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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paracetamol and Caffeine | Experimental | Paracetamol and caffeine |
|
| Paracetamol | Active Comparator | Paracetamol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paracetamol and Caffeine | Drug | Paracetamol 1000 mg and caffeine 130 mg |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to 30 minutes post treatment administration |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Common Cold Centre | Cardiff | Wales | United Kingdom |
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 were recruited at the clinical site.
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| ID | Title | Description |
|---|---|---|
| FG000 | Paracetamol/ Caffeine Tablet Then Paracetamol Powder | Participants were orally administered with 200 millilitre (mL) solution of two soluble tablets, [each tablet containing 500 milligram (mg) paracetamol and 65 mg of caffeine], then 200 mL solution of paracetamol soluble powder (1000 mg). A washout period of 5 hours was maintained. |
| FG001 | Paracetamol Powder Then Paracetamol/ Caffeine Tablet | Participants were orally administered with 200 mL solution of paracetamol soluble powder (1000 mg), then 200 mL solution of two soluble tablets [each tablet containing 500 mg paracetamol and 65 mg of caffeine]. A washout period of 5 hours was maintained. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period I - First Intervention |
|
| |||||||||||||||||||||
| Period II - Second Intervention |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Randomized Participants | All randomized participants were evaluated for baseline measures. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Intent-To-Treat (ITT) population: All randomized participants who were randomized and had at least one post-baseline efficacy evaluation. | Posted | Mean | Standard Deviation | Valid responses | Baseline to 30 minutes post treatment administration |
|
Adverse Events were collected from the start of the investigational product and until 5 days following last administration of the investigational product.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Paracetamol/Caffeine Tablet | Participants were orally administered with 200 mL solution of two soluble tablets, each tablet containing 500 mg paracetamol and 65 mg of caffeine. |
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Apparent carryover effect from the paracetamol/ caffeine treatment taken in Period 1 into the baseline assessment of Period 2 was observed, hence the statistical analysis was amended after unblinding the statistician.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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| ID | Term |
|---|---|
| D003139 | Common Cold |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| D002110 | Caffeine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Paracetamol |
| Drug |
Paracetamol 1000 mg |
|
| Baseline to 60 minutes post treatment administration |
| 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. | 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 | 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. | 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 | 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. | 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 | 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. | Baseline, 30 minutes and up to 60 minutes post treatment administration |
| 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. | 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 | 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. | Baseline, 30 minutes and up to 60 minutes post treatment administration |
| 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. | 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 | 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. | 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 | 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. | Baseline, 30 minutes and up to 60 minutes post treatment administration |
| NOT COMPLETED |
|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Participants were orally administered with 200 mL solution of two soluble tablets, each tablet containing 500 mg paracetamol and 65 mg of caffeine.
| OG001 | Paracetamol Powder | Participants were orally administered with 200 mL solution of 1000 mg paracetamol soluble powder. |
|
|
|
| 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. | ITT population: All randomized participants who were randomized and had at least one post-baseline efficacy evaluation. | Posted | Mean | Standard Deviation | Valid responses | Baseline to 60 minutes post treatment administration |
|
|
|
|
| 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. | ITT population: All randomized participants who were randomized and had at least one post-baseline efficacy evaluation. | Posted | Mean | Standard Error | milliseconds (msec) | Baseline, 30 minutes and up to 60 minutes post treatment administration |
|
|
|
| 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. | ITT population: All randomized participants who were randomized and had at least one post-baseline efficacy evaluation. | Posted | Mean | Standard Error | Responses | Baseline, 30 minutes and up to 60 minutes post treatment administration |
|
|
|
| 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. | ITT population: All randomized participants who were randomized and had at least one post-baseline efficacy evaluation. | Posted | Mean | Standard Error | Valid responses | Baseline, 30 minutes and up to 60 minutes post treatment administration |
|
|
|
| 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. | ITT population: All randomized participants who were randomized and had at least one post-baseline efficacy evaluation. | Posted | Mean | Standard Error | Responses | Baseline, 30 minutes and up to 60 minutes post treatment administration |
|
|
|
| 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. | ITT population: All randomized participants who were randomized and had at least one post-baseline efficacy evaluation. | Posted | Mean | Standard Error | msec | Baseline, 30 minutes and up to 60 minutes post treatment administration |
|
|
|
| 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. | ITT population: All randomized participants who were randomized and had at least one post-baseline efficacy evaluation. | Posted | Mean | Standard Error | Valid responses | Baseline, 30 minutes and up to 60 minutes post treatment administration |
|
|
|
| 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. | ITT population: All randomized participants who were randomized and had at least one post-baseline efficacy evaluation. | Posted | Mean | Standard Error | msec | Baseline, 30 minutes and up to 60 minutes post treatment administration |
|
|
|
| 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. | ITT population: All randomized participants who were randomized and had at least one post-baseline efficacy evaluation. | Posted | Mean | Standard Error | Responses | Baseline, 30 minutes and up to 60 minutes post treatment administration |
|
|
|
| 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. | ITT population: All randomized participants who were randomized and had at least one post-baseline efficacy evaluation. | Posted | Mean | Standard Error | Score on a scale | Baseline, 30 minutes and up to 60 minutes post treatment administration |
|
|
|
| 0 |
| 71 |
| 0 |
| 71 |
| EG001 | Paracetamol Powder | Participants were orally administered with 200 mL solution of 1000 mg paracetamol soluble powder. | 0 | 71 | 0 | 71 |
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D014777 |
| Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| Aniline Compounds |
| D000588 | Amines |
| D014970 | Xanthines |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| Missed responses at 30 minutes |
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| Missed responses at 60 minutes |
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| Missed responses at 30 minutes |
|
| Missed responses at 60 minutes |
|
| Missed responses at 30 minutes |
|
| Missed responses at 60 minutes |
|
| Anxiety at 30 minutes |
|
| Anxiety at 60 minutes |
|
| Headache at 30 minutes |
|
| Headache at 60 minutes |
|