Effects of Two Doses of a Common Cold Treatment on Alertness

Common Cold Clinical Trial

Official title:

Effects of Two Doses of a Common Cold Treatment on Cognitive Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01686646
• Other study ID #: RH01361
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2012
• Last updated: November 20, 2014
• Start date: November 2011
• Est. completion date: November 2012

Study information

• Verified date: July 2014
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

• Participants with symptoms of cold < 96 hours, rating of at least '2' on malaise at least 4 other symptoms of cold.

• No history of clinically significant perennial rhinitis, no recent antibiotic, antihistamine or cold treatment, no caffeine in the previous 12 hours, no psychoactive medication in the 14 days prior to screening, no pregnancy, breastfeeding or participation in this trial, or another trial in the 30 days prior to screening.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Common Cold

Intervention

Drug:
• paracetamol + caffeine
paracetamol with caffeine
• paracetamol
paracetamol

Locations

Country	Name	City	State
United Kingdom	Common Cold Centre	Cardiff	Wales

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Number of Accurate 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. 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.	Baseline to 60 minutes post treatment administration	No
Secondary	Change From Baseline in Number of Accurate Responses to RVIP Cognitive Test	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.	Baseline to 120 minutes post treatment administration	No
Secondary	Change From Baseline in Mean Time of Accurate Responses to RVIP Cognitive Task	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).	Baseline, 60 minutes and upto 120 minutes post treatment administration	No
Secondary	Change From Baseline in Number of Inaccurate and Missed Responses to RVIP Cognitive Task	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.	Baseline, 60 minutes and up to 120 minutes post treatment administration	No
Secondary	Change From Baseline in Number of Accurate 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 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'.	Baseline, 60 minutes and up to 120 minutes post treatment administration	No
Secondary	Change From Baseline in Mean Time of Accurate Responses to SAT Cognitive Task	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).	Baseline, 30 minutes and up to 60 minutes post treatment administration	No
Secondary	Change From Baseline in Number of Incorrect and Missed Responses to SAT Cognitive Test	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.	Baseline, 60 minutes and up to 120 minutes post treatment administration	No
Secondary	Change From Baseline in Number of Valid Responses to Divided Attention Task (DAT) Cognitive Test	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'.	Baseline, 60 minutes and up to 120 minutes post treatment administration	No
Secondary	Change From Baseline in Mean Time of Accurate Responses to DAT Cognitive Test	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).	Baseline, 60 minutes and up to 120 minutes post treatment administration	No
Secondary	Change From Baseline in Number of Incorrect and Missed Responses to DAT Cognitive Test	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.	Baseline, 60 minutes and up to 120 minutes post treatment administration	No