Common ColdPhase 3NCT01686646

Effects of Two Doses of a Common Cold Treatment on Alertness

A Phase 3 study testing paracetamol + caffeine and paracetamol in people with Common Cold, run by GlaxoSmithKline at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. 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 + caffeine and paracetamol
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 240 participants
Where: 1 siteUnited Kingdom
Study dates: Nov 2011to Nov 2012
Phase: Phase 3
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

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.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Common Cold Centre
Cardiff, Wales

Other trials in United Kingdom

About this study

Official title: Effects of Two Doses of a Common Cold Treatment on Cognitive Function

Conditions: Common Cold
Being tested: paracetamol + caffeine, paracetamol
Keywords: alertness
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 + caffeineDrug
paracetamol with caffeine
paracetamolDrug
paracetamol

Study groups in NCT01686646
Study group	Role	What they receive
highest dose Paracetamol + caffeine	Active comparator	highest dose of Paracetamol and caffeine Receives: Drug: paracetamol + caffeine
low-dose Paracetamol + caffeine	Active comparator	lowest dose of Paracetamol and caffeine Receives: Drug: paracetamol + caffeine
high dose paracetamol	Active comparator	highest dose paracetamol Receives: Drug: paracetamol
low dose paracetamol	Active comparator	lowest dose paracetamol Receives: Drug: paracetamol

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline to 60 minutes post treatment administration

Secondary outcomes (9)

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.
Measured: Baseline to 120 minutes post treatment administration
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).
Measured: Baseline, 60 minutes and upto 120 minutes post treatment administration
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.
Measured: Baseline, 60 minutes and up to 120 minutes post treatment administration
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'.
Measured: Baseline, 60 minutes and up to 120 minutes post treatment administration
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).
Measured: Baseline, 30 minutes and up to 60 minutes post treatment administration
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.
Measured: Baseline, 60 minutes and up to 120 minutes post treatment administration
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'.
Measured: Baseline, 60 minutes and up to 120 minutes post treatment administration
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).
Measured: Baseline, 60 minutes and up to 120 minutes post treatment administration
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.
Measured: Baseline, 60 minutes and up to 120 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.

Nov 2011Nov 2012

First posted18 Sep 2012 (estimated)
Study startNov 2011
Primary completionNov 2012
Study completionNov 2012

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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 240 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01686646
Sponsor's protocol ID: RH01361
Status last verified: Jul 2014
First submitted: 13 Sep 2012
Last updated: 8 Dec 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Common Cold trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Two Doses of a Common Cold Treatment on Cognitive Function
ClinicalTrials.gov ID: NCT01686646
Acronym / sponsor ID: RH01361
Conditions: Common Cold
Keywords: alertness
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 240 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: Nov 2011
Primary completion: Nov 2012 (actual)
Study completion: Nov 2012 (actual)
First posted: 18 Sep 2012 (estimated)
Results: Posted 14 Jul 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
highest dose Paracetamol + caffeine	Active comparator	Drug: paracetamol + caffeinehighest dose of Paracetamol and caffeine
low-dose Paracetamol + caffeine	Active comparator	Drug: paracetamol + caffeinelowest dose of Paracetamol and caffeine
high dose paracetamol	Active comparator	Drug: paracetamolhighest dose paracetamol
low dose paracetamol	Active comparator	Drug: paracetamollowest dose paracetamol

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

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 + caffeineparacetamol with caffeine	Drug	highest dose Paracetamol + caffeine, low-dose Paracetamol + caffeine
paracetamolparacetamol	Drug	high dose paracetamol, low dose paracetamol

Primary outcome

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

9 secondary outcomes

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

Results and safety

Results posted to the registry on 14 Jul 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Paracetamol + Caffeine Combination (1000/130)	45	45
Paracetamol (1000)	45	45
Paracetamol + Caffeine Combination (500/65)	75	75
Paracetamol (500)	75	75

Primary outcome: Change From Baseline in Number of Accurate Responses to Rapid Visual Information Processing (RVIP) Cognitive Test

Time frame: Baseline to 60 minutes post treatment administration. Least squares mean (Standard Error). Unit: Correct responses

Measure	Paracetamol + Caffeine Combination (1000/130) n = 45	Paracetamol (1000) n = 45	Paracetamol + Caffeine Combination (500/65) n = 75	Paracetamol (500) n = 75
Value	8.3 (1.12)	4.8 (1.12)	4.5 (0.89)	2.7 (0.88)

Paracetamol + Caffeine Combination (1000/130) vs Paracetamol (1000): LS Mean DIfference: 3.5 (95% CI 0.4 to 6.5), p = 0.0248, ANCOVA
Paracetamol + Caffeine Combination (500/65) vs Paracetamol (500): LS Mean Difference: 1.7 (95% CI -0.6 to 4.1), p = 0.1513, ANCOVA
Paracetamol + Caffeine Combination (1000/130) vs Paracetamol + Caffeine Combination (500/65): LS Mean Difference: 3.9 (95% CI 1.1 to 6.6), ANCOVA

Population analysed: Intent to Treat (ITT) population: all randomized participants who received study treatment and had at least one post-baseline efficacy evaluation.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected from the start of the treatment, and until 5 days following administration of the last dose of investigational product.. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Paracetamol + Caffeine Combination (1000/130)	0 of 46 (0%)	0 of 46 (0%)	Not reported
Paracetamol (1000)	0 of 45 (0%)	0 of 45 (0%)	Not reported
Paracetamol + Caffeine Combination (500/65)	0 of 74 (0%)	0 of 74 (0%)	Not reported
Paracetamol (500)	0 of 75 (0%)	0 of 75 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Common Cold

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Not yet recruitingObservational study
Post-market Clinical Follow-up Study of an Isotonic Saline Solution for the Relief of Nasal Congestion in Infants and Toddlers
Nasal Congestion, Common Cold
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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 3 study testing paracetamol + 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?

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 8 Dec 2014. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 14 Jul 2014). 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?

Change From Baseline in Number of Accurate Responses to Rapid Visual Information Processing (RVIP) Cognitive Test (time frame: Baseline to 60 minutes post treatment administration). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01686646.

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 8 Dec 2014.