Common Cold
Conditions
Keywords
Paracetomol, Caffeine, Common cold
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.
Interventions
Paracetamol 1000 mg and caffeine 130 mg
DRUGParacetamol
Paracetamol 1000 mg
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adjusted Mean Change From Baseline in Number of Valid Responses to Rapid Visual Information Processing (RVIP) Cognitive Test | Baseline to 30 minutes post treatment administration | The RVIP assessed the performance of visual attention mechanisms in remaining vigilant to periodically occurring events. Participants monitored a series of single numbers (0-9) appearing in the centre of the screen. During the RVIP task, participants responded to consecutive sequences of three odd or three even numbers by pressing the corresponding response button as quickly and accurately as possible. The test lasted approximately 9 minutes and mean number of valid responses to stimulus was calculated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adjusted Mean Change in Baseline in Valid Reaction Time to RVIP Cognitive Test | Baseline, 30 minutes and up to 60 minutes post treatment administration | The RVIP assessed the performance of visual attention mechanisms in remaining vigilant to periodically occurring events. Participants monitored a series of single numbers (0-9) appearing in the centre of the screen. During the RVIP task, participants responded to consecutive sequences of three odd or three even numbers by pressing the corresponding response button as quickly and accurately as possible. Mean valid reaction time was determined. |
| Mean Change From Baseline in Number of Incorrect and Missed Responses to RVIP Cognitive Test | Baseline, 30 minutes and up to 60 minutes post treatment administration | The RVIP assessed the performance of visual attention mechanisms in remaining vigilant to periodically occurring events. Participants monitored a series of single numbers (0-9) appearing in the centre of the screen. During the RVIP task, participants responded to consecutive sequences of three odd or three even numbers by pressing the corresponding response button as quickly and accurately as possible. The test lasted approximately 9 minutes and mean number of valid responses to stimulus was calculated. |
| Adjusted Mean Change From Baseline in Number of Valid Responses to Sustained Attention Tasks (SAT) Cognitive Test | Baseline, 30 minutes and up to 60 minutes post treatment administration | Auditory and visual attention of participants was evaluated using a validated Sustained Attention task. For the sustained visual attention task, participants were required to respond to the letter 's' every time it appears in a continuous stream of letters presented on a screen. For the sustained auditory attention task, participants responded to the number '8' every time it appears in a continuous stream of numbers presented through headphones. Total test duration was approximately 6 minutes. Mean values of valid responses to visual and auditory tests were calculated. |
| Mean Change From Baseline in Number of Incorrect and Missed Responses to SAT Cognitive Test | Baseline, 30 minutes and up to 60 minutes post treatment administration | Auditory and visual attention of participants was evaluated using a validated Sustained Attention task. For the sustained visual attention task, participants were required to respond to the letter 's' every time it appears in a continuous stream of letters presented on a screen. For the sustained auditory attention task, participants responded to the number '8' every time it appears in a continuous stream of numbers presented through headphones. Total test duration was approximately 6 minutes. Mean values of incorrect and missed responses to visual and auditory tests were calculated. |
| Adjusted Mean Change From Baseline in Number of Valid Responses to RVIP Cognitive Test | Baseline to 60 minutes post treatment administration | The RVIP assessed the performance of visual attention mechanisms in remaining vigilant to periodically occurring events. Participants monitored a series of single numbers (0-9) appearing in the centre of the screen. During the RVIP task, participants responded to consecutive sequences of three odd or three even numbers by pressing the corresponding response button as quickly and accurately as possible. The test lasted approximately 9 minutes and mean number of valid responses to stimulus was calculated. |
| Adjusted Mean Change From Baseline in Number of Valid Responses to Divided Attention Task (DAT) Cognitive Test | Baseline, 30 minutes and up to 60 minutes post treatment administration | For the DAT Cognitive test, auditory and visual stimuli were simultaneously presented and participants were asked to respond to occurrences of 's' (visual) or '8' (auditory). Total test duration was approximately 6 minutes. Mean values of valid responses to visual and auditory tests were calculated. |
| Adjusted Mean Change From Baseline in Valid Reaction Time to DAT Cognitive Test | Baseline, 30 minutes and up to 60 minutes post treatment administration | For the DAT Cognitive test, auditory and visual stimuli were simultaneously presented and participants were asked to respond to occurrences of 's' (visual) or '8' (auditory). Total test duration was approximately 6 minutes. Mean values of valid reaction time to visual and auditory tests were calculated. |
| Mean Change From Baseline in Number of Incorrect and Missed Responses to DAT Cognitive Test | Baseline, 30 minutes and up to 60 minutes post treatment administration | For the DAT Cognitive test, auditory and visual stimuli were simultaneously presented and participants were asked to respond to occurrences of 's' (visual) or '8' (auditory). Total test duration was approximately 6 minutes. Mean values of incorrect and missed responses to visual and auditory tests were calculated. |
| Adjusted Mean Change From Baseline in Mood Alertness and Physical Sensation Scales (MAPSS) Cognitive Test | Baseline, 30 minutes and up to 60 minutes post treatment administration | Mood patterns was evaluated using the Mood, Alertness and Physical Sensation Scales (MAPSS) which comprised of 23 questions describing moods and physical sensations, on a 9-point scale anchored at the left hand end with 'not at all' and the right hand end with 'extremely'. For each question, '9' represented the 'best' score and '1' represented the 'worst' score. Mean score was calculated by summing the responses and dividing by the number of questions answered. MAPSS Questionnaire was further divided into three main clusters: Alertness; Anxiety and Headache as per the questions. |
| Adjusted Mean Change From Baseline in Valid Reaction Time to SAT Cognitive Test | Baseline, 30 minutes and up to 60 minutes post treatment administration | Auditory and visual attention of participants was evaluated using a validated Sustained Attention task. For the sustained visual attention task, participants were required to respond to the letter 's' every time it appears in a continuous stream of letters presented on a screen. For the sustained auditory attention task, participants responded to the number '8' every time it appears in a continuous stream of numbers presented through headphones. Total test duration was approximately 6 minutes. Mean values of valid reaction time to visual and auditory tests were calculated. |
Countries
United Kingdom
Participant flow
Recruitment details
Participants were recruited at the clinical site.
Pre-assignment details
A total of 75 participants were screened, and 72 were randomized. 3 participants did not meet the study criterion. A 5 hour washout period was maintained between treatment periods.
Participants by arm
| Arm | Count |
|---|---|
| All Randomized Participants All randomized participants were evaluated for baseline measures. | 71 |
| Total | 71 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period I - First Intervention | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | All Randomized Participants |
|---|---|
| Age Continuous | 20.8 Years STANDARD_DEVIATION 4.19 |
| Sex: Female, Male Female | 47 Participants |
| Sex: Female, Male Male | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 71 | 0 / 71 |
| serious Total, serious adverse events | 0 / 71 | 0 / 71 |
Outcome results
Primary
Adjusted Mean Change From Baseline in Number of Valid Responses to Rapid Visual Information Processing (RVIP) Cognitive Test
The RVIP assessed the performance of visual attention mechanisms in remaining vigilant to periodically occurring events. Participants monitored a series of single numbers (0-9) appearing in the centre of the screen. During the RVIP task, participants responded to consecutive sequences of three odd or three even numbers by pressing the corresponding response button as quickly and accurately as possible. The test lasted approximately 9 minutes and mean number of valid responses to stimulus was calculated.
Time frame: Baseline to 30 minutes post treatment administration
Population: Intent-To-Treat (ITT) population: All randomized participants who were randomized and had at least one post-baseline efficacy evaluation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paracetamol/ Caffeine Tablet | Adjusted Mean Change From Baseline in Number of Valid Responses to Rapid Visual Information Processing (RVIP) Cognitive Test | 4.8 Valid responses | Standard Deviation 0.8 |
| Paracetamol Powder | Adjusted Mean Change From Baseline in Number of Valid Responses to Rapid Visual Information Processing (RVIP) Cognitive Test | 1.3 Valid responses | Standard Deviation 0.8 |
Comparison: Null hypothesis was no difference in treatments in the change from baseline in the number of valid responses from the RVIP.p-value: 0.000895% CI: [1.5, 5.6]ANOVA
Secondary
Adjusted Mean Change From Baseline in Mood Alertness and Physical Sensation Scales (MAPSS) Cognitive Test
Mood patterns was evaluated using the Mood, Alertness and Physical Sensation Scales (MAPSS) which comprised of 23 questions describing moods and physical sensations, on a 9-point scale anchored at the left hand end with 'not at all' and the right hand end with 'extremely'. For each question, '9' represented the 'best' score and '1' represented the 'worst' score. Mean score was calculated by summing the responses and dividing by the number of questions answered. MAPSS Questionnaire was further divided into three main clusters: Alertness; Anxiety and Headache as per the questions.
Time frame: Baseline, 30 minutes and up to 60 minutes post treatment administration
Population: ITT population: All randomized participants who were randomized and had at least one post-baseline efficacy evaluation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Paracetamol/ Caffeine Tablet | Adjusted Mean Change From Baseline in Mood Alertness and Physical Sensation Scales (MAPSS) Cognitive Test | Alertness at 30 minutes | 0.8 Score on a scale | Standard Error 0.12 |
| Paracetamol/ Caffeine Tablet | Adjusted Mean Change From Baseline in Mood Alertness and Physical Sensation Scales (MAPSS) Cognitive Test | Alertness at 60 minutes | 0.7 Score on a scale | Standard Error 0.13 |
| Paracetamol/ Caffeine Tablet | Adjusted Mean Change From Baseline in Mood Alertness and Physical Sensation Scales (MAPSS) Cognitive Test | Anxiety at 30 minutes | 0.2 Score on a scale | Standard Error 0.08 |
| Paracetamol/ Caffeine Tablet | Adjusted Mean Change From Baseline in Mood Alertness and Physical Sensation Scales (MAPSS) Cognitive Test | Anxiety at 60 minutes | 0.3 Score on a scale | Standard Error 0.08 |
| Paracetamol/ Caffeine Tablet | Adjusted Mean Change From Baseline in Mood Alertness and Physical Sensation Scales (MAPSS) Cognitive Test | Headache at 30 minutes | 0.4 Score on a scale | Standard Error 0.1 |
| Paracetamol/ Caffeine Tablet | Adjusted Mean Change From Baseline in Mood Alertness and Physical Sensation Scales (MAPSS) Cognitive Test | Headache at 60 minutes | 0.6 Score on a scale | Standard Error 0.1 |
| Paracetamol Powder | Adjusted Mean Change From Baseline in Mood Alertness and Physical Sensation Scales (MAPSS) Cognitive Test | Headache at 30 minutes | 0.4 Score on a scale | Standard Error 0.1 |
| Paracetamol Powder | Adjusted Mean Change From Baseline in Mood Alertness and Physical Sensation Scales (MAPSS) Cognitive Test | Alertness at 30 minutes | 0.2 Score on a scale | Standard Error 0.12 |
| Paracetamol Powder | Adjusted Mean Change From Baseline in Mood Alertness and Physical Sensation Scales (MAPSS) Cognitive Test | Anxiety at 60 minutes | 0.4 Score on a scale | Standard Error 0.08 |
| Paracetamol Powder | Adjusted Mean Change From Baseline in Mood Alertness and Physical Sensation Scales (MAPSS) Cognitive Test | Alertness at 60 minutes | 0.1 Score on a scale | Standard Error 0.13 |
| Paracetamol Powder | Adjusted Mean Change From Baseline in Mood Alertness and Physical Sensation Scales (MAPSS) Cognitive Test | Headache at 60 minutes | 0.6 Score on a scale | Standard Error 0.1 |
| Paracetamol Powder | Adjusted Mean Change From Baseline in Mood Alertness and Physical Sensation Scales (MAPSS) Cognitive Test | Anxiety at 30 minutes | 0.2 Score on a scale | Standard Error 0.08 |
Secondary
Adjusted Mean Change From Baseline in Number of Valid Responses to Divided Attention Task (DAT) Cognitive Test
For the DAT Cognitive test, auditory and visual stimuli were simultaneously presented and participants were asked to respond to occurrences of 's' (visual) or '8' (auditory). Total test duration was approximately 6 minutes. Mean values of valid responses to visual and auditory tests were calculated.
Time frame: Baseline, 30 minutes and up to 60 minutes post treatment administration
Population: ITT population: All randomized participants who were randomized and had at least one post-baseline efficacy evaluation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Paracetamol/ Caffeine Tablet | Adjusted Mean Change From Baseline in Number of Valid Responses to Divided Attention Task (DAT) Cognitive Test | 30 minutes | 6.8 Valid responses | Standard Error 1 |
| Paracetamol/ Caffeine Tablet | Adjusted Mean Change From Baseline in Number of Valid Responses to Divided Attention Task (DAT) Cognitive Test | 60 minutes | 7.4 Valid responses | Standard Error 1.01 |
| Paracetamol Powder | Adjusted Mean Change From Baseline in Number of Valid Responses to Divided Attention Task (DAT) Cognitive Test | 30 minutes | 2.0 Valid responses | Standard Error 0.99 |
| Paracetamol Powder | Adjusted Mean Change From Baseline in Number of Valid Responses to Divided Attention Task (DAT) Cognitive Test | 60 minutes | 1.9 Valid responses | Standard Error 1 |
Secondary
Adjusted Mean Change From Baseline in Number of Valid Responses to RVIP Cognitive Test
The RVIP assessed the performance of visual attention mechanisms in remaining vigilant to periodically occurring events. Participants monitored a series of single numbers (0-9) appearing in the centre of the screen. During the RVIP task, participants responded to consecutive sequences of three odd or three even numbers by pressing the corresponding response button as quickly and accurately as possible. The test lasted approximately 9 minutes and mean number of valid responses to stimulus was calculated.
Time frame: Baseline to 60 minutes post treatment administration
Population: ITT population: All randomized participants who were randomized and had at least one post-baseline efficacy evaluation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paracetamol/ Caffeine Tablet | Adjusted Mean Change From Baseline in Number of Valid Responses to RVIP Cognitive Test | 7.1 Valid responses | Standard Deviation 0.93 |
| Paracetamol Powder | Adjusted Mean Change From Baseline in Number of Valid Responses to RVIP Cognitive Test | 0.6 Valid responses | Standard Deviation 0.93 |
Comparison: Null hypothesis was no difference in treatments in the change from baseline in the number of valid responses from the RVIP.p-value: <0.000195% CI: [4.5, 8.4]ANOVA
Secondary
Adjusted Mean Change From Baseline in Number of Valid Responses to Sustained Attention Tasks (SAT) Cognitive Test
Auditory and visual attention of participants was evaluated using a validated Sustained Attention task. For the sustained visual attention task, participants were required to respond to the letter 's' every time it appears in a continuous stream of letters presented on a screen. For the sustained auditory attention task, participants responded to the number '8' every time it appears in a continuous stream of numbers presented through headphones. Total test duration was approximately 6 minutes. Mean values of valid responses to visual and auditory tests were calculated.
Time frame: Baseline, 30 minutes and up to 60 minutes post treatment administration
Population: ITT population: All randomized participants who were randomized and had at least one post-baseline efficacy evaluation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Paracetamol/ Caffeine Tablet | Adjusted Mean Change From Baseline in Number of Valid Responses to Sustained Attention Tasks (SAT) Cognitive Test | 30 minutes | 1.8 Valid responses | Standard Error 0.52 |
| Paracetamol/ Caffeine Tablet | Adjusted Mean Change From Baseline in Number of Valid Responses to Sustained Attention Tasks (SAT) Cognitive Test | 60 minutes | 1.5 Valid responses | Standard Error 0.55 |
| Paracetamol Powder | Adjusted Mean Change From Baseline in Number of Valid Responses to Sustained Attention Tasks (SAT) Cognitive Test | 60 minutes | -0.7 Valid responses | Standard Error 0.55 |
| Paracetamol Powder | Adjusted Mean Change From Baseline in Number of Valid Responses to Sustained Attention Tasks (SAT) Cognitive Test | 30 minutes | -0.5 Valid responses | Standard Error 0.51 |
Secondary
Adjusted Mean Change From Baseline in Valid Reaction Time to DAT Cognitive Test
For the DAT Cognitive test, auditory and visual stimuli were simultaneously presented and participants were asked to respond to occurrences of 's' (visual) or '8' (auditory). Total test duration was approximately 6 minutes. Mean values of valid reaction time to visual and auditory tests were calculated.
Time frame: Baseline, 30 minutes and up to 60 minutes post treatment administration
Population: ITT population: All randomized participants who were randomized and had at least one post-baseline efficacy evaluation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Paracetamol/ Caffeine Tablet | Adjusted Mean Change From Baseline in Valid Reaction Time to DAT Cognitive Test | 30 Minutes | 1.65 msec | Standard Error 2.1 |
| Paracetamol/ Caffeine Tablet | Adjusted Mean Change From Baseline in Valid Reaction Time to DAT Cognitive Test | 60 minutes | -5.49 msec | Standard Error 2.44 |
| Paracetamol Powder | Adjusted Mean Change From Baseline in Valid Reaction Time to DAT Cognitive Test | 30 Minutes | -7.42 msec | Standard Error 2.07 |
| Paracetamol Powder | Adjusted Mean Change From Baseline in Valid Reaction Time to DAT Cognitive Test | 60 minutes | -12.39 msec | Standard Error 2.43 |
Secondary
Adjusted Mean Change From Baseline in Valid Reaction Time to SAT Cognitive Test
Auditory and visual attention of participants was evaluated using a validated Sustained Attention task. For the sustained visual attention task, participants were required to respond to the letter 's' every time it appears in a continuous stream of letters presented on a screen. For the sustained auditory attention task, participants responded to the number '8' every time it appears in a continuous stream of numbers presented through headphones. Total test duration was approximately 6 minutes. Mean values of valid reaction time to visual and auditory tests were calculated.
Time frame: Baseline, 30 minutes and up to 60 minutes post treatment administration
Population: ITT population: All randomized participants who were randomized and had at least one post-baseline efficacy evaluation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Paracetamol/ Caffeine Tablet | Adjusted Mean Change From Baseline in Valid Reaction Time to SAT Cognitive Test | 30 minutes | -6.49 msec | Standard Error 2.8 |
| Paracetamol/ Caffeine Tablet | Adjusted Mean Change From Baseline in Valid Reaction Time to SAT Cognitive Test | 60 minutes | -10.69 msec | Standard Error 3.12 |
| Paracetamol Powder | Adjusted Mean Change From Baseline in Valid Reaction Time to SAT Cognitive Test | 30 minutes | -6.18 msec | Standard Error 2.75 |
| Paracetamol Powder | Adjusted Mean Change From Baseline in Valid Reaction Time to SAT Cognitive Test | 60 minutes | -9.45 msec | Standard Error 3.1 |
Secondary
Adjusted Mean Change in Baseline in Valid Reaction Time to RVIP Cognitive Test
The RVIP assessed the performance of visual attention mechanisms in remaining vigilant to periodically occurring events. Participants monitored a series of single numbers (0-9) appearing in the centre of the screen. During the RVIP task, participants responded to consecutive sequences of three odd or three even numbers by pressing the corresponding response button as quickly and accurately as possible. Mean valid reaction time was determined.
Time frame: Baseline, 30 minutes and up to 60 minutes post treatment administration
Population: ITT population: All randomized participants who were randomized and had at least one post-baseline efficacy evaluation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Paracetamol/ Caffeine Tablet | Adjusted Mean Change in Baseline in Valid Reaction Time to RVIP Cognitive Test | 30 minutes | 6.00 milliseconds (msec) | Standard Error 3.916 |
| Paracetamol/ Caffeine Tablet | Adjusted Mean Change in Baseline in Valid Reaction Time to RVIP Cognitive Test | 60 minutes | 0.08 milliseconds (msec) | Standard Error 3.983 |
| Paracetamol Powder | Adjusted Mean Change in Baseline in Valid Reaction Time to RVIP Cognitive Test | 30 minutes | 1.88 milliseconds (msec) | Standard Error 3.916 |
| Paracetamol Powder | Adjusted Mean Change in Baseline in Valid Reaction Time to RVIP Cognitive Test | 60 minutes | -4.85 milliseconds (msec) | Standard Error 3.954 |
Secondary
Mean Change From Baseline in Number of Incorrect and Missed Responses to DAT Cognitive Test
For the DAT Cognitive test, auditory and visual stimuli were simultaneously presented and participants were asked to respond to occurrences of 's' (visual) or '8' (auditory). Total test duration was approximately 6 minutes. Mean values of incorrect and missed responses to visual and auditory tests were calculated.
Time frame: Baseline, 30 minutes and up to 60 minutes post treatment administration
Population: ITT population: All randomized participants who were randomized and had at least one post-baseline efficacy evaluation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Paracetamol/ Caffeine Tablet | Mean Change From Baseline in Number of Incorrect and Missed Responses to DAT Cognitive Test | Incorrect responses at 30 minutes | -5.4 Responses | Standard Error 0.83 |
| Paracetamol/ Caffeine Tablet | Mean Change From Baseline in Number of Incorrect and Missed Responses to DAT Cognitive Test | Incorrect responses at 60 minutes | -5.2 Responses | Standard Error 0.77 |
| Paracetamol/ Caffeine Tablet | Mean Change From Baseline in Number of Incorrect and Missed Responses to DAT Cognitive Test | Missed responses at 30 minutes | -6.7 Responses | Standard Error 1.19 |
| Paracetamol/ Caffeine Tablet | Mean Change From Baseline in Number of Incorrect and Missed Responses to DAT Cognitive Test | Missed responses at 60 minutes | -7.4 Responses | Standard Error 1.24 |
| Paracetamol Powder | Mean Change From Baseline in Number of Incorrect and Missed Responses to DAT Cognitive Test | Missed responses at 60 minutes | -1.9 Responses | Standard Error 0.75 |
| Paracetamol Powder | Mean Change From Baseline in Number of Incorrect and Missed Responses to DAT Cognitive Test | Incorrect responses at 30 minutes | -1.4 Responses | Standard Error 0.83 |
| Paracetamol Powder | Mean Change From Baseline in Number of Incorrect and Missed Responses to DAT Cognitive Test | Missed responses at 30 minutes | -2.0 Responses | Standard Error 0.83 |
| Paracetamol Powder | Mean Change From Baseline in Number of Incorrect and Missed Responses to DAT Cognitive Test | Incorrect responses at 60 minutes | -0.2 Responses | Standard Error 0.92 |
Secondary
Mean Change From Baseline in Number of Incorrect and Missed Responses to RVIP Cognitive Test
The RVIP assessed the performance of visual attention mechanisms in remaining vigilant to periodically occurring events. Participants monitored a series of single numbers (0-9) appearing in the centre of the screen. During the RVIP task, participants responded to consecutive sequences of three odd or three even numbers by pressing the corresponding response button as quickly and accurately as possible. The test lasted approximately 9 minutes and mean number of valid responses to stimulus was calculated.
Time frame: Baseline, 30 minutes and up to 60 minutes post treatment administration
Population: ITT population: All randomized participants who were randomized and had at least one post-baseline efficacy evaluation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Paracetamol/ Caffeine Tablet | Mean Change From Baseline in Number of Incorrect and Missed Responses to RVIP Cognitive Test | Missed responses at 30 minutes | -4.8 Responses | Standard Error 0.69 |
| Paracetamol/ Caffeine Tablet | Mean Change From Baseline in Number of Incorrect and Missed Responses to RVIP Cognitive Test | Incorrect responses at 30 minutes | -2.3 Responses | Standard Error 1.57 |
| Paracetamol/ Caffeine Tablet | Mean Change From Baseline in Number of Incorrect and Missed Responses to RVIP Cognitive Test | Missed responses at 60 minutes | -7.1 Responses | Standard Error 0.9 |
| Paracetamol/ Caffeine Tablet | Mean Change From Baseline in Number of Incorrect and Missed Responses to RVIP Cognitive Test | Incorrect responses at 60 minutes | -1.7 Responses | Standard Error 1.93 |
| Paracetamol Powder | Mean Change From Baseline in Number of Incorrect and Missed Responses to RVIP Cognitive Test | Missed responses at 60 minutes | -0.6 Responses | Standard Error 1 |
| Paracetamol Powder | Mean Change From Baseline in Number of Incorrect and Missed Responses to RVIP Cognitive Test | Incorrect responses at 30 minutes | -2.7 Responses | Standard Error 1.52 |
| Paracetamol Powder | Mean Change From Baseline in Number of Incorrect and Missed Responses to RVIP Cognitive Test | Missed responses at 30 minutes | -1.3 Responses | Standard Error 0.89 |
| Paracetamol Powder | Mean Change From Baseline in Number of Incorrect and Missed Responses to RVIP Cognitive Test | Incorrect responses at 60 minutes | -2.7 Responses | Standard Error 1.8 |
Secondary
Mean Change From Baseline in Number of Incorrect and Missed Responses to SAT Cognitive Test
Auditory and visual attention of participants was evaluated using a validated Sustained Attention task. For the sustained visual attention task, participants were required to respond to the letter 's' every time it appears in a continuous stream of letters presented on a screen. For the sustained auditory attention task, participants responded to the number '8' every time it appears in a continuous stream of numbers presented through headphones. Total test duration was approximately 6 minutes. Mean values of incorrect and missed responses to visual and auditory tests were calculated.
Time frame: Baseline, 30 minutes and up to 60 minutes post treatment administration
Population: ITT population: All randomized participants who were randomized and had at least one post-baseline efficacy evaluation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Paracetamol/ Caffeine Tablet | Mean Change From Baseline in Number of Incorrect and Missed Responses to SAT Cognitive Test | Incorrect responses at 30 minutes | -2.3 Responses | Standard Error 0.63 |
| Paracetamol/ Caffeine Tablet | Mean Change From Baseline in Number of Incorrect and Missed Responses to SAT Cognitive Test | Incorrect responses at 60 minutes | -3.6 Responses | Standard Error 0.71 |
| Paracetamol/ Caffeine Tablet | Mean Change From Baseline in Number of Incorrect and Missed Responses to SAT Cognitive Test | Missed responses at 60 minutes | -1.5 Responses | Standard Error 0.54 |
| Paracetamol/ Caffeine Tablet | Mean Change From Baseline in Number of Incorrect and Missed Responses to SAT Cognitive Test | Missed responses at 30 minutes | -1.8 Responses | Standard Error 0.59 |
| Paracetamol Powder | Mean Change From Baseline in Number of Incorrect and Missed Responses to SAT Cognitive Test | Missed responses at 60 minutes | 0.7 Responses | Standard Error 0.55 |
| Paracetamol Powder | Mean Change From Baseline in Number of Incorrect and Missed Responses to SAT Cognitive Test | Incorrect responses at 30 minutes | 0.1 Responses | Standard Error 0.65 |
| Paracetamol Powder | Mean Change From Baseline in Number of Incorrect and Missed Responses to SAT Cognitive Test | Incorrect responses at 60 minutes | 0.6 Responses | Standard Error 0.72 |
| Paracetamol Powder | Mean Change From Baseline in Number of Incorrect and Missed Responses to SAT Cognitive Test | Missed responses at 30 minutes | 0.5 Responses | Standard Error 0.44 |