<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/NCT01686646</url>
  </required_header>
  <id_info>
    <org_study_id>RH01361</org_study_id>
    <nct_id>NCT01686646</nct_id>
  </id_info>
  <brief_title>Effects of Two Doses of a Common Cold Treatment on Alertness</brief_title>
  <official_title>Effects of Two Doses of a Common Cold Treatment on Cognitive Function</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GlaxoSmithKline</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>GlaxoSmithKline</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will investigate any improvement in alertness and performance based on cognitive&#xD;
      function and mood assessment in subjects suffering the common cold, when taking a novel&#xD;
      paracetamol and caffeine combination verses paracetamol alone.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2011</start_date>
  <completion_date type="Actual">November 2012</completion_date>
  <primary_completion_date type="Actual">November 2012</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline in Number of Accurate Responses to Rapid Visual Information Processing (RVIP) Cognitive Test</measure>
    <time_frame>Baseline to 60 minutes post treatment administration</time_frame>
    <description>The RVIP assessed the performance of visual attention mechanisms in remaining vigilant to periodically occurring events. The number of accurate responses to RVIP task was determined from the cognitive function computerised output. Participants monitored a series of single numbers (0-9) appearing in the centre of the screen. During the RVIP task, participants responded to consecutive sequences of three odd or three even numbers by pressing the corresponding response button as quickly and accurately as possible. This was identified in the output file by a value of '1' in 'TARGET=1' column. Also, the response time (in seconds) was recorded in the 'RT' column. If the subject correctly responded to the target, this was identified by a value of '1' in the 'CORRECT=1' column. The number of accurate responses was calculated as the total number of records where 'CORRECT=1' had a value of '1'. The test lasted approximately 9 minutes and number of accurate responses to stimulus was calculated.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Number of Accurate Responses to RVIP Cognitive Test</measure>
    <time_frame>Baseline to 120 minutes post treatment administration</time_frame>
    <description>The RVIP assessed the performance of visual attention mechanisms in remaining vigilant to periodically occurring events. The number of accurate responses to RVIP task was determined from the cognitive function computerised output. Participants monitored a series of single numbers (0-9) appearing in the centre of the screen. During the RVIP task, participants responded to consecutive sequences of three odd or three even numbers by pressing the corresponding response button as quickly and accurately as possible. This was identified in the output file by a value of '1' in 'TARGET=1' column. Also, the response time (in seconds) was recorded in the 'RT' column. If the subject correctly responded to the target, this was identified by a value of '1' in the 'CORRECT=1' column. The number of accurate responses was calculated as the total number of records where 'CORRECT=1' had a value of '1'. The test lasted approximately 9 minutes and number of accurate responses to stimulus was calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Mean Time of Accurate Responses to RVIP Cognitive Task</measure>
    <time_frame>Baseline, 60 minutes and upto 120 minutes post treatment administration</time_frame>
    <description>The mean time of accurate responses was defined as the mean reaction time for the correct responses. For records with '1' in the 'CORRECT=1' column, the mean time of accurate response was calculated as the summation of the response time values divided by number of records with '1' in the 'CORRECT=1' column. The result was multiplied by 1000 to convert into milliseconds (msecs).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Number of Inaccurate and Missed Responses to RVIP Cognitive Task</measure>
    <time_frame>Baseline, 60 minutes and up to 120 minutes post treatment administration</time_frame>
    <description>The no. of inaccurate responses to RVIP was determined from cognitive function computerised output. Participants monitored a series of single numbers (0-9) appearing in the centre of screen. They responded to consecutive sequences of 3 odd or even numbers by pressing the corresponding response button. This was identified in the output file by a value of '1' in the 'TARGET=1' column. If a subject responded incorrectly to stimuli (pressed the response button at the wrong time), this was identified by a value of '-1' in the 'CORRECT=1' column. The no. of incorrect responses was calculated as the total no. of records where 'CORRECT=1' had a value of '-1'. If the subject missed a target (failed to press the response button within 600 msecs of being presented with a string of 3 consecutive even or odd numbers), this was considered a missed response and was calculated as the no. of records where there was a value of '1' in the 'TARGET=1' column and a value of '0' in the 'CORRECT=1' column.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Number of Accurate Responses to Sustained Attention Tasks (SAT) Cognitive Test</measure>
    <time_frame>Baseline, 60 minutes and up to 120 minutes post treatment administration</time_frame>
    <description>Auditory and visual attention of participants was evaluated using a validated Sustained Attention task. For the sustained auditory attention task, participants were required to respond whenever they heard the number '8' in a continuous stream of numbers presented through headphones. This was identified in the output file by a value of '8' in the 'NUMBER' column. For the sustained visual attention task, participants were required to respond to the letter 's' every time it appeared in a continuous stream of letters presented on a screen. This was identified in the output file by a value of 's' in the 'LETTER' column. If the subject correctly responded to the target, this was identified by a value of '1' in the 'CORRECT=1' column. The number of accurate responses was calculated as the total number of records where 'CORRECT=1' had a value of '1'.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Mean Time of Accurate Responses to SAT Cognitive Task</measure>
    <time_frame>Baseline, 30 minutes and up to 60 minutes post treatment administration</time_frame>
    <description>The mean time of accurate responses was defined as the mean reaction time for the correct responses. For records with '1' in the 'CORRECT=1' column, the mean time of accurate response was calculated as the summation of the response time values divided by number of records with '1' in the 'CORRECT=1' column. The result was multiplied by 1000 to convert into milliseconds (msecs).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Number of Incorrect and Missed Responses to SAT Cognitive Test</measure>
    <time_frame>Baseline, 60 minutes and up to 120 minutes post treatment administration</time_frame>
    <description>For sustained auditory attention task, participants were required to respond on hearing the no. '8' in a continuous stream of numbers through headphones. It was identified in output file by a value of '8' in 'NUMBER' column. For sustained visual attention task, participants responded to letter 's' every time it appeared in a continuous stream of letters presented on screen. This was identified in output file by a value of 's' in 'LETTER' column. If a subject responded incorrectly (pressed the response button at the wrong time), it was identified by a value of '-1' in 'CORRECT=1' column. The no. of incorrect responses was calculated as total no. of records where 'CORRECT=1' had a value of '-1'. The no. of missed responses (when subject failed to press the response button on hearing the number '8' or seeing the letter 's'), was calculated as the no. of records where there was a value of '8' in 'NUMBER' column or 's' in the 'LETTER' column and a value of '0' in the 'CORRECT=1' column.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Number of Valid Responses to Divided Attention Task (DAT) Cognitive Test</measure>
    <time_frame>Baseline, 60 minutes and up to 120 minutes post treatment administration</time_frame>
    <description>Auditory and visual attention of participants was evaluated using a validated Divided Attention task. Participants were required to respond whenever they heard the number '8' in a continuous stream of numbers presented through headphones or saw a letter 's' on the screen . This was identified in the output file by a value of '8' in the 'NUMBER' column or by a value of 's' in the 'LETTER' column. If the subject correctly responded to the target, this was identified by a value of '1' in the 'CORRECT=1' column. The number of accurate responses was calculated as the total number of records where 'CORRECT=1' had a value of '1'.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Mean Time of Accurate Responses to DAT Cognitive Test</measure>
    <time_frame>Baseline, 60 minutes and up to 120 minutes post treatment administration</time_frame>
    <description>The mean time of accurate responses was defined as the mean reaction time for the correct responses. For records with '1' in the 'CORRECT=1' column, the mean time of accurate response was calculated as the summation of the response time values divided by number of records with '1' in the 'CORRECT=1' column. The result was multiplied by 1000 to convert into milliseconds (msecs).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Number of Incorrect and Missed Responses to DAT Cognitive Test</measure>
    <time_frame>Baseline, 60 minutes and up to 120 minutes post treatment administration</time_frame>
    <description>For the Divided Attention task, participants were required to respond on hearing the no. '8' in a continuous stream of numbers through headphones or seeing a letter 's' on screen. This was identified in the output file by a value of '8' in 'NUMBER' column or 's' in 'LETTER' column. If a subject responded incorrectly (pressed the response button at the wrong time), this was identified by a value of '-1' in 'CORRECT=1' column. The number of incorrect responses was calculated as the total no. of records where 'CORRECT=1' had a value of '-1'. If the subject missed a target (failed to press the response button on hearing the no. '8' or seeing the letter 's'), this was considered a missed response. The number of missed responses was calculated as the no. of records where there was a value of '8' in 'NUMBER' column or 's' in 'LETTER' column and a value of '0' in the 'CORRECT=1' column.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">240</enrollment>
  <condition>Common Cold</condition>
  <arm_group>
    <arm_group_label>highest dose Paracetamol + caffeine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>highest dose of Paracetamol and caffeine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>low-dose Paracetamol + caffeine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>lowest dose of Paracetamol and caffeine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>high dose paracetamol</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>highest dose paracetamol</description>
  </arm_group>
  <arm_group>
    <arm_group_label>low dose paracetamol</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>lowest dose paracetamol</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>paracetamol + caffeine</intervention_name>
    <description>paracetamol with caffeine</description>
    <arm_group_label>highest dose Paracetamol + caffeine</arm_group_label>
    <arm_group_label>low-dose Paracetamol + caffeine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>paracetamol</intervention_name>
    <description>paracetamol</description>
    <arm_group_label>high dose paracetamol</arm_group_label>
    <arm_group_label>low dose paracetamol</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        -  Participants with symptoms of cold &lt; 96 hours, rating of at least '2' on malaise at&#xD;
             least 4 other symptoms of cold.&#xD;
&#xD;
          -  No history of clinically significant perennial rhinitis, no recent antibiotic,&#xD;
             antihistamine or cold treatment, no caffeine in the previous 12 hours, no psychoactive&#xD;
             medication in the 14 days prior to screening, no pregnancy, breastfeeding or&#xD;
             participation in this trial, or another trial in the 30 days prior to screening.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</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>Common Cold Centre</name>
      <address>
        <city>Cardiff</city>
        <state>Wales</state>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>September 13, 2012</study_first_submitted>
  <study_first_submitted_qc>September 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 18, 2012</study_first_posted>
  <results_first_submitted>August 29, 2013</results_first_submitted>
  <results_first_submitted_qc>July 10, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">July 14, 2014</results_first_posted>
  <last_update_submitted>November 20, 2014</last_update_submitted>
  <last_update_submitted_qc>November 20, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 8, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>alertness</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Common Cold</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acetaminophen</mesh_term>
    <mesh_term>Caffeine</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants were recruited at the clinical site.</recruitment_details>
      <pre_assignment_details>Out of 244 participants screened, 4 did not meet the study criteria. Remaining 240 were randomized into the study.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Paracetamol + Caffeine Combination (1000/130)</title>
          <description>Two paracetamol (500 milligrams [mg] ) and caffeine (65 mg) tablets were dissolved in 200 milliliter (mL) of water and administered orally.</description>
        </group>
        <group group_id="P2">
          <title>Paracetamol (1000)</title>
          <description>Two paracetamol tablets (500 mg each) were dissolved in 200 mL of water and administered orally.</description>
        </group>
        <group group_id="P3">
          <title>Paracetamol + Caffeine Combination (500/65)</title>
          <description>One paracetamol (500 mg) and caffeine (65 mg) tablet was dissolved in 200 mL of water and administered orally.</description>
        </group>
        <group group_id="P4">
          <title>Paracetamol (500)</title>
          <description>One paracetamol tablet (500 mg) was dissolved in 200 mL of water and administered orally.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="45"/>
                <participants group_id="P2" count="45"/>
                <participants group_id="P3" count="75"/>
                <participants group_id="P4" count="75"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Intent to Treat Population</title>
              <participants_list>
                <participants group_id="P1" count="45"/>
                <participants group_id="P2" count="45"/>
                <participants group_id="P3" count="75"/>
                <participants group_id="P4" count="75"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Safety Population</title>
              <participants_list>
                <participants group_id="P1" count="46">One subject randomized to Paracetamol+Caffeine (500/65) group but received 1000/130 combination.</participants>
                <participants group_id="P2" count="45"/>
                <participants group_id="P3" count="74"/>
                <participants group_id="P4" count="75"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="45"/>
                <participants group_id="P2" count="45"/>
                <participants group_id="P3" count="75"/>
                <participants group_id="P4" count="75"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Paracetamol + Caffeine Combination (1000/130)</title>
          <description>Two paracetamol (500 mg) and caffeine (65 mg) tablets were dissolved in 200 mL of water and administered orally.</description>
        </group>
        <group group_id="B2">
          <title>Paracetamol (1000)</title>
          <description>Two paracetamol tablets (500 mg each) were dissolved in 200 mL of water and administered orally.</description>
        </group>
        <group group_id="B3">
          <title>Paracetamol + Caffeine Combination (500/65)</title>
          <description>One paracetamol (500 mg) and caffeine (65 mg) tablet was dissolved in 200 mL of water and administered orally.</description>
        </group>
        <group group_id="B4">
          <title>Paracetamol (500)</title>
          <description>One paracetamol tablet (500 mg) was dissolved in 200 mL of water and administered orally.</description>
        </group>
        <group group_id="B5">
          <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="46"/>
            <count group_id="B2" value="45"/>
            <count group_id="B3" value="74"/>
            <count group_id="B4" value="75"/>
            <count group_id="B5" value="240"/>
          </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="20.0" spread="1.56"/>
                    <measurement group_id="B2" value="20.0" spread="1.74"/>
                    <measurement group_id="B3" value="20.6" spread="4.19"/>
                    <measurement group_id="B4" value="20.2" spread="2.80"/>
                    <measurement group_id="B5" value="20.2" spread="2.98"/>
                  </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="31"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="47"/>
                    <measurement group_id="B4" value="48"/>
                    <measurement group_id="B5" value="154"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="27"/>
                    <measurement group_id="B4" value="27"/>
                    <measurement group_id="B5" value="86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Number of Accurate Responses to Rapid Visual Information Processing (RVIP) Cognitive Test</title>
        <description>The RVIP assessed the performance of visual attention mechanisms in remaining vigilant to periodically occurring events. The number of accurate responses to RVIP task was determined from the cognitive function computerised output. Participants monitored a series of single numbers (0-9) appearing in the centre of the screen. During the RVIP task, participants responded to consecutive sequences of three odd or three even numbers by pressing the corresponding response button as quickly and accurately as possible. This was identified in the output file by a value of '1' in 'TARGET=1' column. Also, the response time (in seconds) was recorded in the 'RT' column. If the subject correctly responded to the target, this was identified by a value of '1' in the 'CORRECT=1' column. The number of accurate responses was calculated as the total number of records where 'CORRECT=1' had a value of '1'. The test lasted approximately 9 minutes and number of accurate responses to stimulus was calculated.</description>
        <time_frame>Baseline to 60 minutes post treatment administration</time_frame>
        <population>Intent to Treat (ITT) population: all randomized participants who received study treatment and had at least one post-baseline efficacy evaluation.</population>
        <group_list>
          <group group_id="O1">
            <title>Paracetamol + Caffeine Combination (1000/130)</title>
            <description>Two paracetamol (500 mg) and caffeine (65 mg) tablets were dissolved in 200 mL of water and administered orally.</description>
          </group>
          <group group_id="O2">
            <title>Paracetamol (1000)</title>
            <description>Two paracetamol tablets (500 mg each) were dissolved in 200 mL of water and administered orally.</description>
          </group>
          <group group_id="O3">
            <title>Paracetamol + Caffeine Combination (500/65)</title>
            <description>One paracetamol (500 mg) and caffeine (65 mg) tablet was dissolved in 200 mL of water and administered orally.</description>
          </group>
          <group group_id="O4">
            <title>Paracetamol (500)</title>
            <description>One paracetamol tablet (500 mg) was dissolved in 200 mL of water and administered orally.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Number of Accurate Responses to Rapid Visual Information Processing (RVIP) Cognitive Test</title>
          <description>The RVIP assessed the performance of visual attention mechanisms in remaining vigilant to periodically occurring events. The number of accurate responses to RVIP task was determined from the cognitive function computerised output. Participants monitored a series of single numbers (0-9) appearing in the centre of the screen. During the RVIP task, participants responded to consecutive sequences of three odd or three even numbers by pressing the corresponding response button as quickly and accurately as possible. This was identified in the output file by a value of '1' in 'TARGET=1' column. Also, the response time (in seconds) was recorded in the 'RT' column. If the subject correctly responded to the target, this was identified by a value of '1' in the 'CORRECT=1' column. The number of accurate responses was calculated as the total number of records where 'CORRECT=1' had a value of '1'. The test lasted approximately 9 minutes and number of accurate responses to stimulus was calculated.</description>
          <population>Intent to Treat (ITT) population: all randomized participants who received study treatment and had at least one post-baseline efficacy evaluation.</population>
          <units>Correct responses</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="45"/>
                <count group_id="O2" value="45"/>
                <count group_id="O3" value="75"/>
                <count group_id="O4" value="75"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.3" spread="1.12"/>
                    <measurement group_id="O2" value="4.8" spread="1.12"/>
                    <measurement group_id="O3" value="4.5" spread="0.89"/>
                    <measurement group_id="O4" value="2.7" spread="0.88"/>
                  </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>
            <groups_desc>Null hypothesis was no difference in treatments in the change from baseline in the number of valid responses from the RVIP.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0248</p_value>
            <p_value_desc>A hierarchical testing procedure was used such that p-values were only presented if the preceding treatment comparison was statistically significant (p&lt;0.05).</p_value_desc>
            <method>ANCOVA</method>
            <method_desc>From ANCOVA model with factors for treatment group and season, and baseline score as a covariate.</method_desc>
            <param_type>LS Mean DIfference</param_type>
            <param_value>3.5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.4</ci_lower_limit>
            <ci_upper_limit>6.5</ci_upper_limit>
            <estimate_desc>A positive difference favored the first named treatment.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Null hypothesis was no difference in treatments in the change from baseline in the number of valid responses from the RVIP.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.1513</p_value>
            <p_value_desc>A hierarchical testing procedure was used such that p-values were only presented if the preceding treatment comparison was statistically significant (p&lt;0.05).</p_value_desc>
            <method>ANCOVA</method>
            <method_desc>From ANCOVA model with factors for treatment group and season, and baseline score as a covariate.</method_desc>
            <param_type>LS Mean Difference</param_type>
            <param_value>1.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.6</ci_lower_limit>
            <ci_upper_limit>4.1</ci_upper_limit>
            <estimate_desc>A positive difference favoured the first named treatment.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Null hypothesis was no difference in treatments in change from baseline in number of valid responses from RVIP task.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>3.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.1</ci_lower_limit>
            <ci_upper_limit>6.6</ci_upper_limit>
            <estimate_desc>A positive difference favoured the first named treatment.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Number of Accurate Responses to RVIP Cognitive Test</title>
        <description>The RVIP assessed the performance of visual attention mechanisms in remaining vigilant to periodically occurring events. The number of accurate responses to RVIP task was determined from the cognitive function computerised output. Participants monitored a series of single numbers (0-9) appearing in the centre of the screen. During the RVIP task, participants responded to consecutive sequences of three odd or three even numbers by pressing the corresponding response button as quickly and accurately as possible. This was identified in the output file by a value of '1' in 'TARGET=1' column. Also, the response time (in seconds) was recorded in the 'RT' column. If the subject correctly responded to the target, this was identified by a value of '1' in the 'CORRECT=1' column. The number of accurate responses was calculated as the total number of records where 'CORRECT=1' had a value of '1'. The test lasted approximately 9 minutes and number of accurate responses to stimulus was calculated.</description>
        <time_frame>Baseline to 120 minutes post treatment administration</time_frame>
        <population>ITT population: all randomized participants who received study treatment and had at least one post-baseline efficacy evaluation.</population>
        <group_list>
          <group group_id="O1">
            <title>Paracetamol + Caffeine Combination (1000/130)</title>
            <description>Two paracetamol (500 mg) and caffeine (65 mg) tablets were dissolved in 200 mL of water and administered orally.</description>
          </group>
          <group group_id="O2">
            <title>Paracetamol (1000)</title>
            <description>Two paracetamol tablets (500 mg each) were dissolved in 200 mL of water and administered orally.</description>
          </group>
          <group group_id="O3">
            <title>Paracetamol + Caffeine Combination (500/65)</title>
            <description>One paracetamol (500 mg) and caffeine (65 mg) tablet was dissolved in 200 mL of water and administered orally.</description>
          </group>
          <group group_id="O4">
            <title>Paracetamol (500)</title>
            <description>One paracetamol tablet (500 mg) was dissolved in 200 mL of water and administered orally.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Number of Accurate Responses to RVIP Cognitive Test</title>
          <description>The RVIP assessed the performance of visual attention mechanisms in remaining vigilant to periodically occurring events. The number of accurate responses to RVIP task was determined from the cognitive function computerised output. Participants monitored a series of single numbers (0-9) appearing in the centre of the screen. During the RVIP task, participants responded to consecutive sequences of three odd or three even numbers by pressing the corresponding response button as quickly and accurately as possible. This was identified in the output file by a value of '1' in 'TARGET=1' column. Also, the response time (in seconds) was recorded in the 'RT' column. If the subject correctly responded to the target, this was identified by a value of '1' in the 'CORRECT=1' column. The number of accurate responses was calculated as the total number of records where 'CORRECT=1' had a value of '1'. The test lasted approximately 9 minutes and number of accurate responses to stimulus was calculated.</description>
          <population>ITT population: all randomized participants who received study treatment and had at least one post-baseline efficacy evaluation.</population>
          <units>Correct responses</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="45"/>
                <count group_id="O2" value="45"/>
                <count group_id="O3" value="75"/>
                <count group_id="O4" value="75"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.3" spread="1.16"/>
                    <measurement group_id="O2" value="4.4" spread="1.15"/>
                    <measurement group_id="O3" value="6.2" spread="0.91"/>
                    <measurement group_id="O4" value="3.5" spread="0.92"/>
                  </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>
            <groups_desc>Null hypothesis was no difference in treatments in the change from baseline in the number of accurate responses from the RVIP.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0696</p_value>
            <p_value_desc>A hierarchical testing procedure was used such that p-values were only presented if the preceding treatment comparison was statistically significant (p&lt;0.05).</p_value_desc>
            <method>ANCOVA</method>
            <method_desc>From ANCOVA model with factors for treatment group and season, and baseline score as a covariate.</method_desc>
            <param_type>LS Mean Difference</param_type>
            <param_value>2.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.2</ci_lower_limit>
            <ci_upper_limit>6.1</ci_upper_limit>
            <estimate_desc>A positive difference favored the first named treatment.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Null hypothesis was no difference in treatments in the change from baseline in the number of valid responses from the RVIP.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>2.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.3</ci_lower_limit>
            <ci_upper_limit>5.2</ci_upper_limit>
            <estimate_desc>A positive difference favored the first named treatment.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Null hypothesis was no difference in treatments in the change from baseline in the number of valid responses from the RVIP.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>1.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.7</ci_lower_limit>
            <ci_upper_limit>3.9</ci_upper_limit>
            <estimate_desc>A positive difference favored the first named treatment.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Mean Time of Accurate Responses to RVIP Cognitive Task</title>
        <description>The mean time of accurate responses was defined as the mean reaction time for the correct responses. For records with '1' in the 'CORRECT=1' column, the mean time of accurate response was calculated as the summation of the response time values divided by number of records with '1' in the 'CORRECT=1' column. The result was multiplied by 1000 to convert into milliseconds (msecs).</description>
        <time_frame>Baseline, 60 minutes and upto 120 minutes post treatment administration</time_frame>
        <population>ITT population: all randomized participants who received study treatment and had at least one post-baseline efficacy evaluation.</population>
        <group_list>
          <group group_id="O1">
            <title>Paracetamol + Caffeine Combination (1000/130)</title>
            <description>Two paracetamol (500 mg) and caffeine (65 mg) tablets were dissolved in 200 mL of water and administered orally.</description>
          </group>
          <group group_id="O2">
            <title>Paracetamol (1000)</title>
            <description>Two paracetamol tablets (500 mg each) were dissolved in 200 mL of water and administered orally.</description>
          </group>
          <group group_id="O3">
            <title>Paracetamol + Caffeine Combination (500/65)</title>
            <description>One paracetamol (500 mg) and caffeine (65 mg) tablet was dissolved in 200 mL of water and administered orally.</description>
          </group>
          <group group_id="O4">
            <title>Paracetamol (500)</title>
            <description>One paracetamol tablet (500 mg) was dissolved in 200 mL of water and administered orally.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Mean Time of Accurate Responses to RVIP Cognitive Task</title>
          <description>The mean time of accurate responses was defined as the mean reaction time for the correct responses. For records with '1' in the 'CORRECT=1' column, the mean time of accurate response was calculated as the summation of the response time values divided by number of records with '1' in the 'CORRECT=1' column. The result was multiplied by 1000 to convert into milliseconds (msecs).</description>
          <population>ITT population: all randomized participants who received study treatment and had at least one post-baseline efficacy evaluation.</population>
          <units>milliseconds (msec)</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
                <count group_id="O2" value="45"/>
                <count group_id="O3" value="75"/>
                <count group_id="O4" value="75"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>60 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.4" lower_limit="-92" upper_limit="102"/>
                    <measurement group_id="O2" value="2.4" lower_limit="-113" upper_limit="313"/>
                    <measurement group_id="O3" value="-0.9" lower_limit="-134" upper_limit="119"/>
                    <measurement group_id="O4" value="-9.9" lower_limit="-108" upper_limit="142"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>120 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-10.3" lower_limit="-62" upper_limit="125"/>
                    <measurement group_id="O2" value="-6.0" lower_limit="-86" upper_limit="71"/>
                    <measurement group_id="O3" value="-12.5" lower_limit="-91" upper_limit="109"/>
                    <measurement group_id="O4" value="-14.0" lower_limit="-144" upper_limit="136"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Number of Inaccurate and Missed Responses to RVIP Cognitive Task</title>
        <description>The no. of inaccurate responses to RVIP was determined from cognitive function computerised output. Participants monitored a series of single numbers (0-9) appearing in the centre of screen. They responded to consecutive sequences of 3 odd or even numbers by pressing the corresponding response button. This was identified in the output file by a value of '1' in the 'TARGET=1' column. If a subject responded incorrectly to stimuli (pressed the response button at the wrong time), this was identified by a value of '-1' in the 'CORRECT=1' column. The no. of incorrect responses was calculated as the total no. of records where 'CORRECT=1' had a value of '-1'. If the subject missed a target (failed to press the response button within 600 msecs of being presented with a string of 3 consecutive even or odd numbers), this was considered a missed response and was calculated as the no. of records where there was a value of '1' in the 'TARGET=1' column and a value of '0' in the 'CORRECT=1' column.</description>
        <time_frame>Baseline, 60 minutes and up to 120 minutes post treatment administration</time_frame>
        <population>ITT population: all randomized participants who received study treatment and had at least one post-baseline efficacy evaluation.</population>
        <group_list>
          <group group_id="O1">
            <title>Paracetamol + Caffeine Combination (1000/130)</title>
            <description>Two paracetamol (500 mg) and caffeine (65 mg) tablets were dissolved in 200 mL of water and administered orally.</description>
          </group>
          <group group_id="O2">
            <title>Paracetamol (1000)</title>
            <description>Two paracetamol tablets (500 mg each) were dissolved in 200 mL of water and administered orally.</description>
          </group>
          <group group_id="O3">
            <title>Paracetamol + Caffeine Combination (500/65)</title>
            <description>One paracetamol (500 mg) and caffeine (65 mg) tablet was dissolved in 200 mL of water and administered orally.</description>
          </group>
          <group group_id="O4">
            <title>Paracetamol (500)</title>
            <description>One paracetamol tablet (500 mg) was dissolved in 200 mL of water and administered orally.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Number of Inaccurate and Missed Responses to RVIP Cognitive Task</title>
          <description>The no. of inaccurate responses to RVIP was determined from cognitive function computerised output. Participants monitored a series of single numbers (0-9) appearing in the centre of screen. They responded to consecutive sequences of 3 odd or even numbers by pressing the corresponding response button. This was identified in the output file by a value of '1' in the 'TARGET=1' column. If a subject responded incorrectly to stimuli (pressed the response button at the wrong time), this was identified by a value of '-1' in the 'CORRECT=1' column. The no. of incorrect responses was calculated as the total no. of records where 'CORRECT=1' had a value of '-1'. If the subject missed a target (failed to press the response button within 600 msecs of being presented with a string of 3 consecutive even or odd numbers), this was considered a missed response and was calculated as the no. of records where there was a value of '1' in the 'TARGET=1' column and a value of '0' in the 'CORRECT=1' column.</description>
          <population>ITT population: all randomized participants who received study treatment and had at least one post-baseline efficacy evaluation.</population>
          <units>inaccurate and missed responses</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
                <count group_id="O2" value="45"/>
                <count group_id="O3" value="75"/>
                <count group_id="O4" value="75"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Incorrect responses at 60 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.7" spread="3.43"/>
                    <measurement group_id="O2" value="-2.8" spread="1.38"/>
                    <measurement group_id="O3" value="1.4" spread="1.96"/>
                    <measurement group_id="O4" value="-2.4" spread="1.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Incorrect responses at 120 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.5" spread="4.12"/>
                    <measurement group_id="O2" value="-1.7" spread="1.78"/>
                    <measurement group_id="O3" value="-0.8" spread="1.97"/>
                    <measurement group_id="O4" value="-3.3" spread="1.56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Missed responses at 60 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.1" spread="1.03"/>
                    <measurement group_id="O2" value="-4.8" spread="1.18"/>
                    <measurement group_id="O3" value="-4.8" spread="0.83"/>
                    <measurement group_id="O4" value="-3.1" spread="0.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Missed responses at 120 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.6" spread="1.14"/>
                    <measurement group_id="O2" value="-4.8" spread="1.15"/>
                    <measurement group_id="O3" value="-6.5" spread="0.80"/>
                    <measurement group_id="O4" value="-3.5" spread="0.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Number of Accurate Responses to Sustained Attention Tasks (SAT) Cognitive Test</title>
        <description>Auditory and visual attention of participants was evaluated using a validated Sustained Attention task. For the sustained auditory attention task, participants were required to respond whenever they heard the number '8' in a continuous stream of numbers presented through headphones. This was identified in the output file by a value of '8' in the 'NUMBER' column. For the sustained visual attention task, participants were required to respond to the letter 's' every time it appeared in a continuous stream of letters presented on a screen. This was identified in the output file by a value of 's' in the 'LETTER' column. If the subject correctly responded to the target, this was identified by a value of '1' in the 'CORRECT=1' column. The number of accurate responses was calculated as the total number of records where 'CORRECT=1' had a value of '1'.</description>
        <time_frame>Baseline, 60 minutes and up to 120 minutes post treatment administration</time_frame>
        <population>ITT population: all randomized participants who received study treatment and had at least one post-baseline efficacy evaluation.</population>
        <group_list>
          <group group_id="O1">
            <title>Paracetamol + Caffeine Combination (1000/130)</title>
            <description>Two paracetamol (500 mg) and caffeine (65 mg) tablets were dissolved in 200 mL of water and administered orally.</description>
          </group>
          <group group_id="O2">
            <title>Paracetamol (1000)</title>
            <description>Two paracetamol tablets (500 mg each) were dissolved in 200 mL of water and administered orally.</description>
          </group>
          <group group_id="O3">
            <title>Paracetamol + Caffeine Combination (500/65)</title>
            <description>One paracetamol (500 mg) and caffeine (65 mg) tablet was dissolved in 200 mL of water and administered orally.</description>
          </group>
          <group group_id="O4">
            <title>Paracetamol (500)</title>
            <description>One paracetamol tablet (500 mg) was dissolved in 200 mL of water and administered orally.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Number of Accurate Responses to Sustained Attention Tasks (SAT) Cognitive Test</title>
          <description>Auditory and visual attention of participants was evaluated using a validated Sustained Attention task. For the sustained auditory attention task, participants were required to respond whenever they heard the number '8' in a continuous stream of numbers presented through headphones. This was identified in the output file by a value of '8' in the 'NUMBER' column. For the sustained visual attention task, participants were required to respond to the letter 's' every time it appeared in a continuous stream of letters presented on a screen. This was identified in the output file by a value of 's' in the 'LETTER' column. If the subject correctly responded to the target, this was identified by a value of '1' in the 'CORRECT=1' column. The number of accurate responses was calculated as the total number of records where 'CORRECT=1' had a value of '1'.</description>
          <population>ITT population: all randomized participants who received study treatment and had at least one post-baseline efficacy evaluation.</population>
          <units>Correct responses</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
                <count group_id="O2" value="45"/>
                <count group_id="O3" value="75"/>
                <count group_id="O4" value="75"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Number of Accurate Responses to SAT at 60 mins</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" lower_limit="-4" upper_limit="16"/>
                    <measurement group_id="O2" value="0.5" lower_limit="-16" upper_limit="43"/>
                    <measurement group_id="O3" value="2.0" lower_limit="-9" upper_limit="33"/>
                    <measurement group_id="O4" value="0.0" lower_limit="-28" upper_limit="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Number of Accurate Responses to SAT at 120 mins</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" lower_limit="-17" upper_limit="28"/>
                    <measurement group_id="O2" value="1.0" lower_limit="-11" upper_limit="42"/>
                    <measurement group_id="O3" value="1.0" lower_limit="-6" upper_limit="30"/>
                    <measurement group_id="O4" value="2.0" lower_limit="-10" upper_limit="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Mean Time of Accurate Responses to SAT Cognitive Task</title>
        <description>The mean time of accurate responses was defined as the mean reaction time for the correct responses. For records with '1' in the 'CORRECT=1' column, the mean time of accurate response was calculated as the summation of the response time values divided by number of records with '1' in the 'CORRECT=1' column. The result was multiplied by 1000 to convert into milliseconds (msecs).</description>
        <time_frame>Baseline, 30 minutes and up to 60 minutes post treatment administration</time_frame>
        <population>ITT population: all randomized participants who received study treatment and had at least one post-baseline efficacy evaluation.</population>
        <group_list>
          <group group_id="O1">
            <title>Paracetamol + Caffeine Combination (1000/130)</title>
            <description>Two paracetamol (500 mg) and caffeine (65 mg) tablets were dissolved in 200 mL of water and administered orally.</description>
          </group>
          <group group_id="O2">
            <title>Paracetamol (1000)</title>
            <description>Two paracetamol tablets (500 mg each) were dissolved in 200 mL of water and administered orally.</description>
          </group>
          <group group_id="O3">
            <title>Paracetamol + Caffeine Combination (500/65)</title>
            <description>One paracetamol (500 mg) and caffeine (65 mg) tablet was dissolved in 200 mL of water and administered orally.</description>
          </group>
          <group group_id="O4">
            <title>Paracetamol (500)</title>
            <description>One paracetamol tablet (500 mg) was dissolved in 200 mL of water and administered orally.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Mean Time of Accurate Responses to SAT Cognitive Task</title>
          <description>The mean time of accurate responses was defined as the mean reaction time for the correct responses. For records with '1' in the 'CORRECT=1' column, the mean time of accurate response was calculated as the summation of the response time values divided by number of records with '1' in the 'CORRECT=1' column. The result was multiplied by 1000 to convert into milliseconds (msecs).</description>
          <population>ITT population: all randomized participants who received study treatment and had at least one post-baseline efficacy evaluation.</population>
          <units>msec</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="45"/>
                <count group_id="O2" value="45"/>
                <count group_id="O3" value="75"/>
                <count group_id="O4" value="75"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>60 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-16.7" spread="3.17"/>
                    <measurement group_id="O2" value="-9.8" spread="3.17"/>
                    <measurement group_id="O3" value="-10.8" spread="2.51"/>
                    <measurement group_id="O4" value="-12.0" spread="2.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>120 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-21.2" spread="3.48"/>
                    <measurement group_id="O2" value="-10.4" spread="3.48"/>
                    <measurement group_id="O3" value="-18.0" spread="2.74"/>
                    <measurement group_id="O4" value="-15.4" spread="2.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Number of Incorrect and Missed Responses to SAT Cognitive Test</title>
        <description>For sustained auditory attention task, participants were required to respond on hearing the no. '8' in a continuous stream of numbers through headphones. It was identified in output file by a value of '8' in 'NUMBER' column. For sustained visual attention task, participants responded to letter 's' every time it appeared in a continuous stream of letters presented on screen. This was identified in output file by a value of 's' in 'LETTER' column. If a subject responded incorrectly (pressed the response button at the wrong time), it was identified by a value of '-1' in 'CORRECT=1' column. The no. of incorrect responses was calculated as total no. of records where 'CORRECT=1' had a value of '-1'. The no. of missed responses (when subject failed to press the response button on hearing the number '8' or seeing the letter 's'), was calculated as the no. of records where there was a value of '8' in 'NUMBER' column or 's' in the 'LETTER' column and a value of '0' in the 'CORRECT=1' column.</description>
        <time_frame>Baseline, 60 minutes and up to 120 minutes post treatment administration</time_frame>
        <population>ITT population: all randomized participants who received study treatment and had at least one post-baseline efficacy evaluation.</population>
        <group_list>
          <group group_id="O1">
            <title>Paracetamol + Caffeine Combination (1000/130)</title>
            <description>Two paracetamol (500 mg) and caffeine (65 mg) tablets were dissolved in 200 mL of water and administered orally.</description>
          </group>
          <group group_id="O2">
            <title>Paracetamol (1000)</title>
            <description>Two paracetamol tablets (500 mg each) were dissolved in 200 mL of water and administered orally.</description>
          </group>
          <group group_id="O3">
            <title>Paracetamol + Caffeine Combination (500/65)</title>
            <description>One paracetamol (500 mg) and caffeine (65 mg) tablet was dissolved in 200 mL of water and administered orally.</description>
          </group>
          <group group_id="O4">
            <title>Paracetamol (500)</title>
            <description>One paracetamol tablet (500 mg) was dissolved in 200 mL of water and administered orally.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Number of Incorrect and Missed Responses to SAT Cognitive Test</title>
          <description>For sustained auditory attention task, participants were required to respond on hearing the no. '8' in a continuous stream of numbers through headphones. It was identified in output file by a value of '8' in 'NUMBER' column. For sustained visual attention task, participants responded to letter 's' every time it appeared in a continuous stream of letters presented on screen. This was identified in output file by a value of 's' in 'LETTER' column. If a subject responded incorrectly (pressed the response button at the wrong time), it was identified by a value of '-1' in 'CORRECT=1' column. The no. of incorrect responses was calculated as total no. of records where 'CORRECT=1' had a value of '-1'. The no. of missed responses (when subject failed to press the response button on hearing the number '8' or seeing the letter 's'), was calculated as the no. of records where there was a value of '8' in 'NUMBER' column or 's' in the 'LETTER' column and a value of '0' in the 'CORRECT=1' column.</description>
          <population>ITT population: all randomized participants who received study treatment and had at least one post-baseline efficacy evaluation.</population>
          <units>incorrect and missed responses</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
                <count group_id="O2" value="45"/>
                <count group_id="O3" value="75"/>
                <count group_id="O4" value="75"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Incorrect responses at 60 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.6" spread="1.00"/>
                    <measurement group_id="O2" value="-1.1" spread="0.87"/>
                    <measurement group_id="O3" value="-4.2" spread="0.74"/>
                    <measurement group_id="O4" value="-1.6" spread="0.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Incorrect responses at 120 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.4" spread="1.04"/>
                    <measurement group_id="O2" value="-2.3" spread="0.98"/>
                    <measurement group_id="O3" value="-4.3" spread="0.88"/>
                    <measurement group_id="O4" value="-2.8" spread="0.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Missed responses at 60 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.7" spread="0.74"/>
                    <measurement group_id="O2" value="-1.9" spread="1.25"/>
                    <measurement group_id="O3" value="-2.3" spread="0.70"/>
                    <measurement group_id="O4" value="-0.8" spread="0.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Missed responses at 120 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.8" spread="1.11"/>
                    <measurement group_id="O2" value="-2.0" spread="1.19"/>
                    <measurement group_id="O3" value="-2.2" spread="0.64"/>
                    <measurement group_id="O4" value="-2.4" spread="0.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Number of Valid Responses to Divided Attention Task (DAT) Cognitive Test</title>
        <description>Auditory and visual attention of participants was evaluated using a validated Divided Attention task. Participants were required to respond whenever they heard the number '8' in a continuous stream of numbers presented through headphones or saw a letter 's' on the screen . This was identified in the output file by a value of '8' in the 'NUMBER' column or by a value of 's' in the 'LETTER' column. If the subject correctly responded to the target, this was identified by a value of '1' in the 'CORRECT=1' column. The number of accurate responses was calculated as the total number of records where 'CORRECT=1' had a value of '1'.</description>
        <time_frame>Baseline, 60 minutes and up to 120 minutes post treatment administration</time_frame>
        <population>ITT population: all randomized participants who received study treatment and had at least one post-baseline efficacy evaluation.</population>
        <group_list>
          <group group_id="O1">
            <title>Paracetamol + Caffeine Combination (1000/130)</title>
            <description>Two paracetamol (500 mg) and caffeine (65 mg) tablets were dissolved in 200 mL of water and administered orally.</description>
          </group>
          <group group_id="O2">
            <title>Paracetamol (1000)</title>
            <description>Two paracetamol tablets (500 mg each) were dissolved in 200 mL of water and administered orally.</description>
          </group>
          <group group_id="O3">
            <title>Paracetamol + Caffeine Combination (500/65)</title>
            <description>One paracetamol (500 mg) and caffeine (65 mg) tablet was dissolved in 200 mL of water and administered orally.</description>
          </group>
          <group group_id="O4">
            <title>Paracetamol (500)</title>
            <description>One paracetamol tablet (500 mg) was dissolved in 200 mL of water and administered orally.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Number of Valid Responses to Divided Attention Task (DAT) Cognitive Test</title>
          <description>Auditory and visual attention of participants was evaluated using a validated Divided Attention task. Participants were required to respond whenever they heard the number '8' in a continuous stream of numbers presented through headphones or saw a letter 's' on the screen . This was identified in the output file by a value of '8' in the 'NUMBER' column or by a value of 's' in the 'LETTER' column. If the subject correctly responded to the target, this was identified by a value of '1' in the 'CORRECT=1' column. The number of accurate responses was calculated as the total number of records where 'CORRECT=1' had a value of '1'.</description>
          <population>ITT population: all randomized participants who received study treatment and had at least one post-baseline efficacy evaluation.</population>
          <units>Correct responses</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
                <count group_id="O2" value="45"/>
                <count group_id="O3" value="75"/>
                <count group_id="O4" value="75"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>60 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.0" lower_limit="-9" upper_limit="34"/>
                    <measurement group_id="O2" value="6.0" lower_limit="-35" upper_limit="66"/>
                    <measurement group_id="O3" value="8.0" lower_limit="-9" upper_limit="45"/>
                    <measurement group_id="O4" value="5.5" lower_limit="-27" upper_limit="82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>120 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.0" lower_limit="-6" upper_limit="53"/>
                    <measurement group_id="O2" value="6.0" lower_limit="-15" upper_limit="88"/>
                    <measurement group_id="O3" value="9.0" lower_limit="-23" upper_limit="59"/>
                    <measurement group_id="O4" value="7.0" lower_limit="-23" upper_limit="86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Mean Time of Accurate Responses to DAT Cognitive Test</title>
        <description>The mean time of accurate responses was defined as the mean reaction time for the correct responses. For records with '1' in the 'CORRECT=1' column, the mean time of accurate response was calculated as the summation of the response time values divided by number of records with '1' in the 'CORRECT=1' column. The result was multiplied by 1000 to convert into milliseconds (msecs).</description>
        <time_frame>Baseline, 60 minutes and up to 120 minutes post treatment administration</time_frame>
        <population>ITT population: all randomized participants who received study treatment and had at least one post-baseline efficacy evaluation.</population>
        <group_list>
          <group group_id="O1">
            <title>Paracetamol + Caffeine Combination (1000/130)</title>
            <description>Two paracetamol (500 mg) and caffeine (65 mg) tablets were dissolved in 200 mL of water and administered orally.</description>
          </group>
          <group group_id="O2">
            <title>Paracetamol (1000)</title>
            <description>Two paracetamol tablets (500 mg each) were dissolved in 200 mL of water and administered orally.</description>
          </group>
          <group group_id="O3">
            <title>Paracetamol + Caffeine Combination (500/65)</title>
            <description>One paracetamol (500 mg) and caffeine (65 mg) tablet was dissolved in 200 mL of water and administered orally.</description>
          </group>
          <group group_id="O4">
            <title>Paracetamol (500)</title>
            <description>One paracetamol tablet (500 mg) was dissolved in 200 mL of water and administered orally.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Mean Time of Accurate Responses to DAT Cognitive Test</title>
          <description>The mean time of accurate responses was defined as the mean reaction time for the correct responses. For records with '1' in the 'CORRECT=1' column, the mean time of accurate response was calculated as the summation of the response time values divided by number of records with '1' in the 'CORRECT=1' column. The result was multiplied by 1000 to convert into milliseconds (msecs).</description>
          <population>ITT population: all randomized participants who received study treatment and had at least one post-baseline efficacy evaluation.</population>
          <units>msec</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="45"/>
                <count group_id="O2" value="45"/>
                <count group_id="O3" value="75"/>
                <count group_id="O4" value="75"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>60 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.0" spread="2.94"/>
                    <measurement group_id="O2" value="1.5" spread="2.94"/>
                    <measurement group_id="O3" value="-4.4" spread="2.33"/>
                    <measurement group_id="O4" value="-2.2" spread="2.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>120 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-11.0" spread="3.00"/>
                    <measurement group_id="O2" value="-5.3" spread="3.00"/>
                    <measurement group_id="O3" value="-8.0" spread="2.37"/>
                    <measurement group_id="O4" value="-4.6" spread="2.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Number of Incorrect and Missed Responses to DAT Cognitive Test</title>
        <description>For the Divided Attention task, participants were required to respond on hearing the no. '8' in a continuous stream of numbers through headphones or seeing a letter 's' on screen. This was identified in the output file by a value of '8' in 'NUMBER' column or 's' in 'LETTER' column. If a subject responded incorrectly (pressed the response button at the wrong time), this was identified by a value of '-1' in 'CORRECT=1' column. The number of incorrect responses was calculated as the total no. of records where 'CORRECT=1' had a value of '-1'. If the subject missed a target (failed to press the response button on hearing the no. '8' or seeing the letter 's'), this was considered a missed response. The number of missed responses was calculated as the no. of records where there was a value of '8' in 'NUMBER' column or 's' in 'LETTER' column and a value of '0' in the 'CORRECT=1' column.</description>
        <time_frame>Baseline, 60 minutes and up to 120 minutes post treatment administration</time_frame>
        <population>ITT population: all randomized participants who received study treatment and had at least one post-baseline efficacy evaluation.</population>
        <group_list>
          <group group_id="O1">
            <title>Paracetamol + Caffeine Combination (1000/130)</title>
            <description>Two paracetamol (500 mg) and caffeine (65 mg) tablets were dissolved in 200 mL of water and administered orally.</description>
          </group>
          <group group_id="O2">
            <title>Paracetamol (1000)</title>
            <description>Two paracetamol tablets (500 mg each) were dissolved in 200 mL of water and administered orally.</description>
          </group>
          <group group_id="O3">
            <title>Paracetamol + Caffeine Combination (500/65)</title>
            <description>One paracetamol (500 mg) and caffeine (65 mg) tablet was dissolved in 200 mL of water and administered orally.</description>
          </group>
          <group group_id="O4">
            <title>Paracetamol (500)</title>
            <description>One paracetamol tablet (500 mg) was dissolved in 200 mL of water and administered orally.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Number of Incorrect and Missed Responses to DAT Cognitive Test</title>
          <description>For the Divided Attention task, participants were required to respond on hearing the no. '8' in a continuous stream of numbers through headphones or seeing a letter 's' on screen. This was identified in the output file by a value of '8' in 'NUMBER' column or 's' in 'LETTER' column. If a subject responded incorrectly (pressed the response button at the wrong time), this was identified by a value of '-1' in 'CORRECT=1' column. The number of incorrect responses was calculated as the total no. of records where 'CORRECT=1' had a value of '-1'. If the subject missed a target (failed to press the response button on hearing the no. '8' or seeing the letter 's'), this was considered a missed response. The number of missed responses was calculated as the no. of records where there was a value of '8' in 'NUMBER' column or 's' in 'LETTER' column and a value of '0' in the 'CORRECT=1' column.</description>
          <population>ITT population: all randomized participants who received study treatment and had at least one post-baseline efficacy evaluation.</population>
          <units>incorrect and missed responses</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
                <count group_id="O2" value="45"/>
                <count group_id="O3" value="75"/>
                <count group_id="O4" value="75"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Incorrect responses at 60 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.5" spread="1.02"/>
                    <measurement group_id="O2" value="-4.2" spread="1.11"/>
                    <measurement group_id="O3" value="-5.4" spread="0.87"/>
                    <measurement group_id="O4" value="-3.3" spread="0.81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Incorrect responses at 120 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.1" spread="1.01"/>
                    <measurement group_id="O2" value="-4.9" spread="1.10"/>
                    <measurement group_id="O3" value="-5.6" spread="0.86"/>
                    <measurement group_id="O4" value="-5.0" spread="0.98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Missed responses at 60 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-10.2" spread="1.27"/>
                    <measurement group_id="O2" value="-7.6" spread="2.08"/>
                    <measurement group_id="O3" value="-9.8" spread="1.19"/>
                    <measurement group_id="O4" value="-6.2" spread="1.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Missed responses at 120 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-12.2" spread="1.54"/>
                    <measurement group_id="O2" value="-9.1" spread="2.27"/>
                    <measurement group_id="O3" value="-10.2" spread="1.43"/>
                    <measurement group_id="O4" value="-7.8" spread="1.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were collected from the start of the treatment, and until 5 days following administration of the last dose of investigational product.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Paracetamol + Caffeine Combination (1000/130)</title>
          <description>Two paracetamol (500 mg) and caffeine (65 mg) tablets were dissolved in 200 mL of water and administered orally.</description>
        </group>
        <group group_id="E2">
          <title>Paracetamol (1000)</title>
          <description>Two paracetamol tablets (500 mg each) were dissolved in 200 mL of water and administered orally.</description>
        </group>
        <group group_id="E3">
          <title>Paracetamol + Caffeine Combination (500/65)</title>
          <description>One paracetamol (500 mg) and caffeine (65 mg) tablet was dissolved in 200 mL of water and administered orally.</description>
        </group>
        <group group_id="E4">
          <title>Paracetamol (500)</title>
          <description>One paracetamol tablet (500 mg) was dissolved in 200 mL of water and administered orally.</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="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="75"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>1</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="75"/>
              </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/NCT01686646
org study id: RH01361
nct id: NCT01686646
lead sponsor: 
has dmc: No
This study will investigate any improvement in alertness and performance based on cognitive
      function and mood assessment in subjects suffering the common cold, when taking a novel
      paracetamol and caffeine combination verses paracetamol alone.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change From Baseline in Number of Accurate Responses to Rapid Visual Information Processing (RVIP) Cognitive Test
time frame: Baseline to 60 minutes post treatment administration
description: The RVIP assessed the performance of visual attention mechanisms in remaining vigilant to periodically occurring events. The number of accurate responses to RVIP task was determined from the cognitive function computerised output. Participants monitored a series of single numbers (0-9) appearing in the centre of the screen. During the RVIP task, participants responded to consecutive sequences of three odd or three even numbers by pressing the corresponding response button as quickly and accurately as possible. This was identified in the output file by a value of '1' in 'TARGET=1' column. Also, the response time (in seconds) was recorded in the 'RT' column. If the subject correctly responded to the target, this was identified by a value of '1' in the 'CORRECT=1' column. The number of accurate responses was calculated as the total number of records where 'CORRECT=1' had a value of '1'. The test lasted approximately 9 minutes and number of accurate responses to stimulus was calculated.
measure: Change From Baseline in Number of Accurate Responses to RVIP Cognitive Test
time frame: Baseline to 120 minutes post treatment administration
description: The RVIP assessed the performance of visual attention mechanisms in remaining vigilant to periodically occurring events. The number of accurate responses to RVIP task was determined from the cognitive function computerised output. Participants monitored a series of single numbers (0-9) appearing in the centre of the screen. During the RVIP task, participants responded to consecutive sequences of three odd or three even numbers by pressing the corresponding response button as quickly and accurately as possible. This was identified in the output file by a value of '1' in 'TARGET=1' column. Also, the response time (in seconds) was recorded in the 'RT' column. If the subject correctly responded to the target, this was identified by a value of '1' in the 'CORRECT=1' column. The number of accurate responses was calculated as the total number of records where 'CORRECT=1' had a value of '1'. The test lasted approximately 9 minutes and number of accurate responses to stimulus was calculated.
measure: Change From Baseline in Mean Time of Accurate Responses to RVIP Cognitive Task
time frame: Baseline, 60 minutes and upto 120 minutes post treatment administration
description: The mean time of accurate responses was defined as the mean reaction time for the correct responses. For records with '1' in the 'CORRECT=1' column, the mean time of accurate response was calculated as the summation of the response time values divided by number of records with '1' in the 'CORRECT=1' column. The result was multiplied by 1000 to convert into milliseconds (msecs).
measure: Change From Baseline in Number of Inaccurate and Missed Responses to RVIP Cognitive Task
time frame: Baseline, 60 minutes and up to 120 minutes post treatment administration
description: The no. of inaccurate responses to RVIP was determined from cognitive function computerised output. Participants monitored a series of single numbers (0-9) appearing in the centre of screen. They responded to consecutive sequences of 3 odd or even numbers by pressing the corresponding response button. This was identified in the output file by a value of '1' in the 'TARGET=1' column. If a subject responded incorrectly to stimuli (pressed the response button at the wrong time), this was identified by a value of '-1' in the 'CORRECT=1' column. The no. of incorrect responses was calculated as the total no. of records where 'CORRECT=1' had a value of '-1'. If the subject missed a target (failed to press the response button within 600 msecs of being presented with a string of 3 consecutive even or odd numbers), this was considered a missed response and was calculated as the no. of records where there was a value of '1' in the 'TARGET=1' column and a value of '0' in the 'CORRECT=1' column.
measure: Change From Baseline in Number of Accurate Responses to Sustained Attention Tasks (SAT) Cognitive Test
time frame: Baseline, 60 minutes and up to 120 minutes post treatment administration
description: Auditory and visual attention of participants was evaluated using a validated Sustained Attention task. For the sustained auditory attention task, participants were required to respond whenever they heard the number '8' in a continuous stream of numbers presented through headphones. This was identified in the output file by a value of '8' in the 'NUMBER' column. For the sustained visual attention task, participants were required to respond to the letter 's' every time it appeared in a continuous stream of letters presented on a screen. This was identified in the output file by a value of 's' in the 'LETTER' column. If the subject correctly responded to the target, this was identified by a value of '1' in the 'CORRECT=1' column. The number of accurate responses was calculated as the total number of records where 'CORRECT=1' had a value of '1'.
measure: Change From Baseline in Mean Time of Accurate Responses to SAT Cognitive Task
time frame: Baseline, 30 minutes and up to 60 minutes post treatment administration
description: The mean time of accurate responses was defined as the mean reaction time for the correct responses. For records with '1' in the 'CORRECT=1' column, the mean time of accurate response was calculated as the summation of the response time values divided by number of records with '1' in the 'CORRECT=1' column. The result was multiplied by 1000 to convert into milliseconds (msecs).
measure: Change From Baseline in Number of Incorrect and Missed Responses to SAT Cognitive Test
time frame: Baseline, 60 minutes and up to 120 minutes post treatment administration
description: For sustained auditory attention task, participants were required to respond on hearing the no. '8' in a continuous stream of numbers through headphones. It was identified in output file by a value of '8' in 'NUMBER' column. For sustained visual attention task, participants responded to letter 's' every time it appeared in a continuous stream of letters presented on screen. This was identified in output file by a value of 's' in 'LETTER' column. If a subject responded incorrectly (pressed the response button at the wrong time), it was identified by a value of '-1' in 'CORRECT=1' column. The no. of incorrect responses was calculated as total no. of records where 'CORRECT=1' had a value of '-1'. The no. of missed responses (when subject failed to press the response button on hearing the number '8' or seeing the letter 's'), was calculated as the no. of records where there was a value of '8' in 'NUMBER' column or 's' in the 'LETTER' column and a value of '0' in the 'CORRECT=1' column.
measure: Change From Baseline in Number of Valid Responses to Divided Attention Task (DAT) Cognitive Test
time frame: Baseline, 60 minutes and up to 120 minutes post treatment administration
description: Auditory and visual attention of participants was evaluated using a validated Divided Attention task. Participants were required to respond whenever they heard the number '8' in a continuous stream of numbers presented through headphones or saw a letter 's' on the screen . This was identified in the output file by a value of '8' in the 'NUMBER' column or by a value of 's' in the 'LETTER' column. If the subject correctly responded to the target, this was identified by a value of '1' in the 'CORRECT=1' column. The number of accurate responses was calculated as the total number of records where 'CORRECT=1' had a value of '1'.
measure: Change From Baseline in Mean Time of Accurate Responses to DAT Cognitive Test
time frame: Baseline, 60 minutes and up to 120 minutes post treatment administration
description: The mean time of accurate responses was defined as the mean reaction time for the correct responses. For records with '1' in the 'CORRECT=1' column, the mean time of accurate response was calculated as the summation of the response time values divided by number of records with '1' in the 'CORRECT=1' column. The result was multiplied by 1000 to convert into milliseconds (msecs).
measure: Change From Baseline in Number of Incorrect and Missed Responses to DAT Cognitive Test
time frame: Baseline, 60 minutes and up to 120 minutes post treatment administration
description: For the Divided Attention task, participants were required to respond on hearing the no. '8' in a continuous stream of numbers through headphones or seeing a letter 's' on screen. This was identified in the output file by a value of '8' in 'NUMBER' column or 's' in 'LETTER' column. If a subject responded incorrectly (pressed the response button at the wrong time), this was identified by a value of '-1' in 'CORRECT=1' column. The number of incorrect responses was calculated as the total no. of records where 'CORRECT=1' had a value of '-1'. If the subject missed a target (failed to press the response button on hearing the no. '8' or seeing the letter 's'), this was considered a missed response. The number of missed responses was calculated as the no. of records where there was a value of '8' in 'NUMBER' column or 's' in 'LETTER' column and a value of '0' in the 'CORRECT=1' column.
arm group label: highest dose Paracetamol + caffeine
arm group type: Active Comparator
description: highest dose of Paracetamol and caffeine
arm group label: low-dose Paracetamol + caffeine
arm group type: Active Comparator
description: lowest dose of Paracetamol and caffeine
arm group label: high dose paracetamol
arm group type: Active Comparator
description: highest dose paracetamol
arm group label: low dose paracetamol
arm group type: Active Comparator
description: lowest dose paracetamol
intervention type: Drug
intervention name: paracetamol + caffeine
description: paracetamol with caffeine
arm group label: highest dose Paracetamol + caffeine
arm group label: low-dose Paracetamol + caffeine
intervention type: Drug
intervention name: paracetamol
description: paracetamol
arm group label: high dose paracetamol
arm group label: low dose paracetamol
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: GSK Clinical Trials
role: Study Director
affiliation: GlaxoSmithKline
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Common Cold
mesh term: Acetaminophen
mesh term: Caffeine
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 