Trial · NCT01277081
Effect of Paracetamol on the Common Cold
NCT01277081, Phase 2, Completed, GlaxoSmithKline; results first posted 2015-02-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effect of Paracetamol on the Common Cold. Trials, record NCT01277081. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01277081
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effect of Paracetamol on the Common Cold
- NCT number
- NCT01277081
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 200 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Common Cold
- Interventions
- Paracetamol hot drink, Paracetamol tablets
- First posted
- 2011-01-14
- Last updated
- 2015-02-18
- Results first posted
- 2015-02-18
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Breathing Scores Post 15 Minutes | Baseline to 15 minutes | A mean breathing score was calculated at baseline, 30 seconds, 2, 5 and 15 minutes, derived from participant responses to questions relating to breathing i.e. "my breathing feels easy", "I feel airways are open", "I feel a cooling sensation in my throat", "I can feel the air flowing to my lungs easily", "My nose feels less blocked" and "I feel my breathing is comfortable". The breathing scores were rated by the participants on a 5 point (0-4) rating scale with '0' being labeled as 'strongly disagree' and '4' being labeled as 'strongly agree'. For each participant, a mean score was derived by summing the responses and dividing by the number of questions answered. |
| Secondary | Breathing Score Post 60 Minutes | Baseline to 60 minutes | A mean breathing score was calculated at baseline, 30 seconds, 2, 5, 15 and 60 minutes, derived from participant responses to questions relating to breathing i.e. "my breathing feels easy", "I feel airways are open", "I feel a cooling sensation in my throat", "I can feel the air flowing to my lungs easily", "My nose feels less blocked" and "I feel my breathing is comfortable". The breathing scores were rated by the participants on a 5 point (0-4) rating scale with '0' being labeled as 'strongly disagree' and '4' being labeled as 'strongly agree'. For each participant, a mean score was derived by summing the responses and dividing by the number of questions answered. |
| Secondary | Cold Symptoms Score Post 15 Minutes | Baseline to 15 minutes | A mean Cold symptom score was calculated at baseline, 30 seconds, 2, 5 and 15 minutes from participant responses to questions relating to cold symptoms i.e. "My head feels clear", "I feel soothing in my throat" and "I feel my cough is being soothed". The cold symptom scores were rated by the participants on a 5 point (0-4) rating scale with '0' being labeled as 'strongly disagree' and '4' being labeled as 'strongly agree'. For each participant, a mean score was derived by summing the responses and dividing by the number of questions answered. |
| Secondary | Cold Symptoms Score Post 60 Minutes | Baseline to 60 minutes | A mean Cold symptom score was calculated at baseline, 30 seconds, 2, 5, 15 and 60 minutes from participant responses to questions relating to cold symptoms i.e. "My head feels clear", "I feel soothing in my throat" and "I feel my cough is being soothed". The cold symptom scores were rated by the participants on a 5 point (0-4) rating scale with '0' being labeled as 'strongly disagree' and '4' being labeled as 'strongly agree'. For each participant, a mean score was derived by summing the responses and dividing by the number of questions answered. |
| Secondary | Soothing Attribute Scores | Baseline to 15 and 60 minutes | Soothing attribute of test treatment was assessed by asking the question "if the hot drink is soothing" at baseline, 15 and 60 minutes. The response to the question was rated by participants on a 5 point (0-4) rating scale with '0' being labeled as 'strongly disagree' and '4' being labeled as 'strongly agree'. |
