Common ColdPhase 4NCT01466348
Effects of a Common Cold Treatment on Cognitive Function
A Phase 4 study testing Paracetamol and Caffeine and Paracetamol in people with Common Cold, run by GlaxoSmithKline at 1 site in United Kingdom.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Common Cold
- What is being tested?
- Paracetamol and Caffeine and Paracetamol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2011to Apr 2011
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnancy or lactation
- Hypersensitivity to drugs
- Have taken caffeine in the last 12 hours or treated their cold
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Common Cold
- Being tested
- Paracetamol and Caffeine, Paracetamol
- Keywords
- Paracetomol, Caffeine, Common cold
- Medical subject headings
- Common Cold
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paracetamol and CaffeineDrug
Paracetamol 1000 mg and caffeine 130 mg
ParacetamolDrug
Paracetamol 1000 mg
| Study group | Role | What they receive |
|---|---|---|
| Paracetamol and Caffeine | Experimental | Paracetamol and caffeine Receives: Drug: Paracetamol and Caffeine |
| Paracetamol | Active comparator | Paracetamol Receives: Drug: Paracetamol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adjusted Mean Change From Baseline in Number of Valid 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. 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.
Measured: Baseline to 30 minutes post treatment administration
Secondary outcomes (10)
Adjusted Mean Change From Baseline in Number of Valid Responses to RVIP Cognitive Test
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.
Measured: Baseline to 60 minutes post treatment administration
Adjusted Mean Change in Baseline in Valid Reaction Time to RVIP Cognitive Test
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: Baseline, 30 minutes and up to 60 minutes post treatment administration
Adjusted Mean Change From Baseline in Valid Reaction Time to SAT Cognitive Test
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.
Measured: 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
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.
Measured: Baseline, 30 minutes and up to 60 minutes post treatment administration
Adjusted Mean Change From Baseline in Valid Reaction Time to DAT Cognitive Test
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.
Measured: 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
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.
Measured: 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
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.
Measured: Baseline, 30 minutes and up to 60 minutes post treatment administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2011 (estimated)
- Study startFeb 2011
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Common ColdStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01466348
- Sponsor's protocol ID
- C6930943
- Status last verified
- Sep 2013
- First submitted
- 3 Nov 2011
- Last updated
- 25 Nov 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Common Cold Treatment on Cognitive Function
- ClinicalTrials.gov ID
- NCT01466348
- Acronym / sponsor ID
- C6930943
- Conditions
- Common Cold
- Keywords
- Paracetomol, Caffeine, Common cold
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 7 Nov 2011 (estimated)
- Results
- Posted 25 Nov 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paracetamol and Caffeine | Experimental | Drug: Paracetamol and CaffeineParacetamol and caffeine |
| Paracetamol | Active comparator | Drug: ParacetamolParacetamol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- Pregnancy or lactation
- Hypersensitivity to drugs
- Have taken caffeine in the last 12 hours or treated their cold
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paracetamol and CaffeineParacetamol 1000 mg and caffeine 130 mg | Drug | Paracetamol and Caffeine |
| ParacetamolParacetamol 1000 mg | Drug | Paracetamol |
Primary outcome
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.
10 secondary outcomes
Adjusted Mean Change From Baseline in Number of Valid Responses to RVIP Cognitive Test
Time frame: 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
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
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
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
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
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
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
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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Omega-Cold Supplementation With Free Fatty Acids for the Prevention of Respiratory Infections in Adults.
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Safety and Performance Assessment of the Decongestant Seawater Spray Pocket Valve Enriched With Essential Oils in Patients With Acute Rhinitis Associated With Nasal Obstruction: "DEVALPO"
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Paracetamol and Caffeine and Paracetamol in people with Common Cold, run by GlaxoSmithKline at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Nov 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2013.