Clinical trial NCT01466348: Effects of a Common Cold Treatment on Cognitive Function
Official title: Effects of a Common Cold Treatment on Cognitive Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Common Cold
Keywords: Paracetomol
Caffeine
Common cold
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-11-06
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: 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:
measure: Adjusted Mean Change From Baseline in Number of Valid Responses to RVIP Cognitive Test
timeFrame: Baseline to 60 minutes post treatment administration
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
Other outcomes:
Locations:
city: Cardiff
country: United Kingdom
facility: Common Cold Centre
state: Wales
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: