Phase 4
N=72
Effects of a Common Cold Treatment on Cognitive Function
Common Cold
Bottom Line
View on ClinicalTrials.gov: NCT01466348 ↗Enrolled (actual)
72
Serious AEs
0.0%
Results posted
Nov 2013
Primary outcome: Primary: Adjusted Mean Change From Baseline in Number of Valid Responses to Rapid Visual Information Processing (RVIP) Cognitive Test — 4.8; 1.3 Valid responses — p=0.0008
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Paracetamol and Caffeine (Drug); Paracetamol (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Apr 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adjusted Mean Change From Baseline in Number of Valid Responses to Rapid Visual Information Processing (RVIP) Cognitive Test |
4.8; 1.3 | 0.0008 sig |
| SECONDARY Adjusted Mean Change From Baseline in Number of Valid Responses to RVIP Cognitive Test |
7.1; 0.6 | <0.0001 sig |
| SECONDARY Adjusted Mean Change in Baseline in Valid Reaction Time to RVIP Cognitive Test |
6.00; 1.88; 0.08; -4.85 | — |
| SECONDARY Mean Change From Baseline in Number of Incorrect and Missed Responses to RVIP Cognitive Test |
-2.3; -2.7; -1.7; -2.7; -4.8; -1.3 | — |
| SECONDARY Adjusted Mean Change From Baseline in Number of Valid Responses to Sustained Attention Tasks (SAT) Cognitive Test |
1.8; -0.5; 1.5; -0.7 | — |
| SECONDARY Mean Change From Baseline in Number of Incorrect and Missed Responses to SAT Cognitive Test |
-2.3; 0.1; -3.6; 0.6; -1.8; 0.5 | — |
| SECONDARY Adjusted Mean Change From Baseline in Valid Reaction Time to SAT Cognitive Test |
-6.49; -6.18; -10.69; -9.45 | — |
| SECONDARY Adjusted Mean Change From Baseline in Number of Valid Responses to Divided Attention Task (DAT) Cognitive Test |
6.8; 2.0; 7.4; 1.9 | — |
| SECONDARY Adjusted Mean Change From Baseline in Valid Reaction Time to DAT Cognitive Test |
1.65; -7.42; -5.49; -12.39 | — |
| SECONDARY Mean Change From Baseline in Number of Incorrect and Missed Responses to DAT Cognitive Test |
-5.4; -1.4; -5.2; -0.2; -6.7; -2.0 | — |
| SECONDARY Adjusted Mean Change From Baseline in Mood Alertness and Physical Sensation Scales (MAPSS) Cognitive Test |
0.8; 0.2; 0.7; 0.1; 0.2; 0.2 | — |
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
Data sourced from ClinicalTrials.gov (NCT01466348). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.