Effects of a Common Cold Treatment on Cognitive Function

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01466348
First received: November 3, 2011
Last updated: September 25, 2013
Last verified: September 2013

November 3, 2011
September 25, 2013
February 2011
April 2011   (final data collection date for primary outcome measure)
Adjusted Mean Change From Baseline in Number of Valid Responses to Rapid Visual Information Processing (RVIP) Cognitive Test [ Time Frame: Baseline to 30 minutes post treatment administration ] [ Designated as safety issue: No ]
The RVIP assessed the performance of visual attention mechanisms in remaining vigilant to periodically occurring events. 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. The test lasted approximately 9 minutes and mean number of valid responses to stimulus was calculated.
Change from baseline in valid responses to Rapid Visual Information Processing (RVIP) [ Time Frame: 30 minutes post dose ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01466348 on ClinicalTrials.gov Archive Site
  • Adjusted Mean Change From Baseline in Number of Valid Responses to RVIP Cognitive Test [ Time Frame: Baseline to 60 minutes post treatment administration ] [ Designated as safety issue: No ]
    The RVIP assessed the performance of visual attention mechanisms in remaining vigilant to periodically occurring events. 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. The test lasted approximately 9 minutes and mean number of valid responses to stimulus was calculated.
  • Adjusted Mean Change in Baseline in Valid Reaction Time to RVIP Cognitive Test [ Time Frame: Baseline, 30 minutes and up to 60 minutes post treatment administration ] [ Designated as safety issue: No ]
    The RVIP assessed the performance of visual attention mechanisms in remaining vigilant to periodically occurring events. 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. Mean valid reaction time was determined.
  • Mean Change From Baseline in Number of Incorrect and Missed Responses to RVIP Cognitive Test [ Time Frame: Baseline, 30 minutes and up to 60 minutes post treatment administration ] [ Designated as safety issue: No ]
    The RVIP assessed the performance of visual attention mechanisms in remaining vigilant to periodically occurring events. 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. The test lasted approximately 9 minutes and mean number of valid responses to stimulus was calculated.
  • Adjusted Mean Change From Baseline in Number of Valid Responses to Sustained Attention Tasks (SAT) Cognitive Test [ Time Frame: Baseline, 30 minutes and up to 60 minutes post treatment administration ] [ Designated as safety issue: No ]
    Auditory and visual attention of participants was evaluated using a validated Sustained Attention task. For the sustained visual attention task, participants were required to respond to the letter 's' every time it appears in a continuous stream of letters presented on a screen. For the sustained auditory attention task, participants responded to the number '8' every time it appears in a continuous stream of numbers presented through headphones. Total test duration was approximately 6 minutes. Mean values of valid responses to visual and auditory tests were calculated.
  • Mean Change From Baseline in Number of Incorrect and Missed Responses to SAT Cognitive Test [ Time Frame: Baseline, 30 minutes and up to 60 minutes post treatment administration ] [ Designated as safety issue: No ]
    Auditory and visual attention of participants was evaluated using a validated Sustained Attention task. For the sustained visual attention task, participants were required to respond to the letter 's' every time it appears in a continuous stream of letters presented on a screen. For the sustained auditory attention task, participants responded to the number '8' every time it appears in a continuous stream of numbers presented through headphones. Total test duration was approximately 6 minutes. Mean values of incorrect and missed responses to visual and auditory tests were calculated.
  • Adjusted Mean Change From Baseline in Valid Reaction Time to SAT Cognitive Test [ Time Frame: Baseline, 30 minutes and up to 60 minutes post treatment administration ] [ Designated as safety issue: No ]
    Auditory and visual attention of participants was evaluated using a validated Sustained Attention task. For the sustained visual attention task, participants were required to respond to the letter 's' every time it appears in a continuous stream of letters presented on a screen. For the sustained auditory attention task, participants responded to the number '8' every time it appears in a continuous stream of numbers presented through headphones. Total test duration was approximately 6 minutes. Mean values of valid reaction time to visual and auditory tests were calculated.
  • Adjusted Mean Change From Baseline in Number of Valid Responses to Divided Attention Task (DAT) Cognitive Test [ Time Frame: Baseline, 30 minutes and up to 60 minutes post treatment administration ] [ Designated as safety issue: No ]
    For the DAT Cognitive test, auditory and visual stimuli were simultaneously presented and participants were asked to respond to occurrences of 's' (visual) or '8' (auditory). Total test duration was approximately 6 minutes. Mean values of valid responses to visual and auditory tests were calculated.
  • Adjusted Mean Change From Baseline in Valid Reaction Time to DAT Cognitive Test [ Time Frame: Baseline, 30 minutes and up to 60 minutes post treatment administration ] [ Designated as safety issue: No ]
    For the DAT Cognitive test, auditory and visual stimuli were simultaneously presented and participants were asked to respond to occurrences of 's' (visual) or '8' (auditory). Total test duration was approximately 6 minutes. Mean values of valid reaction time to visual and auditory tests were calculated.
  • Mean Change From Baseline in Number of Incorrect and Missed Responses to DAT Cognitive Test [ Time Frame: Baseline, 30 minutes and up to 60 minutes post treatment administration ] [ Designated as safety issue: No ]
    For the DAT Cognitive test, auditory and visual stimuli were simultaneously presented and participants were asked to respond to occurrences of 's' (visual) or '8' (auditory). Total test duration was approximately 6 minutes. Mean values of incorrect and missed responses to visual and auditory tests were calculated.
  • Adjusted Mean Change From Baseline in Mood Alertness and Physical Sensation Scales (MAPSS) Cognitive Test [ Time Frame: Baseline, 30 minutes and up to 60 minutes post treatment administration ] [ Designated as safety issue: No ]
    Mood patterns was evaluated using the Mood, Alertness and Physical Sensation Scales (MAPSS) which comprised of 23 questions describing moods and physical sensations, on a 9-point scale anchored at the left hand end with 'not at all' and the right hand end with 'extremely'. For each question, '9' represented the 'best' score and '1' represented the 'worst' score. Mean score was calculated by summing the responses and dividing by the number of questions answered. MAPSS Questionnaire was further divided into three main clusters: Alertness; Anxiety and Headache as per the questions.
  • Change from baseline in valid responses to RVIP [ Time Frame: up to 60 minutes post dose ] [ Designated as safety issue: No ]
  • Change from baseline Mood Alertness and Physical Sensation Scales (MAPSS) [ Time Frame: up to 60 minutes post dose ] [ Designated as safety issue: No ]
  • Change from baseline in valid responses to sustained and divided attention task score [ Time Frame: up to 60 minutes post dose ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Effects of a Common Cold Treatment on Cognitive Function
Effects of a Common Cold Treatment on Cognitive Function

A reduction in alertness and lower levels of performance are commonly associated with the common cold. Paracetamol has been shown to be more effective than placebo in treating symptoms associated with upper respiratory tract infection; caffeine has been shown to increase levels of alertness and improve performance of people suffering from colds. This study will investigate any improvement in alertness and performance based on cognitive function and mood assessment in subjects suffering from the common cold, when taking a novel paracetamol and caffeine combination verses paracetamol alone.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Common Cold
  • Drug: Paracetamol and Caffeine
    Paracetamol 1000 mg and caffeine 130 mg
  • Drug: Paracetamol
    Paracetamol 1000 mg
  • Experimental: Paracetamol and Caffeine
    Paracetamol and caffeine
    Intervention: Drug: Paracetamol and Caffeine
  • Active Comparator: Paracetamol
    Paracetamol
    Intervention: Drug: Paracetamol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
72
April 2011
April 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Present with symptoms of the common cold of no more than 96 hours duration
  • Score of "2" or more on a self-rating for malaise and at least 4 other cold symptoms

Exclusion Criteria:

  • Pregnancy or lactation
  • Hypersensitivity to drugs
  • Have taken caffeine in the last 12 hours or treated their cold
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01466348
C6930943
No
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP