Clinical trial NCT01686646: Effects of Two Doses of a Common Cold Treatment on Alertness
Official title: Effects of Two Doses of a Common Cold Treatment on Cognitive Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Common Cold
Keywords: alertness
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2012-09-18
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: 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:
measure: Change From Baseline in Number of Accurate Responses to RVIP Cognitive Test
timeFrame: Baseline to 120 minutes post treatment administration
measure: Change From Baseline in Mean Time of Accurate Responses to RVIP Cognitive Task
timeFrame: Baseline, 60 minutes and upto 120 minutes post treatment administration
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
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: