Trial Outcomes & Findings for Effects of a Common Cold Treatment on Cognitive Function (NCT NCT01466348)

NCT ID: NCT01466348

Last Updated: 2013-11-25

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 72 participants
• Primary outcome timeframe: Baseline to 30 minutes post treatment administration
• Results posted on: 2013-11-25

Participant Flow

Participants were recruited at the clinical site.

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.

Participant milestones

Measure	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.	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.
Period I - First Intervention STARTED	36	36
Period I - First Intervention Intent To Treat (ITT) Population	36	35
Period I - First Intervention COMPLETED	36	35
Period I - First Intervention NOT COMPLETED	0	1
Period II - Second Intervention STARTED	35	36
Period II - Second Intervention COMPLETED	35	36
Period II - Second Intervention NOT COMPLETED	0	0

Reasons for withdrawal

Measure	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.	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.
Period I - First Intervention Withdrawal by Subject	0	1

Baseline Characteristics

Effects of a Common Cold Treatment on Cognitive Function

Baseline characteristics by cohort

Measure	All Randomized Participants n=71 Participants All randomized participants were evaluated for baseline measures.
Age Continuous	20.8 Years STANDARD_DEVIATION 4.19 • n=5 Participants
Sex: Female, Male Female	47 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Paracetamol/ Caffeine Tablet n=71 Participants Participants were orally administered with 200 mL solution of two soluble tablets, each tablet containing 500 mg paracetamol and 65 mg of caffeine.	Paracetamol Powder n=71 Participants Participants were orally administered with 200 mL solution of 1000 mg paracetamol soluble powder.
Adjusted Mean Change From Baseline in Number of Valid Responses to Rapid Visual Information Processing (RVIP) Cognitive Test	4.8 Valid responses Standard Deviation 0.80	1.3 Valid responses Standard Deviation 0.80

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Paracetamol/ Caffeine Tablet n=71 Participants Participants were orally administered with 200 mL solution of two soluble tablets, each tablet containing 500 mg paracetamol and 65 mg of caffeine.	Paracetamol Powder n=71 Participants Participants were orally administered with 200 mL solution of 1000 mg paracetamol soluble powder.
Adjusted Mean Change From Baseline in Number of Valid Responses to RVIP Cognitive Test	7.1 Valid responses Standard Deviation 0.93	0.6 Valid responses Standard Deviation 0.93

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Paracetamol/ Caffeine Tablet n=71 Participants Participants were orally administered with 200 mL solution of two soluble tablets, each tablet containing 500 mg paracetamol and 65 mg of caffeine.	Paracetamol Powder n=71 Participants Participants were orally administered with 200 mL solution of 1000 mg paracetamol soluble powder.
Adjusted Mean Change in Baseline in Valid Reaction Time to RVIP Cognitive Test 30 minutes	6.00 milliseconds (msec) Standard Error 3.916	1.88 milliseconds (msec) Standard Error 3.916
Adjusted Mean Change in Baseline in Valid Reaction Time to RVIP Cognitive Test 60 minutes	0.08 milliseconds (msec) Standard Error 3.983	-4.85 milliseconds (msec) Standard Error 3.954

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Paracetamol/ Caffeine Tablet n=71 Participants Participants were orally administered with 200 mL solution of two soluble tablets, each tablet containing 500 mg paracetamol and 65 mg of caffeine.	Paracetamol Powder n=71 Participants Participants were orally administered with 200 mL solution of 1000 mg paracetamol soluble powder.
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	-2.7 Responses Standard Error 1.52
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	-2.7 Responses Standard Error 1.80
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	-1.3 Responses Standard Error 0.89
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 0.90	-0.6 Responses Standard Error 1.00

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Paracetamol/ Caffeine Tablet n=71 Participants Participants were orally administered with 200 mL solution of two soluble tablets, each tablet containing 500 mg paracetamol and 65 mg of caffeine.	Paracetamol Powder n=71 Participants Participants were orally administered with 200 mL solution of 1000 mg paracetamol soluble powder.
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	-0.5 Valid responses Standard Error 0.51
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	-0.7 Valid responses Standard Error 0.55

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Paracetamol/ Caffeine Tablet n=71 Participants Participants were orally administered with 200 mL solution of two soluble tablets, each tablet containing 500 mg paracetamol and 65 mg of caffeine.	Paracetamol Powder n=71 Participants Participants were orally administered with 200 mL solution of 1000 mg paracetamol soluble powder.
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	0.1 Responses Standard Error 0.65
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	0.6 Responses Standard Error 0.72
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	0.5 Responses Standard Error 0.44
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	0.7 Responses Standard Error 0.55

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Paracetamol/ Caffeine Tablet n=71 Participants Participants were orally administered with 200 mL solution of two soluble tablets, each tablet containing 500 mg paracetamol and 65 mg of caffeine.	Paracetamol Powder n=71 Participants Participants were orally administered with 200 mL solution of 1000 mg paracetamol soluble powder.
Adjusted Mean Change From Baseline in Valid Reaction Time to SAT Cognitive Test 30 minutes	-6.49 msec Standard Error 2.80	-6.18 msec Standard Error 2.75
Adjusted Mean Change From Baseline in Valid Reaction Time to SAT Cognitive Test 60 minutes	-10.69 msec Standard Error 3.12	-9.45 msec Standard Error 3.10

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Paracetamol/ Caffeine Tablet n=71 Participants Participants were orally administered with 200 mL solution of two soluble tablets, each tablet containing 500 mg paracetamol and 65 mg of caffeine.	Paracetamol Powder n=71 Participants Participants were orally administered with 200 mL solution of 1000 mg paracetamol soluble powder.
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 1.00	2.0 Valid responses Standard Error 0.99
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	1.9 Valid responses Standard Error 1.00

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Paracetamol/ Caffeine Tablet n=71 Participants Participants were orally administered with 200 mL solution of two soluble tablets, each tablet containing 500 mg paracetamol and 65 mg of caffeine.	Paracetamol Powder n=71 Participants Participants were orally administered with 200 mL solution of 1000 mg paracetamol soluble powder.
Adjusted Mean Change From Baseline in Valid Reaction Time to DAT Cognitive Test 30 Minutes	1.65 msec Standard Error 2.10	-7.42 msec Standard Error 2.07
Adjusted Mean Change From Baseline in Valid Reaction Time to DAT Cognitive Test 60 minutes	-5.49 msec Standard Error 2.44	-12.39 msec Standard Error 2.43

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Paracetamol/ Caffeine Tablet n=71 Participants Participants were orally administered with 200 mL solution of two soluble tablets, each tablet containing 500 mg paracetamol and 65 mg of caffeine.	Paracetamol Powder n=71 Participants Participants were orally administered with 200 mL solution of 1000 mg paracetamol soluble powder.
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	-1.4 Responses Standard Error 0.83
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	-0.2 Responses Standard Error 0.92
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	-2.0 Responses Standard Error 0.83
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	-1.9 Responses Standard Error 0.75

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Paracetamol/ Caffeine Tablet n=71 Participants Participants were orally administered with 200 mL solution of two soluble tablets, each tablet containing 500 mg paracetamol and 65 mg of caffeine.	Paracetamol Powder n=71 Participants Participants were orally administered with 200 mL solution of 1000 mg paracetamol soluble powder.
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	0.2 Score on a scale Standard Error 0.12
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	0.1 Score on a scale Standard Error 0.13
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	0.2 Score on a scale Standard Error 0.08
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	0.4 Score on a scale Standard Error 0.08
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 0.10	0.4 Score on a scale Standard Error 0.10
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 0.10	0.6 Score on a scale Standard Error 0.10

Adverse Events

Paracetamol/Caffeine Tablet

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Paracetamol Powder

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