measure: Symptom Severity Assessment at 2 Hours
time frame: 2 hours
description: Symptom severity assessment was determined by TSS, TSS ranged from 0 to 21 with less severity score at the given time point represented a better outcome measure.
TSS was calculated as the sum of the non missing scores (all on a 0-3 scale measuring worsening or severity) of the following common cold symptoms: sore throat, headache, extremities pain, nasal congestion, runny nose, sneezing, and cough post treatment administration.
Participants self assessed symptoms severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at 2 hours post product use.
measure: Symptom Severity Assessment at 3 Hours
time frame: 3 hours
description: Symptom severity assessment was determined by TSS, TSS ranged from 0 to 21 with less severity score at the given time point represented a better outcome measure.
TSS was calculated as the sum of the non missing scores (all on a 0-3 scale measuring worsening or severity) of the following common cold symptoms: sore throat, headache, extremities pain, nasal congestion, runny nose, sneezing, and cough post treatment administration.
Participants self assessed symptoms severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at 3 hours post product use.
measure: Symptom Severity Assessment at 4 Hours
time frame: 4 hours
description: Symptom severity assessment was determined by TSS, TSS ranged from 0 to 21 with less severity score at the given time point represented a better outcome measure.
TSS was calculated as the sum of the non missing scores (all on a 0-3 scale measuring worsening or severity) of the following common cold symptoms: sore throat, headache, extremities pain, nasal congestion, runny nose, sneezing, and cough post treatment administration.
Participants self assessed symptoms severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at 4 hours post product use.
measure: Global Assessment of Treatment
time frame: 4 hours
description: After completing the 4 hours symptom severity assessments, participants evaluated their treatment response on a 5-point scale by answering the question: "How well did the test medication control your symptoms?" (0-ineffective, 1-poor, 2-fair, 3-good, or 4-excellent).
measure: Sore Throat Severity Assessment
time frame: Change from baseline in 15, 30, 60,120, 180, and 240 minutes
description: Participants self-assessed sore throat severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 15, 30, 60, 120,180 and 240 minutes post product administration. All sore throat severity assessment values were recorded in questionnaire and tabulated. A reduction in severity score from baseline represented a better outcome measure.
measure: Headache Severity Assessment
time frame: Change from baseline in 15, 30, 60,120, 180, and 240 minutes
description: Participants self-assessed headache severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 15, 30, 60, 120,180 and 240 minutes post product administration. All headache severity assessment values were recorded in questionnaire and tabulated. A reduction in severity score from baseline represented a better outcome measure.
measure: Extremities Pain Severity Assessment
time frame: Change from baseline in 15, 30, 60,120, 180, and 240 minutes
description: Participants self-assessed extremities pain severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 15, 30, 60, 120,180 and 240 minutes post product administration. All extremities pain severity assessment values were recorded in a questionnaire and tabulated. A reduction in severity score from baseline represented a better outcome measure.
measure: Nasal Congestion Severity Assessment
time frame: Change from baseline in 15, 30, 60,120, 180, and 240 minutes
description: Participants self-assessed nasal congestion severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 15, 30, 60, 120,180 and 240 minutes post product administration. All nasal congestion severity assessment values were recorded in a questionnaire and tabulated. A reduction in severity score from baseline represented a better outcome measure.
measure: Runny Nose Severity Assessment
time frame: Change from baseline in 15, 30, 60,120, 180, and 240 minutes
description: Participants self-assessed runny nose severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 15, 30, 60, 120,180 and 240 minutes post product administration. All runny nose severity assessment values were recorded in questionnaire and tabulated. A reduction in severity score from baseline represented a better outcome measure.
measure: Sneezing Severity Assessment
time frame: Change from baseline in 15, 30, 60,120, 180, and 240 minutes
description: Participants self-assessed sneezing severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 15, 30, 60, 120,180 and 240 minutes post product administration. All sneezing severity assessment values were recorded in a questionnaire and tabulated. A reduction in severity score from baseline represented a better outcome measure.
measure: Cough Severity Assessment
time frame: Change from baseline in 15, 30, 60,120, 180, and 240 minutes
description: Participants self-assessed cough severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 15, 30, 60, 120,180 and 240 minutes post product administration. All cough severity assessment values were recorded in a questionnaire and tabulated. A reduction in severity score from baseline represented a better outcome measure.
measure: Body Temperature Reduction
time frame: Change from baseline in 15, 30, 60,120, 180, and 240 minutes
description: Summary statistics for body temperature was presented at baseline and at 15, 30, 60, 120,180 and 240 minutes post treatment. Wilcoxon Rank Sum test was used to investigate if there are any significant treatment differences.
arm group label: Test tablet
arm group type: Experimental
description: Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).
arm group label: Placebo
arm group type: Placebo Comparator
description: Matching placebo tablet
intervention type: Drug
intervention name: Test tablet
description: The active tablet will be administered orally. Product administration will occur within 30mins of the baseline assessment of symptom severity
arm group label: Test tablet
intervention type: Other
intervention name: Placebo
description: The placebo tablet will be administered orally. Product administration will occur within 30mins of the baseline assessment of symptom severity
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: GSK Clinical Trials
role: Study Director
affiliation: GlaxoSmithKline
facility: 
facility: 
country: China
responsible party type: Sponsor
mesh term: Common Cold
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 