Effects of Two Doses of a Common Cold Treatment on Alertness

Phase 3

Completed

• Conditions: Common Cold
• Interventions: Drug: paracetamol; Drug: paracetamol + caffeine

• Registration Number: NCT01686646
• Lead Sponsor: GlaxoSmithKline

Brief Summary

This study will investigate any improvement in alertness and performance based on cognitive function and mood assessment in subjects suffering the common cold, when taking a novel paracetamol and caffeine combination verses paracetamol alone.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2012-09-13
• Study First Submitted QC: 2012-09-17
• Study First Posted: 2012-09-18
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Results First Submitted: 2013-08-29
• Status Verified: 2014-07
• Results First Submitted QC: 2014-07-10
• Results First Posted: 2014-07-14
• Last Update Submitted: 2014-11-20
• Last Update Posted: 2014-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
low dose paracetamol	paracetamol	lowest dose paracetamol
high dose paracetamol	paracetamol	highest dose paracetamol
highest dose Paracetamol + caffeine	paracetamol + caffeine	highest dose of Paracetamol and caffeine
low-dose Paracetamol + caffeine	paracetamol + caffeine	lowest dose of Paracetamol and caffeine

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Number of Accurate Responses to Rapid Visual Information Processing (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. 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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Number of Accurate Responses to RVIP Cognitive Test	Baseline to 120 minutes post treatment administration	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.
Change From Baseline in Mean Time of Accurate Responses to RVIP Cognitive Task	Baseline, 60 minutes and upto 120 minutes post treatment administration	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).
Change From Baseline in Number of Inaccurate and Missed Responses to RVIP Cognitive Task	Baseline, 60 minutes and up to 120 minutes post treatment administration	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.
Change From Baseline in Number of Accurate Responses to Sustained Attention Tasks (SAT) Cognitive Test	Baseline, 60 minutes and up to 120 minutes post treatment administration	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'.
Change From Baseline in Mean Time of Accurate Responses to SAT Cognitive Task	Baseline, 30 minutes and up to 60 minutes post treatment administration	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).
Change From Baseline in Number of Incorrect and Missed Responses to SAT Cognitive Test	Baseline, 60 minutes and up to 120 minutes post treatment administration	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.
Change From Baseline in Number of Valid Responses to Divided Attention Task (DAT) Cognitive Test	Baseline, 60 minutes and up to 120 minutes post treatment administration	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'.
Change From Baseline in Mean Time of Accurate Responses to DAT Cognitive Test	Baseline, 60 minutes and up to 120 minutes post treatment administration	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).
Change From Baseline in Number of Incorrect and Missed Responses to DAT Cognitive Test	Baseline, 60 minutes and up to 120 minutes post treatment administration	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.

Trial Locations

Locations (1)

Common Cold Centre; 🇬🇧 Cardiff, Wales, United Kingdom