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
Completed
Completed
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
Observational study model:
Not applicable
Primary completion date:
2011-30-04
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
Completed
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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