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The aim of this study is to subjectively assess symptoms in subjects suffering from the common cold following a single dose of paracetamol hot drink compared to paracetamol tablet
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paracetamol hot drink | Active Comparator | Hot drink containing paracetamol |
|
| Paracetamol tablets | Active Comparator | Paracetamol tablets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paracetamol hot drink | Drug | Hot drink containing paracetamol |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Breathing Scores Post 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. | Baseline to 15 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Breathing Score Post 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. |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Common Cold Centre | Cardiff | Wales | United Kingdom |
A total of 200 participants were screened and all were randomized into the study.
Participants were recruited at the clinical site.
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| ID | Title | Description |
|---|---|---|
| FG000 | Mentholated Paracetamol Hot Drink | Mentholated paracetamol hot drink prepared by dissolving 500 milligram (mg) of paracetamol in 200 milliliter (mL) of boiled mineral water was taken orally by participants within a time period of 15 minutes. |
| FG001 | Paracetamol Tablet | Paracetamol 500 mg tablet was taken orally with measured 200 mL of ambient mineral water. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Mentholated Paracetamol Hot Drink | Mentholated paracetamol hot drink prepared by dissolving 500 mg of paracetamol in 200 mL of boiled mineral water was taken orally by participants within a time period of 15 minutes. |
| BG001 | Paracetamol Tablet |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Breathing Scores Post 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. | Intent to Treat (ITT) Population: All randomized participants who had at least one post-baseline efficacy evaluation. | Posted | Mean | 95% Confidence Interval | Score on a Scale | Baseline to 15 minutes |
|
Adverse events were collected from the start of the treatment, and until 5 days following administration of the last dose of investigational product.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mentholated Paracetamol Hot Drink | Mentholated paracetamol hot drink prepared by dissolving 500 mg of paracetamol in 200 mL of boiled mineral water was taken orally by participants within a time period of 15 minutes. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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| ID | Term |
|---|---|
| D003139 | Common Cold |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Paracetamol tablets |
| Drug |
Paracetamol tablets |
|
| Baseline to 60 minutes |
| Cold Symptoms Score Post 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. | Baseline to 15 minutes |
| Cold Symptoms Score Post 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. | Baseline to 60 minutes |
| Soothing Attribute Scores | 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'. | Baseline to 15 and 60 minutes |
| Overall Cold Symptoms Score | 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'. | Baseline to 15 and 60 minutes |
Paracetamol 500 mg tablet was taken orally with measured 200 mL of ambient mineral water. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Mentholated paracetamol hot drink prepared by dissolving 500 mg of paracetamol in 200 mL of boiled mineral water was taken orally by participants within a time period of 15 minutes. |
| OG001 | Paracetamol Tablet | Paracetamol 500 mg tablet was taken orally with measured 200 mL of ambient mineral water. |
|
|
|
| Secondary | Breathing Score Post 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. | ITT population: All randomized participants who had at least one post-baseline efficacy evaluation. | Posted | Mean | 95% Confidence Interval | Score on a scale | Baseline to 60 minutes |
|
|
|
|
| Secondary | Cold Symptoms Score Post 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. | ITT Population: all randomized participants who had at least one post-baseline efficacy evaluation. | Posted | Mean | 95% Confidence Interval | Score on a scale | Baseline to 15 minutes |
|
|
|
|
| Secondary | Cold Symptoms Score Post 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. | ITT population: all randomized participants who had at least one post-baseline efficacy evaluation. | Posted | Mean | 95% Confidence Interval | Score on a scale | Baseline to 60 minutes |
|
|
|
|
| Secondary | Soothing Attribute Scores | 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'. | ITT population: all randomized participants who had at least one post-baseline efficacy evaluation. | Posted | Mean | Standard Deviation | Score on a scale | Baseline to 15 and 60 minutes |
|
|
|
| Secondary | Overall Cold Symptoms Score | 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'. | ITT population: all randomized participants who had at least one post-baseline efficacy evaluation. | Posted | Mean | Standard Error | Score on a scale | Baseline to 15 and 60 minutes |
|
|
|
| 0 |
| 100 |
| 0 |
| 100 |
| EG001 | Paracetamol Tablets | Paracetamol 500 mg tablet was taken orally with measured 200 mL of ambient mineral water. | 0 | 100 | 0 | 100 |
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D014777 |
| Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| Aniline Compounds |
| D000588 | Amines |