Last updated: 11/04/2018 05:47:49

Effects of a common cold treatment on cognitive function

GSK study ID
C6930943
See study documents
Clinicaltrials.gov ID
NCT01466348
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Effects of a common cold treatment on cognitive function
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Single (Investigator)
Allocation:
Randomized
Primary outcomes:

Adjusted mean change from baseline in number of valid responses to Rapid Visual Information Processing (RVIP) Cognitive test

Timeframe: Baseline to 30 minutes post treatment administration

Secondary outcomes:

Adjusted mean change from baseline in number of valid responses to RVIP Cognitive test

Timeframe: Baseline to 60 minutes post treatment administration

Adjusted mean change in baseline in valid reaction time to RVIP Cognitive test

Timeframe: Baseline, 30 minutes and up to 60 minutes post treatment administration

Mean change from baseline in number of incorrect and missed responses to RVIP Cognitive test

Timeframe: Baseline, 30 minutes and up to 60 minutes post treatment administration

Adjusted mean change from baseline in number of valid responses to Sustained Attention Tasks (SAT) Cognitive test

Timeframe: Baseline, 30 minutes and up to 60 minutes post treatment administration

Mean change from baseline in number of incorrect and missed responses to SAT Cognitive test

Timeframe: Baseline, 30 minutes and up to 60 minutes post treatment administration

Adjusted mean change from baseline in valid reaction time to SAT Cognitive test

Timeframe: Baseline, 30 minutes and up to 60 minutes post treatment administration

Adjusted mean change from baseline in number of valid responses to divided attention task (DAT) Cognitive test

Timeframe: Baseline, 30 minutes and up to 60 minutes post treatment administration

Adjusted mean change from baseline in valid reaction time to DAT Cognitive test

Timeframe: Baseline, 30 minutes and up to 60 minutes post treatment administration

Mean change from baseline in number of incorrect and missed responses to DAT Cognitive test

Timeframe: Baseline, 30 minutes and up to 60 minutes post treatment administration

Adjusted mean change from baseline in Mood Alertness and Physical Sensation Scales (MAPSS) Cognitive test

Timeframe: Baseline, 30 minutes and up to 60 minutes post treatment administration

Interventions:
  • Drug: Paracetamol and Caffeine
  • Drug: Paracetamol
    • Enrollment:
    72
    Primary completion date:
    2011-30-04
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Common cold
    Product
    paracetamol
    Collaborators
    Not applicable
    Study date(s)
    February 2011 to April 2011
    Type
    Interventional
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • 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
    • Pregnancy or lactation
    • Hypersensitivity to drugs
    Inclusion and exclusion criteria
    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

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    Common Cold Centre
    Cardiff, Wales, United Kingdom, Not Available
    Status
    Study Complete
    Contact us

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2011-30-04
    Actual study completion date
    2011-30-04

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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