Trial Outcomes & Findings for Effects of Two Doses of a Common Cold Treatment on Alertness (NCT NCT01686646)

NCT ID: NCT01686646

Last Updated: 2014-12-08

Results Overview

The RVIP assessed the performance of visual attention mechanisms in remaining vigilant to periodically occurring events. The number of accurate responses to RVIP task was determined from the cognitive function computerised output. 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. This was identified in the output file by a value of '1' in 'TARGET=1' column. Also, the response time (in seconds) was recorded in the 'RT' column. If the subject correctly responded to the target, this was identified by a value of '1' in the 'CORRECT=1' column. The number of accurate responses was calculated as the total number of records where 'CORRECT=1' had a value of '1'. The test lasted approximately 9 minutes and number of accurate responses to stimulus was calculated.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 240 participants
• Primary outcome timeframe: Baseline to 60 minutes post treatment administration
• Results posted on: 2014-12-08

Participant Flow

Participants were recruited at the clinical site.

Out of 244 participants screened, 4 did not meet the study criteria. Remaining 240 were randomized into the study.

Participant milestones

Measure	Paracetamol + Caffeine Combination (1000/130) Two paracetamol (500 milligrams \[mg\] ) and caffeine (65 mg) tablets were dissolved in 200 milliliter (mL) of water and administered orally.	Paracetamol (1000) Two paracetamol tablets (500 mg each) were dissolved in 200 mL of water and administered orally.	Paracetamol + Caffeine Combination (500/65) One paracetamol (500 mg) and caffeine (65 mg) tablet was dissolved in 200 mL of water and administered orally.	Paracetamol (500) One paracetamol tablet (500 mg) was dissolved in 200 mL of water and administered orally.
Overall Study STARTED	45	45	75	75
Overall Study Intent to Treat Population	45	45	75	75
Overall Study Safety Population	46	45	74	75
Overall Study COMPLETED	45	45	75	75
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effects of Two Doses of a Common Cold Treatment on Alertness

Baseline characteristics by cohort

Measure	Paracetamol + Caffeine Combination (1000/130) n=46 Participants Two paracetamol (500 mg) and caffeine (65 mg) tablets were dissolved in 200 mL of water and administered orally.	Paracetamol (1000) n=45 Participants Two paracetamol tablets (500 mg each) were dissolved in 200 mL of water and administered orally.	Paracetamol + Caffeine Combination (500/65) n=74 Participants One paracetamol (500 mg) and caffeine (65 mg) tablet was dissolved in 200 mL of water and administered orally.	Paracetamol (500) n=75 Participants One paracetamol tablet (500 mg) was dissolved in 200 mL of water and administered orally.	Total n=240 Participants Total of all reporting groups
Age, Continuous	20.0 Years STANDARD_DEVIATION 1.56 • n=5 Participants	20.0 Years STANDARD_DEVIATION 1.74 • n=7 Participants	20.6 Years STANDARD_DEVIATION 4.19 • n=5 Participants	20.2 Years STANDARD_DEVIATION 2.80 • n=4 Participants	20.2 Years STANDARD_DEVIATION 2.98 • n=21 Participants
Sex: Female, Male Female	31 Participants n=5 Participants	28 Participants n=7 Participants	47 Participants n=5 Participants	48 Participants n=4 Participants	154 Participants n=21 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	17 Participants n=7 Participants	27 Participants n=5 Participants	27 Participants n=4 Participants	86 Participants n=21 Participants

PRIMARY outcome

Timeframe: Baseline to 60 minutes post treatment administration

Population: Intent to Treat (ITT) population: all randomized participants who received study treatment and had at least one post-baseline efficacy evaluation.

The RVIP assessed the performance of visual attention mechanisms in remaining vigilant to periodically occurring events. The number of accurate responses to RVIP task was determined from the cognitive function computerised output. 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. This was identified in the output file by a value of '1' in 'TARGET=1' column. Also, the response time (in seconds) was recorded in the 'RT' column. If the subject correctly responded to the target, this was identified by a value of '1' in the 'CORRECT=1' column. The number of accurate responses was calculated as the total number of records where 'CORRECT=1' had a value of '1'. The test lasted approximately 9 minutes and number of accurate responses to stimulus was calculated.

Outcome measures

Measure	Paracetamol + Caffeine Combination (1000/130) n=45 Participants Two paracetamol (500 mg) and caffeine (65 mg) tablets were dissolved in 200 mL of water and administered orally.	Paracetamol (1000) n=45 Participants Two paracetamol tablets (500 mg each) were dissolved in 200 mL of water and administered orally.	Paracetamol + Caffeine Combination (500/65) n=75 Participants One paracetamol (500 mg) and caffeine (65 mg) tablet was dissolved in 200 mL of water and administered orally.	Paracetamol (500) n=75 Participants One paracetamol tablet (500 mg) was dissolved in 200 mL of water and administered orally.
Change From Baseline in Number of Accurate Responses to Rapid Visual Information Processing (RVIP) Cognitive Test	8.3 Correct responses Standard Error 1.12	4.8 Correct responses Standard Error 1.12	4.5 Correct responses Standard Error 0.89	2.7 Correct responses Standard Error 0.88

SECONDARY outcome

Timeframe: Baseline to 120 minutes post treatment administration

Population: ITT population: all randomized participants who received study treatment and had at least one post-baseline efficacy evaluation.

The RVIP assessed the performance of visual attention mechanisms in remaining vigilant to periodically occurring events. The number of accurate responses to RVIP task was determined from the cognitive function computerised output. 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. This was identified in the output file by a value of '1' in 'TARGET=1' column. Also, the response time (in seconds) was recorded in the 'RT' column. If the subject correctly responded to the target, this was identified by a value of '1' in the 'CORRECT=1' column. The number of accurate responses was calculated as the total number of records where 'CORRECT=1' had a value of '1'. The test lasted approximately 9 minutes and number of accurate responses to stimulus was calculated.

Outcome measures

Measure	Paracetamol + Caffeine Combination (1000/130) n=45 Participants Two paracetamol (500 mg) and caffeine (65 mg) tablets were dissolved in 200 mL of water and administered orally.	Paracetamol (1000) n=45 Participants Two paracetamol tablets (500 mg each) were dissolved in 200 mL of water and administered orally.	Paracetamol + Caffeine Combination (500/65) n=75 Participants One paracetamol (500 mg) and caffeine (65 mg) tablet was dissolved in 200 mL of water and administered orally.	Paracetamol (500) n=75 Participants One paracetamol tablet (500 mg) was dissolved in 200 mL of water and administered orally.
Change From Baseline in Number of Accurate Responses to RVIP Cognitive Test	7.3 Correct responses Standard Error 1.16	4.4 Correct responses Standard Error 1.15	6.2 Correct responses Standard Error 0.91	3.5 Correct responses Standard Error 0.92

SECONDARY outcome

Timeframe: Baseline, 60 minutes and upto 120 minutes post treatment administration

Population: ITT population: all randomized participants who received study treatment and had at least one post-baseline efficacy evaluation.

The mean time of accurate responses was defined as the mean reaction time for the correct responses. For records with '1' in the 'CORRECT=1' column, the mean time of accurate response was calculated as the summation of the response time values divided by number of records with '1' in the 'CORRECT=1' column. The result was multiplied by 1000 to convert into milliseconds (msecs).

Outcome measures

Measure	Paracetamol + Caffeine Combination (1000/130) n=45 Participants Two paracetamol (500 mg) and caffeine (65 mg) tablets were dissolved in 200 mL of water and administered orally.	Paracetamol (1000) n=45 Participants Two paracetamol tablets (500 mg each) were dissolved in 200 mL of water and administered orally.	Paracetamol + Caffeine Combination (500/65) n=75 Participants One paracetamol (500 mg) and caffeine (65 mg) tablet was dissolved in 200 mL of water and administered orally.	Paracetamol (500) n=75 Participants One paracetamol tablet (500 mg) was dissolved in 200 mL of water and administered orally.
Change From Baseline in Mean Time of Accurate Responses to RVIP Cognitive Task 60 minutes	-1.4 milliseconds (msec) Interval -92.0 to 102.0	2.4 milliseconds (msec) Interval -113.0 to 313.0	-0.9 milliseconds (msec) Interval -134.0 to 119.0	-9.9 milliseconds (msec) Interval -108.0 to 142.0
Change From Baseline in Mean Time of Accurate Responses to RVIP Cognitive Task 120 minutes	-10.3 milliseconds (msec) Interval -62.0 to 125.0	-6.0 milliseconds (msec) Interval -86.0 to 71.0	-12.5 milliseconds (msec) Interval -91.0 to 109.0	-14.0 milliseconds (msec) Interval -144.0 to 136.0

SECONDARY outcome

Timeframe: Baseline, 60 minutes and up to 120 minutes post treatment administration

Population: ITT population: all randomized participants who received study treatment and had at least one post-baseline efficacy evaluation.

The no. of inaccurate responses to RVIP was determined from cognitive function computerised output. Participants monitored a series of single numbers (0-9) appearing in the centre of screen. They responded to consecutive sequences of 3 odd or even numbers by pressing the corresponding response button. This was identified in the output file by a value of '1' in the 'TARGET=1' column. If a subject responded incorrectly to stimuli (pressed the response button at the wrong time), this was identified by a value of '-1' in the 'CORRECT=1' column. The no. of incorrect responses was calculated as the total no. of records where 'CORRECT=1' had a value of '-1'. If the subject missed a target (failed to press the response button within 600 msecs of being presented with a string of 3 consecutive even or odd numbers), this was considered a missed response and was calculated as the no. of records where there was a value of '1' in the 'TARGET=1' column and a value of '0' in the 'CORRECT=1' column.

Outcome measures

Measure	Paracetamol + Caffeine Combination (1000/130) n=45 Participants Two paracetamol (500 mg) and caffeine (65 mg) tablets were dissolved in 200 mL of water and administered orally.	Paracetamol (1000) n=45 Participants Two paracetamol tablets (500 mg each) were dissolved in 200 mL of water and administered orally.	Paracetamol + Caffeine Combination (500/65) n=75 Participants One paracetamol (500 mg) and caffeine (65 mg) tablet was dissolved in 200 mL of water and administered orally.	Paracetamol (500) n=75 Participants One paracetamol tablet (500 mg) was dissolved in 200 mL of water and administered orally.
Change From Baseline in Number of Inaccurate and Missed Responses to RVIP Cognitive Task Incorrect responses at 60 minutes	-5.7 inaccurate and missed responses Standard Error 3.43	-2.8 inaccurate and missed responses Standard Error 1.38	1.4 inaccurate and missed responses Standard Error 1.96	-2.4 inaccurate and missed responses Standard Error 1.82
Change From Baseline in Number of Inaccurate and Missed Responses to RVIP Cognitive Task Incorrect responses at 120 minutes	-4.5 inaccurate and missed responses Standard Error 4.12	-1.7 inaccurate and missed responses Standard Error 1.78	-0.8 inaccurate and missed responses Standard Error 1.97	-3.3 inaccurate and missed responses Standard Error 1.56
Change From Baseline in Number of Inaccurate and Missed Responses to RVIP Cognitive Task Missed responses at 60 minutes	-8.1 inaccurate and missed responses Standard Error 1.03	-4.8 inaccurate and missed responses Standard Error 1.18	-4.8 inaccurate and missed responses Standard Error 0.83	-3.1 inaccurate and missed responses Standard Error 0.89
Change From Baseline in Number of Inaccurate and Missed Responses to RVIP Cognitive Task Missed responses at 120 minutes	-7.6 inaccurate and missed responses Standard Error 1.14	-4.8 inaccurate and missed responses Standard Error 1.15	-6.5 inaccurate and missed responses Standard Error 0.80	-3.5 inaccurate and missed responses Standard Error 0.92

SECONDARY outcome

Timeframe: Baseline, 60 minutes and up to 120 minutes post treatment administration

Population: ITT population: all randomized participants who received study treatment and had at least one post-baseline efficacy evaluation.

Auditory and visual attention of participants was evaluated using a validated Sustained Attention task. For the sustained auditory attention task, participants were required to respond whenever they heard the number '8' in a continuous stream of numbers presented through headphones. This was identified in the output file by a value of '8' in the 'NUMBER' column. For the sustained visual attention task, participants were required to respond to the letter 's' every time it appeared in a continuous stream of letters presented on a screen. This was identified in the output file by a value of 's' in the 'LETTER' column. If the subject correctly responded to the target, this was identified by a value of '1' in the 'CORRECT=1' column. The number of accurate responses was calculated as the total number of records where 'CORRECT=1' had a value of '1'.

Outcome measures

Measure	Paracetamol + Caffeine Combination (1000/130) n=45 Participants Two paracetamol (500 mg) and caffeine (65 mg) tablets were dissolved in 200 mL of water and administered orally.	Paracetamol (1000) n=45 Participants Two paracetamol tablets (500 mg each) were dissolved in 200 mL of water and administered orally.	Paracetamol + Caffeine Combination (500/65) n=75 Participants One paracetamol (500 mg) and caffeine (65 mg) tablet was dissolved in 200 mL of water and administered orally.	Paracetamol (500) n=75 Participants One paracetamol tablet (500 mg) was dissolved in 200 mL of water and administered orally.
Change From Baseline in Number of Accurate Responses to Sustained Attention Tasks (SAT) Cognitive Test Number of Accurate Responses to SAT at 60 mins	1.0 Correct responses Interval -4.0 to 16.0	0.5 Correct responses Interval -16.0 to 43.0	2.0 Correct responses Interval -9.0 to 33.0	0.0 Correct responses Interval -28.0 to 15.0
Change From Baseline in Number of Accurate Responses to Sustained Attention Tasks (SAT) Cognitive Test Number of Accurate Responses to SAT at 120 mins	2.0 Correct responses Interval -17.0 to 28.0	1.0 Correct responses Interval -11.0 to 42.0	1.0 Correct responses Interval -6.0 to 30.0	2.0 Correct responses Interval -10.0 to 26.0

SECONDARY outcome

Timeframe: Baseline, 30 minutes and up to 60 minutes post treatment administration

Population: ITT population: all randomized participants who received study treatment and had at least one post-baseline efficacy evaluation.

The mean time of accurate responses was defined as the mean reaction time for the correct responses. For records with '1' in the 'CORRECT=1' column, the mean time of accurate response was calculated as the summation of the response time values divided by number of records with '1' in the 'CORRECT=1' column. The result was multiplied by 1000 to convert into milliseconds (msecs).

Outcome measures

Measure	Paracetamol + Caffeine Combination (1000/130) n=45 Participants Two paracetamol (500 mg) and caffeine (65 mg) tablets were dissolved in 200 mL of water and administered orally.	Paracetamol (1000) n=45 Participants Two paracetamol tablets (500 mg each) were dissolved in 200 mL of water and administered orally.	Paracetamol + Caffeine Combination (500/65) n=75 Participants One paracetamol (500 mg) and caffeine (65 mg) tablet was dissolved in 200 mL of water and administered orally.	Paracetamol (500) n=75 Participants One paracetamol tablet (500 mg) was dissolved in 200 mL of water and administered orally.
Change From Baseline in Mean Time of Accurate Responses to SAT Cognitive Task 60 minutes	-16.7 msec Standard Error 3.17	-9.8 msec Standard Error 3.17	-10.8 msec Standard Error 2.51	-12.0 msec Standard Error 2.47
Change From Baseline in Mean Time of Accurate Responses to SAT Cognitive Task 120 minutes	-21.2 msec Standard Error 3.48	-10.4 msec Standard Error 3.48	-18.0 msec Standard Error 2.74	-15.4 msec Standard Error 2.72

SECONDARY outcome

Timeframe: Baseline, 60 minutes and up to 120 minutes post treatment administration

Population: ITT population: all randomized participants who received study treatment and had at least one post-baseline efficacy evaluation.

For sustained auditory attention task, participants were required to respond on hearing the no. '8' in a continuous stream of numbers through headphones. It was identified in output file by a value of '8' in 'NUMBER' column. For sustained visual attention task, participants responded to letter 's' every time it appeared in a continuous stream of letters presented on screen. This was identified in output file by a value of 's' in 'LETTER' column. If a subject responded incorrectly (pressed the response button at the wrong time), it was identified by a value of '-1' in 'CORRECT=1' column. The no. of incorrect responses was calculated as total no. of records where 'CORRECT=1' had a value of '-1'. The no. of missed responses (when subject failed to press the response button on hearing the number '8' or seeing the letter 's'), was calculated as the no. of records where there was a value of '8' in 'NUMBER' column or 's' in the 'LETTER' column and a value of '0' in the 'CORRECT=1' column.

Outcome measures

Measure	Paracetamol + Caffeine Combination (1000/130) n=45 Participants Two paracetamol (500 mg) and caffeine (65 mg) tablets were dissolved in 200 mL of water and administered orally.	Paracetamol (1000) n=45 Participants Two paracetamol tablets (500 mg each) were dissolved in 200 mL of water and administered orally.	Paracetamol + Caffeine Combination (500/65) n=75 Participants One paracetamol (500 mg) and caffeine (65 mg) tablet was dissolved in 200 mL of water and administered orally.	Paracetamol (500) n=75 Participants One paracetamol tablet (500 mg) was dissolved in 200 mL of water and administered orally.
Change From Baseline in Number of Incorrect and Missed Responses to SAT Cognitive Test Incorrect responses at 60 minutes	-4.6 incorrect and missed responses Standard Error 1.00	-1.1 incorrect and missed responses Standard Error 0.87	-4.2 incorrect and missed responses Standard Error 0.74	-1.6 incorrect and missed responses Standard Error 0.71
Change From Baseline in Number of Incorrect and Missed Responses to SAT Cognitive Test Incorrect responses at 120 minutes	-4.4 incorrect and missed responses Standard Error 1.04	-2.3 incorrect and missed responses Standard Error 0.98	-4.3 incorrect and missed responses Standard Error 0.88	-2.8 incorrect and missed responses Standard Error 0.82
Change From Baseline in Number of Incorrect and Missed Responses to SAT Cognitive Test Missed responses at 60 minutes	-2.7 incorrect and missed responses Standard Error 0.74	-1.9 incorrect and missed responses Standard Error 1.25	-2.3 incorrect and missed responses Standard Error 0.70	-0.8 incorrect and missed responses Standard Error 0.66
Change From Baseline in Number of Incorrect and Missed Responses to SAT Cognitive Test Missed responses at 120 minutes	-2.8 incorrect and missed responses Standard Error 1.11	-2.0 incorrect and missed responses Standard Error 1.19	-2.2 incorrect and missed responses Standard Error 0.64	-2.4 incorrect and missed responses Standard Error 0.63

SECONDARY outcome

Timeframe: Baseline, 60 minutes and up to 120 minutes post treatment administration

Population: ITT population: all randomized participants who received study treatment and had at least one post-baseline efficacy evaluation.

Auditory and visual attention of participants was evaluated using a validated Divided Attention task. Participants were required to respond whenever they heard the number '8' in a continuous stream of numbers presented through headphones or saw a letter 's' on the screen . This was identified in the output file by a value of '8' in the 'NUMBER' column or by a value of 's' in the 'LETTER' column. If the subject correctly responded to the target, this was identified by a value of '1' in the 'CORRECT=1' column. The number of accurate responses was calculated as the total number of records where 'CORRECT=1' had a value of '1'.

Outcome measures

Measure	Paracetamol + Caffeine Combination (1000/130) n=45 Participants Two paracetamol (500 mg) and caffeine (65 mg) tablets were dissolved in 200 mL of water and administered orally.	Paracetamol (1000) n=45 Participants Two paracetamol tablets (500 mg each) were dissolved in 200 mL of water and administered orally.	Paracetamol + Caffeine Combination (500/65) n=75 Participants One paracetamol (500 mg) and caffeine (65 mg) tablet was dissolved in 200 mL of water and administered orally.	Paracetamol (500) n=75 Participants One paracetamol tablet (500 mg) was dissolved in 200 mL of water and administered orally.
Change From Baseline in Number of Valid Responses to Divided Attention Task (DAT) Cognitive Test 60 minutes	10.0 Correct responses Interval -9.0 to 34.0	6.0 Correct responses Interval -35.0 to 66.0	8.0 Correct responses Interval -9.0 to 45.0	5.5 Correct responses Interval -27.0 to 82.0
Change From Baseline in Number of Valid Responses to Divided Attention Task (DAT) Cognitive Test 120 minutes	11.0 Correct responses Interval -6.0 to 53.0	6.0 Correct responses Interval -15.0 to 88.0	9.0 Correct responses Interval -23.0 to 59.0	7.0 Correct responses Interval -23.0 to 86.0

SECONDARY outcome

Timeframe: Baseline, 60 minutes and up to 120 minutes post treatment administration

Population: ITT population: all randomized participants who received study treatment and had at least one post-baseline efficacy evaluation.

The mean time of accurate responses was defined as the mean reaction time for the correct responses. For records with '1' in the 'CORRECT=1' column, the mean time of accurate response was calculated as the summation of the response time values divided by number of records with '1' in the 'CORRECT=1' column. The result was multiplied by 1000 to convert into milliseconds (msecs).

