Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01686646
Other study ID # RH01361
Secondary ID
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


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
See also
  Status Clinical Trial Phase
Completed NCT05269290 - Efficacy and Safety of Ingavirin®, Syrup, 30 mg/5 ml, in Children With Influenza and Other Acute Respiratory Viral Infections Phase 3
Completed NCT02451163 - DBRCT on the Effect of Wheat Polysaccharides on Common Cold Infections in Elderly Phase 2
Completed NCT01944631 - Iota-Carrageenan Nasal Spray in Common Cold Phase 4
Completed NCT01651715 - Efficacy and Safety Study of Homeopathic Oral Antibodies to Treat Viral Upper Respiratory Tract Infections Phase 1/Phase 2
Completed NCT00963443 - Acetylsalicylic Acid Combined With Pseudoephedrine in Common Cold Phase 3
Completed NCT00778648 - Encapsulated Juice Powder Concentrate for Preventing Common Cold Symptoms N/A
Completed NCT00065715 - Echinacea Versus Placebo Effect in Common Cold (Physician Echinacea Placebo) Phase 3
Completed NCT00032500 - Evaluation of Echinacea for the Common Cold Phase 2
Not yet recruiting NCT05070650 - Efficacy and Safety of the Combination of Acetylcysteine, Paracetamol and Phenylephrine for the Treatment of Common Cold Phase 3
Completed NCT04144491 - Effect of L. Rhamnosus Yoba on RTI and Other Health Outcomes Among Children (3-6 Years) in Uganda N/A
Not yet recruiting NCT04073511 - Herbal Medicine 'Eungyosan' and 'Samsoeum' for Common Cold N/A
Completed NCT03189537 - Study of Post-Exposure Ingavirin® Prophylaxis of Influenza and Acute Respiratory Viral Infections Phase 3
Terminated NCT01964885 - Benefit and Tolerability of IQP-AS-105 in Reducing Susceptibility to Upper Respiratory Tract Infections Phase 3
Completed NCT01277081 - Effect of Paracetamol on the Common Cold Phase 2
Completed NCT01728090 - Effectiveness of a Handwashing Programme in the Prevention of School Absenteeism Due to Respiratory Infections Phase 4
Completed NCT00405509 - The Natural History of Viral Upper Respiratory Infections in Children Aged 6 to Less Than 14 Years N/A
Completed NCT01033526 - Symptomatic Treatment of Common Cold Symptoms Phase 4
Completed NCT05556148 - Otrivine: Quality of Life (QoL) Impact in a Real-World Setting Phase 4
Terminated NCT03339726 - Randomized, Double-blind, Placebo-Controlled, Efficacy Study of a New Formulation of Phenylephrine HCL in the Common Cold Phase 2
Completed NCT01361399 - Active and Placebo Controlled Study to Test the Efficacy and Safety of an Aspirin-Lidocaine Lozenge in the Symptomatic Treatment of Sore Throat Associated With a Common Cold Phase 3