Last updated: 11/04/2018 10:25:43

Effects of two doses of a common cold treatment on alertness

GSK study ID
RH01361
See study documents
Clinicaltrials.gov ID
NCT01686646
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 two doses of a common cold treatment on cognitive function
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

Change from baseline in number of accurate responses to Rapid Visual Information Processing (RVIP) Cognitive test

Timeframe: Baseline to 60 minutes post treatment administration

Secondary outcomes:

Change from baseline in number of accurate responses to RVIP Cognitive test

Timeframe: Baseline to 120 minutes post treatment administration

Change from baseline in mean time of accurate responses to RVIP Cognitive Task

Timeframe: Baseline, 60 minutes and upto 120 minutes post treatment administration

Change from baseline in number of inaccurate and missed responses to RVIP Cognitive Task

Timeframe: Baseline, 60 minutes and up to 120 minutes post treatment administration

Change from baseline in number of accurate responses to Sustained Attention Tasks (SAT) Cognitive test

Timeframe: Baseline, 60 minutes and up to 120 minutes post treatment administration

Change from baseline in mean time of accurate responses to SAT Cognitive Task

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

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

Timeframe: Baseline, 60 minutes and up to 120 minutes post treatment administration

Change from baseline in number of valid responses to Divided Attention Task (DAT) Cognitive test

Timeframe: Baseline, 60 minutes and up to 120 minutes post treatment administration

Change from baseline in mean time of accurate responses to DAT Cognitive test

Timeframe: Baseline, 60 minutes and up to 120 minutes post treatment administration

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

Timeframe: Baseline, 60 minutes and up to 120 minutes post treatment administration

Interventions:
  • Drug: paracetamol + caffeine
  • Drug: paracetamol
    • Enrollment:
    240
    Primary completion date:
    2012-30-11
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Common cold
    Product
    caffeine, paracetamol
    Collaborators
    Not applicable
    Study date(s)
    November 2011 to November 2012
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • Participants with symptoms of cold < 96 hours, rating of at least '2' on malaise at least 4 other symptoms of cold.
    • No history of clinically significant perennial rhinitis, no recent antibiotic, antihistamine or cold treatment, no caffeine in the previous 12 hours, no psychoactive medication in the 14 days prior to screening, no pregnancy, breastfeeding or participation in this trial, or another trial in the 30 days prior to screening.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Participants with symptoms of cold < 96 hours, rating of at least '2' on malaise at least 4 other symptoms of cold.
    • No history of clinically significant perennial rhinitis, no recent antibiotic, antihistamine or cold treatment, no caffeine in the previous 12 hours, no psychoactive medication in the 14 days prior to screening, no pregnancy, breastfeeding or participation in this trial, or another trial in the 30 days prior to screening.

    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
    2012-30-11
    Actual study completion date
    2012-30-11

    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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