Trial · NCT01466348
Effects of a Common Cold Treatment on Cognitive Function
NCT01466348, Phase 4, Completed, GlaxoSmithKline; results first posted 2013-11-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Effects of a Common Cold Treatment on Cognitive Function. Trials, record NCT01466348. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01466348
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effects of a Common Cold Treatment on Cognitive Function
- NCT number
- NCT01466348
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 72 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Common Cold
- Interventions
- Paracetamol and Caffeine, Paracetamol
- First posted
- 2011-11-07
- Last updated
- 2013-11-25
- Results first posted
- 2013-11-25
- Limitations and caveats
Apparent carryover effect from the paracetamol/ caffeine treatment taken in Period 1 into the baseline assessment of Period 2 was observed, hence the statistical analysis was amended after unblinding the statistician.
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Adjusted Mean Change From Baseline in Number of Valid Responses to Rapid Visual Information Processing (RVIP) Cognitive Test | 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. |
| Secondary | Adjusted Mean Change From Baseline in Number of Valid Responses to 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. 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. |
| Secondary | Adjusted Mean Change in Baseline in Valid Reaction Time to RVIP Cognitive Test | 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. |
| Secondary | Mean Change From Baseline in Number of Incorrect and Missed Responses to RVIP Cognitive Test | 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. |
| Secondary | Adjusted Mean Change From Baseline in Number of Valid Responses to Sustained Attention Tasks (SAT) Cognitive Test | 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. |
| Secondary | Mean Change From Baseline in Number of Incorrect and Missed Responses to SAT Cognitive Test | 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. |
| Secondary | Adjusted Mean Change From Baseline in Valid Reaction Time to SAT Cognitive Test | 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. |
| Secondary | Adjusted Mean Change From Baseline in Number of Valid Responses to Divided Attention Task (DAT) Cognitive Test | 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. |
| Secondary | Adjusted Mean Change From Baseline in Valid Reaction Time to DAT Cognitive Test | 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. |
| Secondary | Mean Change From Baseline in Number of Incorrect and Missed Responses to DAT Cognitive Test | 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. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Adjusted Mean Change From Baseline in Number of Valid Responses to Rapid Visual Information Processing (RVIP) Cognitive Test | Baseline to 30 minutes post treatment administration | Intent-To-Treat (ITT) population: All randomized participants who were randomized and had at least one post-baseline efficacy evaluation. | Valid responses | MEAN |
| SECONDARY | Adjusted Mean Change From Baseline in Number of Valid Responses to RVIP Cognitive Test | Baseline to 60 minutes post treatment administration | ITT population: All randomized participants who were randomized and had at least one post-baseline efficacy evaluation. | Valid responses | MEAN |
| SECONDARY | Adjusted Mean Change in Baseline in Valid Reaction Time to RVIP Cognitive Test | Baseline, 30 minutes and up to 60 minutes post treatment administration | ITT population: All randomized participants who were randomized and had at least one post-baseline efficacy evaluation. | milliseconds (msec) | MEAN |
| SECONDARY | Mean Change From Baseline in Number of Incorrect and Missed Responses to RVIP Cognitive Test | Baseline, 30 minutes and up to 60 minutes post treatment administration | ITT population: All randomized participants who were randomized and had at least one post-baseline efficacy evaluation. | Responses | MEAN |
| SECONDARY | Adjusted Mean Change From Baseline in Number of Valid Responses to Sustained Attention Tasks (SAT) Cognitive Test | Baseline, 30 minutes and up to 60 minutes post treatment administration | ITT population: All randomized participants who were randomized and had at least one post-baseline efficacy evaluation. | Valid responses | MEAN |
| SECONDARY | Mean Change From Baseline in Number of Incorrect and Missed Responses to SAT Cognitive Test | Baseline, 30 minutes and up to 60 minutes post treatment administration | ITT population: All randomized participants who were randomized and had at least one post-baseline efficacy evaluation. | Responses | MEAN |
| SECONDARY | Adjusted Mean Change From Baseline in Valid Reaction Time to SAT Cognitive Test | Baseline, 30 minutes and up to 60 minutes post treatment administration | ITT population: All randomized participants who were randomized and had at least one post-baseline efficacy evaluation. | msec | MEAN |
