- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01466348
Effects of a Common Cold Treatment on Cognitive Function
September 25, 2013 updated by: GlaxoSmithKline
A reduction in alertness and lower levels of performance are commonly associated with the common cold.
Paracetamol has been shown to be more effective than placebo in treating symptoms associated with upper respiratory tract infection; caffeine has been shown to increase levels of alertness and improve performance of people suffering from colds.
This study will investigate any improvement in alertness and performance based on cognitive function and mood assessment in subjects suffering from the common cold, when taking a novel paracetamol and caffeine combination verses paracetamol alone.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
72
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Wales
-
Cardiff, Wales, United Kingdom
- Common Cold Centre
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Present with symptoms of the common cold of no more than 96 hours duration
- Score of "2" or more on a self-rating for malaise and at least 4 other cold symptoms
Exclusion Criteria:
- Pregnancy or lactation
- Hypersensitivity to drugs
- Have taken caffeine in the last 12 hours or treated their cold
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Paracetamol and Caffeine
Paracetamol and caffeine
|
Paracetamol 1000 mg and caffeine 130 mg
|
ACTIVE_COMPARATOR: Paracetamol
|
Paracetamol 1000 mg
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adjusted Mean Change From Baseline in Number of Valid Responses to Rapid Visual Information Processing (RVIP) Cognitive Test
Time Frame: Baseline to 30 minutes post treatment administration
|
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.
|
Baseline to 30 minutes post treatment administration
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adjusted Mean Change From Baseline in Number of Valid Responses to RVIP Cognitive Test
Time Frame: Baseline to 60 minutes post treatment administration
|
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.
|
Baseline to 60 minutes post treatment administration
|
Adjusted Mean Change in Baseline in Valid Reaction Time to RVIP Cognitive Test
Time Frame: Baseline, 30 minutes and up to 60 minutes post treatment administration
|
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.
|
Baseline, 30 minutes and up to 60 minutes post treatment administration
|
Mean Change From Baseline in Number of Incorrect and Missed Responses to RVIP Cognitive Test
Time Frame: Baseline, 30 minutes and up to 60 minutes post treatment administration
|
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.
|
Baseline, 30 minutes and up to 60 minutes post treatment administration
|
Adjusted Mean Change From Baseline in Number of Valid Responses to Sustained Attention Tasks (SAT) Cognitive Test
Time Frame: Baseline, 30 minutes and up to 60 minutes post treatment administration
|
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.
|
Baseline, 30 minutes and up to 60 minutes post treatment administration
|
Mean Change From Baseline in Number of Incorrect and Missed Responses to SAT Cognitive Test
Time Frame: Baseline, 30 minutes and up to 60 minutes post treatment administration
|
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.
|
Baseline, 30 minutes and up to 60 minutes post treatment administration
|
Adjusted Mean Change From Baseline in Valid Reaction Time to SAT Cognitive Test
Time Frame: Baseline, 30 minutes and up to 60 minutes post treatment administration
|
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.
|
Baseline, 30 minutes and up to 60 minutes post treatment administration
|
Adjusted Mean Change From Baseline in Number of Valid Responses to Divided Attention Task (DAT) Cognitive Test
Time Frame: Baseline, 30 minutes and up to 60 minutes post treatment administration
|
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.
|
Baseline, 30 minutes and up to 60 minutes post treatment administration
|
Adjusted Mean Change From Baseline in Valid Reaction Time to DAT Cognitive Test
Time Frame: Baseline, 30 minutes and up to 60 minutes post treatment administration
|
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.
|
Baseline, 30 minutes and up to 60 minutes post treatment administration
|
Mean Change From Baseline in Number of Incorrect and Missed Responses to DAT Cognitive Test
Time Frame: Baseline, 30 minutes and up to 60 minutes post treatment administration
|
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.
|
Baseline, 30 minutes and up to 60 minutes post treatment administration
|
Adjusted Mean Change From Baseline in Mood Alertness and Physical Sensation Scales (MAPSS) Cognitive Test
Time Frame: Baseline, 30 minutes and up to 60 minutes post treatment administration
|
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.
|
Baseline, 30 minutes and up to 60 minutes post treatment administration
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2011
Primary Completion (ACTUAL)
April 1, 2011
Study Completion (ACTUAL)
April 1, 2011
Study Registration Dates
First Submitted
November 3, 2011
First Submitted That Met QC Criteria
November 3, 2011
First Posted (ESTIMATE)
November 6, 2011
Study Record Updates
Last Update Posted (ESTIMATE)
November 25, 2013
Last Update Submitted That Met QC Criteria
September 25, 2013
Last Verified
September 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Picornaviridae Infections
- Common Cold
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Analgesics, Non-Narcotic
- Antipyretics
- Purinergic Antagonists
- Purinergic Agents
- Phosphodiesterase Inhibitors
- Purinergic P1 Receptor Antagonists
- Central Nervous System Stimulants
- Acetaminophen
- Caffeine
Other Study ID Numbers
- C6930943
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Common Cold
-
Cardiff UniversityCompletedCommon Cold/FluUnited Kingdom
-
Perrigo CompanyGlaxoSmithKline; Pfizer; McNeil Consumer Healthcare Division of McNEIL-PPC, Inc. and other collaboratorsCompletedNasal Congestion Associated With the Common ColdUnited States
-
NovartisCompletedCommon Cold Associated With CoughCanada
-
Probi ABCompletedAcute Upper Respiratory Tract Infections (Common Cold)Italy
-
Ache Laboratorios Farmaceuticos S.A.Suspended
-
Beijing Da-an Bio-technology Co., Ltd.Unknown
-
Brainfarma Industria Química e Farmacêutica S/ATechtrials Pesquisa e Tecnologia Ltda; PharmagenixUnknown
-
NovartisCompletedSore Throat Due to a Common ColdGermany
-
Boehringer IngelheimCompleted
-
Lund UniversityCoradil ABEnrolling by invitation
Clinical Trials on Paracetamol and Caffeine
-
GlaxoSmithKlineCompleted
-
GlaxoSmithKlineTerminated
-
King Faisal Specialist Hospital & Research CenterCompletedPharmacokinetics | Placebo Effect | Drug Half LifeSaudi Arabia
-
GlaxoSmithKlineTerminatedHeadache, Tension-TypeUnited States
-
GlaxoSmithKlineCompleted
-
University of HelsinkiFoundation for Paediatric Research, FinlandCompleted
-
Southern Illinois University CarbondaleCompleted
-
GlaxoSmithKlineCompleted
-
Sharp HealthCareCompletedCaffeineUnited States