| Secondary | Overall Cold Symptoms Score | Baseline to 15 and 60 minutes | Overall cold symptom score was assessed by asking the question "my cold symptoms are improved" only post consuming the drink at baseline, 15 and 60 minutes . The response to the question was rated by participants on a 5 point (0-4) rating scale with '0' being labeled as 'strongly disagree' and '4' being labeled as 'strongly agree'. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Breathing Scores Post 15 Minutes | Baseline to 15 minutes | Intent to Treat (ITT) Population: All randomized participants who had at least one post-baseline efficacy evaluation. | Score on a Scale | MEAN |
| SECONDARY | Breathing Score Post 60 Minutes | Baseline to 60 minutes | ITT population: All randomized participants who had at least one post-baseline efficacy evaluation. | Score on a scale | MEAN |
| SECONDARY | Cold Symptoms Score Post 15 Minutes | Baseline to 15 minutes | ITT Population: all randomized participants who had at least one post-baseline efficacy evaluation. | Score on a scale | MEAN |
| SECONDARY | Cold Symptoms Score Post 60 Minutes | Baseline to 60 minutes | ITT population: all randomized participants who had at least one post-baseline efficacy evaluation. | Score on a scale | MEAN |
| SECONDARY | Soothing Attribute Scores | Baseline to 15 and 60 minutes | ITT population: all randomized participants who had at least one post-baseline efficacy evaluation. | Score on a scale | MEAN |
| SECONDARY | Overall Cold Symptoms Score | Baseline to 15 and 60 minutes | ITT population: all randomized participants who had at least one post-baseline efficacy evaluation. | Score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Breathing Scores Post 15 Minutes | Mentholated Paracetamol Hot Drink | 0.83 | 95% Confidence Interval 0.73 to 0.93 | Score on a Scale | |
| Breathing Scores Post 15 Minutes | Paracetamol Tablet | 0.11 | 95% Confidence Interval 0.01 to 0.21 | Score on a Scale | |
| Breathing Score Post 60 Minutes | Mentholated Paracetamol Hot Drink | 0.92 | 95% Confidence Interval 0.81 to 1.02 | Score on a scale | |
| Breathing Score Post 60 Minutes | Paracetamol Tablet | 0.34 | 95% Confidence Interval 0.23 to 0.44 | Score on a scale | |
| Cold Symptoms Score Post 15 Minutes | Mentholated Paracetamol Hot Drink | 0.64 | 95% Confidence Interval 0.52 to 0.75 | Score on a scale | |
| Cold Symptoms Score Post 15 Minutes | Paracetamol Tablet | 0.13 | 95% Confidence Interval 0.02 to 0.25 | Score on a scale | |
| Cold Symptoms Score Post 60 Minutes | Mentholated Paracetamol Hot Drink | 0.87 | 95% Confidence Interval 0.76 to 0.99 | Score on a scale | |
| Cold Symptoms Score Post 60 Minutes | Paracetamol Tablet | 0.35 | 95% Confidence Interval 0.24 to 0.46 | Score on a scale | |
| Soothing Attribute Scores | Mentholated Paracetamol Hot Drink | Average effect over first 15 minutes | 2.3 | Standard Deviation 0.80 | Score on a scale |
| Soothing Attribute Scores | Paracetamol Tablet | Average effect over first 15 minutes | 1.2 | Standard Deviation 0.88 | Score on a scale |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Mentholated Paracetamol Hot Drink | 100 | |
| Overall Study | STARTED | Paracetamol Tablet | 100 | |
| Overall Study | COMPLETED | Mentholated Paracetamol Hot Drink | 100 | |
| Overall Study | COMPLETED | Paracetamol Tablet | 100 | |
| Overall Study | NOT COMPLETED | Mentholated Paracetamol Hot Drink | 0 | |
| Overall Study | NOT COMPLETED | Paracetamol Tablet | 0 |
Source ClinicalTrials.gov
Adverse 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 | Mentholated Paracetamol Hot Drink | ||
| Total, all-cause mortality | Paracetamol Tablets | ||
| Total, other adverse events | Mentholated Paracetamol Hot Drink | 0 | 100 |
| Total, other adverse events | Paracetamol Tablets | 0 | 100 |
| Total, serious adverse events | Mentholated Paracetamol Hot Drink | 0 | 100 |
| Total, serious adverse events | Paracetamol Tablets | 0 | 100 |
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 |
|---|
| Mentholated Paracetamol Hot Drink vs Paracetamol Tablets: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
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/NCT01277081
GET https://conductscience.org/api/trials/v1/NCT01277081/registered