| SECONDARY | Adjusted Mean Change From Baseline in Number of Valid Responses to Divided Attention Task (DAT) Cognitive Test | Baseline, 30 minutes and up to 60 minutes post treatment administration | ITT population: All randomized participants who were randomized and had at least one post-baseline efficacy evaluation. | Valid responses | MEAN |
| SECONDARY | Adjusted Mean Change From Baseline in Valid Reaction Time to DAT Cognitive Test | Baseline, 30 minutes and up to 60 minutes post treatment administration | ITT population: All randomized participants who were randomized and had at least one post-baseline efficacy evaluation. | msec | MEAN |
| SECONDARY | Mean Change From Baseline in Number of Incorrect and Missed Responses to DAT Cognitive Test | Baseline, 30 minutes and up to 60 minutes post treatment administration | ITT population: All randomized participants who were randomized and had at least one post-baseline efficacy evaluation. | Responses | MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group60
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Adjusted Mean Change From Baseline in Number of Valid Responses to Rapid Visual Information Processing (RVIP) Cognitive Test | Paracetamol/ Caffeine Tablet | 4.8 | Standard Deviation 0.80 | Valid responses | |
| Adjusted Mean Change From Baseline in Number of Valid Responses to Rapid Visual Information Processing (RVIP) Cognitive Test | Paracetamol Powder | 1.3 | Standard Deviation 0.80 | Valid responses | |
| Adjusted Mean Change From Baseline in Number of Valid Responses to RVIP Cognitive Test | Paracetamol/ Caffeine Tablet | 7.1 | Standard Deviation 0.93 | Valid responses | |
| Adjusted Mean Change From Baseline in Number of Valid Responses to RVIP Cognitive Test | Paracetamol Powder | 0.6 | Standard Deviation 0.93 | Valid responses | |
| Adjusted Mean Change in Baseline in Valid Reaction Time to RVIP Cognitive Test | Paracetamol/ Caffeine Tablet | 30 minutes | 6.00 | Standard Error 3.916 | milliseconds (msec) |
| Adjusted Mean Change in Baseline in Valid Reaction Time to RVIP Cognitive Test | Paracetamol Powder | 30 minutes | 1.88 | Standard Error 3.916 | milliseconds (msec) |
| Adjusted Mean Change in Baseline in Valid Reaction Time to RVIP Cognitive Test | Paracetamol/ Caffeine Tablet | 60 minutes | 0.08 | Standard Error 3.983 | milliseconds (msec) |
| Adjusted Mean Change in Baseline in Valid Reaction Time to RVIP Cognitive Test | Paracetamol Powder | 60 minutes | -4.85 | Standard Error 3.954 | milliseconds (msec) |
| Mean Change From Baseline in Number of Incorrect and Missed Responses to RVIP Cognitive Test | Paracetamol/ Caffeine Tablet | Incorrect responses at 30 minutes | -2.3 | Standard Error 1.57 | Responses |
| Mean Change From Baseline in Number of Incorrect and Missed Responses to RVIP Cognitive Test | Paracetamol Powder | Incorrect responses at 30 minutes | -2.7 | Standard Error 1.52 | Responses |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 results by groupParticipant flow14
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Period I - First Intervention | STARTED | Paracetamol/ Caffeine Tablet Then Paracetamol Powder | 36 | |
| Period I - First Intervention | STARTED | Paracetamol Powder Then Paracetamol/ Caffeine Tablet | 36 | |
| Period I - First Intervention | Intent To Treat (ITT) Population | Paracetamol/ Caffeine Tablet Then Paracetamol Powder | 36 | |
| Period I - First Intervention | Intent To Treat (ITT) Population | Paracetamol Powder Then Paracetamol/ Caffeine Tablet | 35 | |
| Period I - First Intervention | COMPLETED | Paracetamol/ Caffeine Tablet Then Paracetamol Powder | 36 | |
| Period I - First Intervention | COMPLETED | Paracetamol Powder Then Paracetamol/ Caffeine Tablet | 35 | |
| Period I - First Intervention | NOT COMPLETED | Paracetamol/ Caffeine Tablet Then Paracetamol Powder | 0 | |
| Period I - First Intervention | NOT COMPLETED | Paracetamol Powder Then Paracetamol/ Caffeine Tablet | 1 | |
| Period II - Second Intervention | STARTED | Paracetamol/ Caffeine Tablet Then Paracetamol Powder | 35 | |
| Period II - Second Intervention | STARTED | Paracetamol Powder Then Paracetamol/ Caffeine Tablet | 36 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 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 totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Paracetamol/Caffeine Tablet | ||
| Total, all-cause mortality | Paracetamol Powder | ||
| Total, other adverse events | Paracetamol/Caffeine Tablet | 0 | 71 |
| Total, other adverse events | Paracetamol Powder | 0 | 71 |
| Total, serious adverse events | Paracetamol/Caffeine Tablet | 0 | 71 |
| Total, serious adverse events | Paracetamol Powder | 0 | 71 |
Source ClinicalTrials.gov
Papers0
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Paracetamol/Caffeine Tablet vs Paracetamol Powder: serious adverse events |
Source Trial comparisons
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/NCT01466348
GET https://conductscience.org/api/trials/v1/NCT01466348/results?page=2