Trial · NCT01686646
Effects of Two Doses of a Common Cold Treatment on Alertness
NCT01686646, Phase 3, Completed, GlaxoSmithKline; results first posted 2014-07-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Effects of Two Doses of a Common Cold Treatment on Alertness. Trials, record NCT01686646. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01686646
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effects of Two Doses of a Common Cold Treatment on Alertness
- NCT number
- NCT01686646
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 240 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Common Cold
- Interventions
- paracetamol + caffeine, paracetamol
- First posted
- 2012-09-18
- Last updated
- 2014-12-08
- Results first posted
- 2014-07-14
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Number of Accurate Responses to Rapid Visual Information Processing (RVIP) Cognitive Test | 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. |
| Secondary | Change From Baseline in Number of Accurate Responses to RVIP Cognitive Test | Baseline to 120 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. |
| Secondary | Change From Baseline in Mean Time of Accurate Responses to RVIP Cognitive Task | Baseline, 60 minutes and upto 120 minutes post treatment administration | 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). |
| Secondary | Change From Baseline in Number of Inaccurate and Missed Responses to RVIP Cognitive Task | Baseline, 60 minutes and up to 120 minutes post treatment administration | 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. |
| Secondary | Change From Baseline in Number of Accurate Responses to Sustained Attention Tasks (SAT) Cognitive Test | Baseline, 60 minutes and up to 120 minutes post treatment administration | 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'. |
| Secondary | Change From Baseline in Mean Time of Accurate Responses to SAT Cognitive Task | Baseline, 30 minutes and up to 60 minutes post treatment administration | 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). |
| Secondary | Change From Baseline in Number of Incorrect and Missed Responses to SAT Cognitive Test | Baseline, 60 minutes and up to 120 minutes post treatment administration | 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. |
| Secondary | Change From Baseline in Number of Valid Responses to Divided Attention Task (DAT) Cognitive Test | Baseline, 60 minutes and up to 120 minutes post treatment administration | 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'. |
| Secondary | Change From Baseline in Mean Time of Accurate Responses to DAT Cognitive Test | Baseline, 60 minutes and up to 120 minutes post treatment administration | 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). |
| Secondary | Change From Baseline in Number of Incorrect and Missed Responses to DAT Cognitive Test | Baseline, 60 minutes and up to 120 minutes post treatment administration | 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. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Number of Accurate Responses to Rapid Visual Information Processing (RVIP) Cognitive Test | Baseline to 60 minutes post treatment administration | Intent to Treat (ITT) population: all randomized participants who received study treatment and had at least one post-baseline efficacy evaluation. | Correct responses | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Number of Accurate Responses to RVIP Cognitive Test | Baseline to 120 minutes post treatment administration | ITT population: all randomized participants who received study treatment and had at least one post-baseline efficacy evaluation. | Correct responses | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Mean Time of Accurate Responses to RVIP Cognitive Task | Baseline, 60 minutes and upto 120 minutes post treatment administration | ITT population: all randomized participants who received study treatment and had at least one post-baseline efficacy evaluation. | milliseconds (msec) | MEDIAN |
| SECONDARY | Change From Baseline in Number of Inaccurate and Missed Responses to RVIP Cognitive Task | Baseline, 60 minutes and up to 120 minutes post treatment administration | ITT population: all randomized participants who received study treatment and had at least one post-baseline efficacy evaluation. | inaccurate and missed responses | MEAN |
| SECONDARY | Change From Baseline in Number of Accurate Responses to Sustained Attention Tasks (SAT) Cognitive Test | Baseline, 60 minutes and up to 120 minutes post treatment administration | ITT population: all randomized participants who received study treatment and had at least one post-baseline efficacy evaluation. | Correct responses | MEDIAN |
| SECONDARY | Change From Baseline in Mean Time of Accurate Responses to SAT Cognitive Task | Baseline, 30 minutes and up to 60 minutes post treatment administration | ITT population: all randomized participants who received study treatment and had at least one post-baseline efficacy evaluation. | msec | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Number of Incorrect and Missed Responses to SAT Cognitive Test | Baseline, 60 minutes and up to 120 minutes post treatment administration | ITT population: all randomized participants who received study treatment and had at least one post-baseline efficacy evaluation. | incorrect and missed responses | MEAN |
| SECONDARY | Change From Baseline in Number of Valid Responses to Divided Attention Task (DAT) Cognitive Test | Baseline, 60 minutes and up to 120 minutes post treatment administration | ITT population: all randomized participants who received study treatment and had at least one post-baseline efficacy evaluation. | Correct responses | MEDIAN |
| SECONDARY | Change From Baseline in Mean Time of Accurate Responses to DAT Cognitive Test | Baseline, 60 minutes and up to 120 minutes post treatment administration | ITT population: all randomized participants who received study treatment and had at least one post-baseline efficacy evaluation. | msec | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Number of Incorrect and Missed Responses to DAT Cognitive Test | Baseline, 60 minutes and up to 120 minutes post treatment administration | ITT population: all randomized participants who received study treatment and had at least one post-baseline efficacy evaluation. | incorrect and missed responses | MEAN |
Source ClinicalTrials.gov
Results by group96
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Number of Accurate Responses to Rapid Visual Information Processing (RVIP) Cognitive Test | Paracetamol + Caffeine Combination (1000/130) | 8.3 | Standard Error 1.12 | Correct responses | |
| Change From Baseline in Number of Accurate Responses to Rapid Visual Information Processing (RVIP) Cognitive Test | Paracetamol (1000) | 4.8 | Standard Error 1.12 | Correct responses | |
| Change From Baseline in Number of Accurate Responses to Rapid Visual Information Processing (RVIP) Cognitive Test | Paracetamol + Caffeine Combination (500/65) | 4.5 | Standard Error 0.89 | Correct responses | |
| Change From Baseline in Number of Accurate Responses to Rapid Visual Information Processing (RVIP) Cognitive Test | Paracetamol (500) | 2.7 | Standard Error 0.88 | Correct responses | |
| Change From Baseline in Number of Accurate Responses to RVIP Cognitive Test | Paracetamol + Caffeine Combination (1000/130) | 7.3 | Standard Error 1.16 | Correct responses | |
| Change From Baseline in Number of Accurate Responses to RVIP Cognitive Test | Paracetamol (1000) | 4.4 | Standard Error 1.15 | Correct responses | |
| Change From Baseline in Number of Accurate Responses to RVIP Cognitive Test | Paracetamol + Caffeine Combination (500/65) | 6.2 | Standard Error 0.91 | Correct responses | |
| Change From Baseline in Number of Accurate Responses to RVIP Cognitive Test | Paracetamol (500) | 3.5 | Standard Error 0.92 | Correct responses | |
| Change From Baseline in Mean Time of Accurate Responses to RVIP Cognitive Task | Paracetamol + Caffeine Combination (1000/130) | 60 minutes | -1.4 | Full Range -92 to 102 | milliseconds (msec) |
| Change From Baseline in Mean Time of Accurate Responses to RVIP Cognitive Task | Paracetamol (1000) | 60 minutes | 2.4 | Full Range -113 to 313 | milliseconds (msec) |
1 to 10 of 96Source ClinicalTrials.gov
See all 96 results by groupParticipant flow20
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Paracetamol + Caffeine Combination (1000/130) | 45 | |
| Overall Study | STARTED | Paracetamol (1000) | 45 | |
| Overall Study | STARTED | Paracetamol + Caffeine Combination (500/65) | 75 | |
| Overall Study | STARTED | Paracetamol (500) | 75 | |
| Overall Study | Intent to Treat Population | Paracetamol + Caffeine Combination (1000/130) | 45 | |
| Overall Study | Intent to Treat Population | Paracetamol (1000) | 45 | |
| Overall Study | Intent to Treat Population | Paracetamol + Caffeine Combination (500/65) | 75 | |
| Overall Study | Intent to Treat Population | Paracetamol (500) | 75 | |
| Overall Study | Safety Population | Paracetamol + Caffeine Combination (1000/130) | 46 | |
| Overall Study | Safety Population | Paracetamol (1000) | 45 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 participant flowAdverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Paracetamol + Caffeine Combination (1000/130) | ||
| Total, all-cause mortality | Paracetamol (1000) | ||
| Total, all-cause mortality | Paracetamol + Caffeine Combination (500/65) | ||
| Total, all-cause mortality | Paracetamol (500) | ||
| Total, other adverse events | Paracetamol + Caffeine Combination (1000/130) | 0 | 46 |
| Total, other adverse events | Paracetamol (1000) | 0 | 45 |
| Total, other adverse events | Paracetamol + Caffeine Combination (500/65) | 0 | 74 |
| Total, other adverse events | Paracetamol (500) | 0 | 75 |
| Total, serious adverse events | Paracetamol + Caffeine Combination (1000/130) | 0 | 46 |
| Total, serious adverse events | Paracetamol (1000) | 0 | 45 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests1
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as |
|---|---|
| Rapid Visual Information Processing | Primary outcome |
Source ConductCognition
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01686646
GET https://conductscience.org/api/trials/v1/NCT01686646/results?page=2