Outcome measures

Measure	Paracetamol + Caffeine Combination (1000/130) n=45 Participants Two paracetamol (500 mg) and caffeine (65 mg) tablets were dissolved in 200 mL of water and administered orally.	Paracetamol (1000) n=45 Participants Two paracetamol tablets (500 mg each) were dissolved in 200 mL of water and administered orally.	Paracetamol + Caffeine Combination (500/65) n=75 Participants One paracetamol (500 mg) and caffeine (65 mg) tablet was dissolved in 200 mL of water and administered orally.	Paracetamol (500) n=75 Participants One paracetamol tablet (500 mg) was dissolved in 200 mL of water and administered orally.
Change From Baseline in Mean Time of Accurate Responses to DAT Cognitive Test 120 minutes	-11.0 msec Standard Error 3.00	-5.3 msec Standard Error 3.00	-8.0 msec Standard Error 2.37	-4.6 msec Standard Error 2.34
Change From Baseline in Mean Time of Accurate Responses to DAT Cognitive Test 60 minutes	-3.0 msec Standard Error 2.94	1.5 msec Standard Error 2.94	-4.4 msec Standard Error 2.33	-2.2 msec Standard Error 2.28

SECONDARY outcome

Timeframe: Baseline, 60 minutes and up to 120 minutes post treatment administration

Population: ITT population: all randomized participants who received study treatment and had at least one post-baseline efficacy evaluation.

For the Divided Attention task, participants were required to respond on hearing the no. '8' in a continuous stream of numbers through headphones or seeing a letter 's' on screen. This was identified in the output file by a value of '8' in 'NUMBER' column or 's' in 'LETTER' column. If a subject responded incorrectly (pressed the response button at the wrong time), this was identified by a value of '-1' in 'CORRECT=1' column. The number of incorrect responses was calculated as the total no. of records where 'CORRECT=1' had a value of '-1'. If the subject missed a target (failed to press the response button on hearing the no. '8' or seeing the letter 's'), this was considered a missed response. The number of missed responses was calculated as the no. of records where there was a value of '8' in 'NUMBER' column or 's' in 'LETTER' column and a value of '0' in the 'CORRECT=1' column.

Outcome measures

Measure	Paracetamol + Caffeine Combination (1000/130) n=45 Participants Two paracetamol (500 mg) and caffeine (65 mg) tablets were dissolved in 200 mL of water and administered orally.	Paracetamol (1000) n=45 Participants Two paracetamol tablets (500 mg each) were dissolved in 200 mL of water and administered orally.	Paracetamol + Caffeine Combination (500/65) n=75 Participants One paracetamol (500 mg) and caffeine (65 mg) tablet was dissolved in 200 mL of water and administered orally.	Paracetamol (500) n=75 Participants One paracetamol tablet (500 mg) was dissolved in 200 mL of water and administered orally.
Change From Baseline in Number of Incorrect and Missed Responses to DAT Cognitive Test Incorrect responses at 60 minutes	-6.5 incorrect and missed responses Standard Error 1.02	-4.2 incorrect and missed responses Standard Error 1.11	-5.4 incorrect and missed responses Standard Error 0.87	-3.3 incorrect and missed responses Standard Error 0.81
Change From Baseline in Number of Incorrect and Missed Responses to DAT Cognitive Test Incorrect responses at 120 minutes	-7.1 incorrect and missed responses Standard Error 1.01	-4.9 incorrect and missed responses Standard Error 1.10	-5.6 incorrect and missed responses Standard Error 0.86	-5.0 incorrect and missed responses Standard Error 0.98
Change From Baseline in Number of Incorrect and Missed Responses to DAT Cognitive Test Missed responses at 60 minutes	-10.2 incorrect and missed responses Standard Error 1.27	-7.6 incorrect and missed responses Standard Error 2.08	-9.8 incorrect and missed responses Standard Error 1.19	-6.2 incorrect and missed responses Standard Error 1.50
Change From Baseline in Number of Incorrect and Missed Responses to DAT Cognitive Test Missed responses at 120 minutes	-12.2 incorrect and missed responses Standard Error 1.54	-9.1 incorrect and missed responses Standard Error 2.27	-10.2 incorrect and missed responses Standard Error 1.43	-7.8 incorrect and missed responses Standard Error 1.58

Adverse Events

Paracetamol + Caffeine Combination (1000/130)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Paracetamol (1000)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Paracetamol + Caffeine Combination (500/65)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Paracetamol (500)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER