Clinical Trial: Effects of Two Doses of a Common Cold Treatment on Alertness

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Effects of Two Doses of a Common Cold Treatment on Cognitive Function

Brief Summary: 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.

Detailed Summary:
Sponsor: GlaxoSmithKline

Current Primary Outcome: 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 ]

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.


Original Primary Outcome: Number of correct responses to Rapid Visual Information Processing (RVIP) [ Time Frame: 60 minutes post dose ]

assess the change in alertness level in people suffering from the common cold following paracetamol and caffeine compared to paracetamol alone


Current Secondary Outcome:

  • Change From Baseline in Number of Accurate Responses to RVIP Cognitive Test [ Time Frame: Baseline to 120 minutes post treatment administration ]
    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.
  • 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 ]
    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).
  • 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 ]
    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.
  • 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 ]
    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'.
  • 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 ]
    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).
  • 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 ]
    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 a

    Original Secondary Outcome:

    • mean time of accurate responses on the RVIP [ Time Frame: 120 minutes post dose ]
      assess the change in alertness level in people suffering from the common cold, following paracetamol and caffeine compared to paracetamol
    • Number of correct responses to sustained and divided attention task [ Time Frame: 120 minutes post dose ]
      assess the change in alertness level using the number of accurate responses to the task, and the mean time of accurate response
    • Number of correct responses to RVIP [ Time Frame: 120 minutes post dose ]
      assess the change in alertness level in people suffering from the common cold, following paracetamol and caffeine compared to paracetamol


    Information By: GlaxoSmithKline

    Dates:
    Date Received: September 13, 2012
    Date Started: November 2011
    Date Completion:
    Last Updated: November 20, 2014
    Last Verified: July 2014