| Primary | Adjusted Mean Change From Baseline in Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) Total Score | The WURSS was an evaluative illness-specific quality of life instrument, designed to assess the negative impact of acute upper respiratory infection, presumed viral (the common cold). WURSS-21 was the short version of this validated survey. Participants rated their cold symptoms (10 questions) and Quality of Life (QoL) related 9 questions using WURSS-21. The responses were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptoms/Not at all and 7=Severe symptoms/Severely. Thus, the minimum and maximum possible total scores were 0 and 133 respectively, where higher total scores indicated more negative impact on symptoms and quality of life. Change from Baseline was calculated as each post-Baseline value minus Baseline value. EOT was defined as the day when the participant ceased study involvement because they no longer required relief from their cough/cold symptoms or the participant reached Day 7 (Or their last available questionnaire information). | The modified Intent-To-Treat (mITT) population included all participants who used study product at least once and had data from at least one post baseline QoL questionnaire to support at least one of the primary endpoint assessments. Only those participants with data available at the specified timepoint were analyzed. | Posted | | Least Squares Mean | 95% Confidence Interval | score on a scale | | Baseline and up to Day 7 or End of Treatment (EOT) | | | | ID | Title | Description |
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| OG000 | Robitussin Cough Syrup (Daytime) | Participants were instructed to take up to 20 ml of Robitussin Maximum Strength Cough and Chest Congestion DM syrup orally (not to exceed 6 doses in any 24-hour period) for up to 8 days or until resolution of symptoms, whichever occurred first. | | OG001 | Robitussin Cough Syrup (Daytime) + Robitussin Cough Syrup (Nighttime) | Participants were instructed to take up to 20 ml of Robitussin Maximum Strength Cough and Chest Congestion DM syrup and up to 20 ml of Robitussin Maximum Strength Nighttime Cough DM syrup orally (not to exceed 4 doses of daytime + 1 dose of nighttime or 3 doses of daytime + 2 doses of nighttime in any 24-hour period) for up to 8 days or until resolution of symptoms, whichever occurred first. |
| | | Title | Denominators | Categories |
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| Day 1 | - ParticipantsOG00099
- ParticipantsOG001101
| | Title | Measurements |
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| - OG000-9.56(-14.45 to -4.66)
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| Primary | Adjusted Mean Change From Baseline in WURSS-21 Total Symptom Domain Score | The WURSS was an evaluative illness specific quality of life instrument, designed to assess the negative impact of acute upper respiratory infection, presumed viral (the common cold). WURSS-21 was the short version of this validated survey. The symptom domain of WURSS-21 consisted of 10 questions. Participants rated their cold symptoms related questions and the responses were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptoms and 7=Severe. Thus, the minimum and maximum possible total score was 0 and 70 respectively, where higher scores indicated more negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value. | mITT population. Only those participants with data available at the specified timepoint were analyzed. EOT was defined as the day when the participant ceased study involvement because they no longer required relief from their cough/cold symptoms or the participant reached Day 7 (Or their last available questionnaire information). | Posted | | Least Squares Mean | 95% Confidence Interval | score on a scale | | Baseline and up to Day 7 or EOT | | | | ID | Title | Description |
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| OG000 | Robitussin Cough Syrup (Daytime) | Participants were instructed to take up to 20 ml of Robitussin Maximum Strength Cough and Chest Congestion DM syrup orally (not to exceed 6 doses in any 24-hour period) for up to 8 days or until resolution of symptoms, whichever occurred first. | | OG001 | Robitussin Cough Syrup (Daytime) + Robitussin Cough Syrup (Nighttime) |
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| Primary | Adjusted Mean Change From Baseline in WURSS-21 Total QoL Domain Score | The WURSS was an evaluative illness specific quality of life instrument, designed to assess the negative impact of acute upper respiratory infection, presumed viral (the common cold). WURSS-21 was the short version of this validated survey. The QoL domain of WURSS-21 consisted of 9 questions. Participants rated their QoL related questions and the responses were evaluated on a scale ranging from 0 to 7, where 0=Not at all and 7=Severely. Thus, the minimum and maximum possible total scores were 0 and 63 respectively, where higher scores indicated more negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value. | mITT population. Only those participants with data available at the specified timepoint were analyzed. EOT was defined as the day when the participant ceased study involvement because they no longer required relief from their cough/cold symptoms or the participant reached Day 7 (Or their last available questionnaire information). | Posted | | Least Squares Mean | 95% Confidence Interval | score on a scale | | Baseline and up to Day 7 or EOT | | | | ID | Title | Description |
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| OG000 | Robitussin Cough Syrup (Daytime) | Participants were instructed to take up to 20 ml of Robitussin Maximum Strength Cough and Chest Congestion DM syrup orally (not to exceed 6 doses in any 24-hour period) for up to 8 days or until resolution of symptoms, whichever occurred first. | | OG001 | Robitussin Cough Syrup (Daytime) + Robitussin Cough Syrup (Nighttime) |
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| Primary | Mean Change From Baseline in Each of the WURSS-21 Symptom Scores: Cough | The WURSS was an evaluative illness specific quality of life instrument, designed to assess the negative impact of acute upper respiratory infection, presumed viral (the common cold). WURSS-21 was the short version of this validated survey. The individual symptoms included runny nose, plugged nose, sneezing, sore throat, scratchy throat, cough, hoarseness, head congestion, chest congestion and feeling tired. Participants rated each of the 10 individual symptom domain questions and the responses were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severe. Thus, the minimum and maximum score for each symptom domain question was 0 and 7, where higher scores indicated more negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value. | mITT population. Only those participants with data available at the specified timepoint were analyzed. EOT was defined as the day when the participant ceased study involvement because they no longer required relief from their cough/cold symptoms or the participant reached Day 7 (Or their last available questionnaire information). | Posted | | Least Squares Mean | 95% Confidence Interval | score on a scale | | Baseline and up to Day 7 or EOT | | | | ID | Title | Description |
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| OG000 | Robitussin Cough Syrup (Daytime) | Participants were instructed to take up to 20 ml of Robitussin Maximum Strength Cough and Chest Congestion DM syrup orally (not to exceed 6 doses in any 24-hour period) for up to 8 days or until resolution of symptoms, whichever occurred first. |
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| Primary | Mean Change From Baseline in Each of the WURSS-21 Symptom Scores: Runny Nose | The WURSS was an evaluative illness specific quality of life instrument, designed to assess the negative impact of acute upper respiratory infection, presumed viral (the common cold). WURSS-21 was the short version of this validated survey. The individual symptoms included runny nose, plugged nose, sneezing, sore throat, scratchy throat, cough, hoarseness, head congestion, chest congestion and feeling tired. Participants rated each of the 10 individual symptom domain questions and the responses were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severe. Thus, the minimum and maximum score for each symptom domain question was 0 and 7, where higher scores indicated more negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value. | mITT population. Only those participants with data available at the specified timepoint were analyzed. EOT was defined as the day when the participant ceased study involvement because they no longer required relief from their cough/cold symptoms or the participant reached Day 7 (Or their last available questionnaire information). | Posted | | Mean | Standard Deviation | score on a scale | | Baseline and up to Day 7 or EOT | | | | ID | Title | Description |
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| OG000 | Robitussin Cough Syrup (Daytime) | Participants were instructed to take up to 20 ml of Robitussin Maximum Strength Cough and Chest Congestion DM syrup orally (not to exceed 6 doses in any 24-hour period) for up to 8 days or until resolution of symptoms, whichever occurred first. | |
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| Primary | Mean Change From Baseline in Each of the WURSS-21 Symptom Scores: Plugged Nose | The WURSS was an evaluative illness specific quality of life instrument, designed to assess the negative impact of acute upper respiratory infection, presumed viral (the common cold). WURSS-21 was the short version of this validated survey. The individual symptoms included runny nose, plugged nose, sneezing, sore throat, scratchy throat, cough, hoarseness, head congestion, chest congestion and feeling tired. Participants rated each of the 10 individual symptom domain questions and the responses were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severe. Thus, the minimum and maximum score for each symptom domain question was 0 and 7, where higher scores indicated more negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value. | mITT population. Only those participants with data available at the specified timepoint were analyzed. EOT was defined as the day when the participant ceased study involvement because they no longer required relief from their cough/cold symptoms or the participant reached Day 7 (Or their last available questionnaire information). | Posted | | Mean | Standard Deviation | score on a scale | | Baseline and up to Day 7 or EOT | | | | ID | Title | Description |
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| OG000 | Robitussin Cough Syrup (Daytime) | Participants were instructed to take up to 20 ml of Robitussin Maximum Strength Cough and Chest Congestion DM syrup orally (not to exceed 6 doses in any 24-hour period) for up to 8 days or until resolution of symptoms, whichever occurred first. | |
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| Primary | Mean Change From Baseline in Each of the WURSS-21 Symptom Scores: Sneezing | The WURSS was an evaluative illness specific quality of life instrument, designed to assess the negative impact of acute upper respiratory infection, presumed viral (the common cold). WURSS-21 was the short version of this validated survey. The individual symptoms included runny nose, plugged nose, sneezing, sore throat, scratchy throat, cough, hoarseness, head congestion, chest congestion and feeling tired. Participants rated each of the 10 individual symptom domain questions and the responses were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severe. Thus, the minimum and maximum score for each symptom domain question was 0 and 7, where higher scores indicated more negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value. | mITT population. Only those participants with data available at the specified timepoint were analyzed. EOT was defined as the day when the participant ceased study involvement because they no longer required relief from their cough/cold symptoms or the participant reached Day 7 (Or their last available questionnaire information). | Posted | | Mean | Standard Deviation | score on a scale | | Baseline and up to Day 7 or EOT | | | | ID | Title | Description |
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| OG000 | Robitussin Cough Syrup (Daytime) | Participants were instructed to take up to 20 ml of Robitussin Maximum Strength Cough and Chest Congestion DM syrup orally (not to exceed 6 doses in any 24-hour period) for up to 8 days or until resolution of symptoms, whichever occurred first. | |
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| Primary | Mean Change From Baseline in Each of the WURSS-21 Symptom Scores: Sore Throat | The WURSS was an evaluative illness specific quality of life instrument, designed to assess the negative impact of acute upper respiratory infection, presumed viral (the common cold). WURSS-21 was the short version of this validated survey. The individual symptoms included runny nose, plugged nose, sneezing, sore throat, scratchy throat, cough, hoarseness, head congestion, chest congestion and feeling tired. Participants rated each of the 10 individual symptom domain questions and the responses were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severe. Thus, the minimum and maximum score for each symptom domain question was 0 and 7, where higher scores indicated more negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value. | mITT population. Only those participants with data available at the specified timepoint were analyzed. EOT was defined as the day when the participant ceased study involvement because they no longer required relief from their cough/cold symptoms or the participant reached Day 7 (Or their last available questionnaire information). | Posted | | Mean | Standard Deviation | score on a scale | | Baseline and up to Day 7 or EOT | | | | ID | Title | Description |
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| OG000 | Robitussin Cough Syrup (Daytime) | Participants were instructed to take up to 20 ml of Robitussin Maximum Strength Cough and Chest Congestion DM syrup orally (not to exceed 6 doses in any 24-hour period) for up to 8 days or until resolution of symptoms, whichever occurred first. | |
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| Primary | Mean Change From Baseline in Each of the WURSS-21 Symptom Scores: Scratchy Throat | The WURSS was an evaluative illness specific quality of life instrument, designed to assess the negative impact of acute upper respiratory infection, presumed viral (the common cold). WURSS-21 was the short version of this validated survey. The individual symptoms included runny nose, plugged nose, sneezing, sore throat, scratchy throat, cough, hoarseness, head congestion, chest congestion and feeling tired. Participants rated each of the 10 individual symptom domain questions and the responses were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severe. Thus, the minimum and maximum score for each symptom domain question was 0 and 7, where higher scores indicated more negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value. | mITT population. Only those participants with data available at the specified timepoint were analyzed. EOT was defined as the day when the participant ceased study involvement because they no longer required relief from their cough/cold symptoms or the participant reached Day 7 (Or their last available questionnaire information). | Posted | | Mean | Standard Deviation | score on a scale | | Baseline and up to Day 7 or EOT | | | | ID | Title | Description |
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| OG000 | Robitussin Cough Syrup (Daytime) | Participants were instructed to take up to 20 ml of Robitussin Maximum Strength Cough and Chest Congestion DM syrup orally (not to exceed 6 doses in any 24-hour period) for up to 8 days or until resolution of symptoms, whichever occurred first. |
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| Primary | Mean Change From Baseline in Each of the WURSS-21 Symptom Scores: Hoarseness | The WURSS was an evaluative illness specific quality of life instrument, designed to assess the negative impact of acute upper respiratory infection, presumed viral (the common cold). WURSS-21 was the short version of this validated survey. The individual symptoms include runny nose, plugged nose, sneezing, sore throat, scratchy throat, cough, hoarseness, head congestion, chest congestion and feeling tired. Participants rated each of the 10 individual symptom domain questions and the responses were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severe. Thus, the minimum and maximum score for each symptom domain question was 0 and 7, where higher scores indicated more negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value. | mITT population. Only those participants with data available at the specified timepoint were analyzed. EOT was defined as the day when the participant ceased study involvement because they no longer required relief from their cough/cold symptoms or the participant reached Day 7 (Or their last available questionnaire information). | Posted | | Mean | Standard Deviation | score on a scale | | Baseline and up to Day 7 or EOT | | | | ID | Title | Description |
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| OG000 | Robitussin Cough Syrup (Daytime) | Participants were instructed to take up to 20 ml of Robitussin Maximum Strength Cough and Chest Congestion DM syrup orally (not to exceed 6 doses in any 24-hour period) for up to 8 days or until resolution of symptoms, whichever occurred first. | |
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| Primary | Mean Change From Baseline in Each of the WURSS-21 Symptom Scores: Head Congestion | The WURSS was an evaluative illness specific quality of life instrument, designed to assess the negative impact of acute upper respiratory infection, presumed viral (the common cold). WURSS-21 was the short version of this validated survey. The individual symptoms included runny nose, plugged nose, sneezing, sore throat, scratchy throat, cough, hoarseness, head congestion, chest congestion and feeling tired. Participants rated each of the 10 individual symptom domain questions and the responses were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severe. Thus, the minimum and maximum score for each symptom domain question was 0 and 7, where higher scores indicated more negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value. | mITT population. Only those participants with data available at the specified timepoint were analyzed. EOT was defined as the day when the participant ceased study involvement because they no longer required relief from their cough/cold symptoms or the participant reached Day 7 (Or their last available questionnaire information). | Posted | | Mean | Standard Deviation | score on a scale | | Baseline and up to Day 7 or EOT | | | | ID | Title | Description |
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| OG000 | Robitussin Cough Syrup (Daytime) | Participants were instructed to take up to 20 ml of Robitussin Maximum Strength Cough and Chest Congestion DM syrup orally (not to exceed 6 doses in any 24-hour period) for up to 8 days or until resolution of symptoms, whichever occurred first. |
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| Primary | Mean Change From Baseline in Each of the WURSS-21 Symptom Scores: Chest Congestion | The WURSS was an evaluative illness specific quality of life instrument, designed to assess the negative impact of acute upper respiratory infection, presumed viral (the common cold). WURSS-21 was the short version of this validated survey. The individual symptoms included runny nose, plugged nose, sneezing, sore throat, scratchy throat, cough, hoarseness, head congestion, chest congestion and feeling tired. Participants rated each of the 10 individual symptom domain questions and the responses were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severe. Thus, the minimum and maximum score for each symptom domain question was 0 and 7, where higher scores indicated more negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value. | mITT population. Only those participants with data available at the specified timepoint were analyzed. EOT was defined as the day when the participant ceased study involvement because they no longer required relief from their cough/cold symptoms or the participant reached Day 7 (Or their last available questionnaire information). | Posted | | Mean | Standard Deviation | score on a scale | | Baseline and up to Day 7 or EOT | | | | ID | Title | Description |
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| OG000 | Robitussin Cough Syrup (Daytime) | Participants were instructed to take up to 20 ml of Robitussin Maximum Strength Cough and Chest Congestion DM syrup orally (not to exceed 6 doses in any 24-hour period) for up to 8 days or until resolution of symptoms, whichever occurred first. |
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| Primary | Mean Change From Baseline in Each of the WURSS-21 Symptom Scores: Feeling Tired | The WURSS was an evaluative illness specific quality of life instrument, designed to assess the negative impact of acute upper respiratory infection, presumed viral (the common cold). WURSS-21 was the short version of this validated survey. The individual symptoms included runny nose, plugged nose, sneezing, sore throat, scratchy throat, cough, hoarseness, head congestion, chest congestion and feeling tired. Participants rated each of the 10 individual symptom domain questions and the responses were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severe. Thus, the minimum and maximum score for each symptom domain question was 0 and 7, where higher scores indicated more negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value. | mITT population. Only those participants with data available at the specified timepoint were analyzed. EOT was defined as the day when the participant ceased study involvement because they no longer required relief from their cough/cold symptoms or the participant reached Day 7 (Or their last available questionnaire information). | Posted | | Mean | Standard Deviation | score on a scale | | Baseline and up to Day 7 or EOT | | | | ID | Title | Description |
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| OG000 | Robitussin Cough Syrup (Daytime) | Participants were instructed to take up to 20 ml of Robitussin Maximum Strength Cough and Chest Congestion DM syrup orally (not to exceed 6 doses in any 24-hour period) for up to 8 days or until resolution of symptoms, whichever occurred first. |
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| Primary | Mean Change From Baseline in Each of the WURSS-21 QoL Questions Scores: Think Clearly | The WURSS was an evaluative illness specific quality of life instrument, designed to assess the negative impact of acute upper respiratory infection, presumed viral (the common cold). WURSS-21 was the short version of this validated survey. The QoL domain of WURSS-21 consisted of 9 questions. Participants rated each QoL questions indicating how cold interfered with their ability to perform daily activities, and the responses were evaluated on a scale ranging from 0 to 7, where 0=Not at all and 7=Severely. Thus, the minimum and maximum possible total scores were 0 and 7 respectively, where higher scores indicated more negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value. | mITT population. Only those participants with data available at the specified timepoint were analyzed. EOT was defined as the day when the participant ceased study involvement because they no longer required relief from their cough/cold symptoms or the participant reached Day 7 (Or their last available questionnaire information). | Posted | | Mean | Standard Deviation | score on a scale | | Baseline and up to Day 7 or EOT | | | | ID | Title | Description |
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| OG000 | Robitussin Cough Syrup (Daytime) | Participants were instructed to take up to 20 ml of Robitussin Maximum Strength Cough and Chest Congestion DM syrup orally (not to exceed 6 doses in any 24-hour period) for up to 8 days or until resolution of symptoms, whichever occurred first. | | OG001 |
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| Primary | Mean Change From Baseline in Each of the WURSS-21 QoL Questions Scores: Sleep Well | The WURSS was an evaluative illness specific quality of life instrument, designed to assess the negative impact of acute upper respiratory infection, presumed viral (the common cold). WURSS-21 was the short version of this validated survey. The QoL domain of WURSS-21 consisted of 9 questions. Participants rated each QoL questions indicating how cold interfered with their ability to perform daily activities, and the responses were evaluated on a scale ranging from 0 to 7, where 0=Not at all and 7=Severely. Thus, the minimum and maximum possible total scores were 0 and 7 respectively, where higher scores indicate more negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value. | mITT population. Only those participants with data available at the specified timepoint were analyzed. EOT was defined as the day when the participant ceased study involvement because they no longer required relief from their cough/cold symptoms or the participant reached Day 7 (Or their last available questionnaire information). | Posted | | Mean | Standard Deviation | score on a scale | | Baseline and up to Day 7 or EOT | | | | ID | Title | Description |
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| OG000 | Robitussin Cough Syrup (Daytime) | Participants were instructed to take up to 20 ml of Robitussin Maximum Strength Cough and Chest Congestion DM syrup orally (not to exceed 6 doses in any 24-hour period) for up to 8 days or until resolution of symptoms, whichever occurred first. | | OG001 |
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| Primary | Mean Change From Baseline in Each of the WURSS-21 QoL Questions Scores: Breathe Easily | The WURSS was an evaluative illness specific quality of life instrument, designed to assess the negative impact of acute upper respiratory infection, presumed viral (the common cold). WURSS-21 was the short version of this validated survey. The QoL domain of WURSS-21 consisted of 9 questions. Participants rated each QoL questions indicating how cold interfered with their ability to perform daily activities, and the responses were evaluated on a scale ranging from 0 to 7, where 0=Not at all and 7=Severely. Thus, the minimum and maximum possible total scores were 0 and 7 respectively, where higher scores indicated more negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value. | mITT population. Only those participants with data available at the specified timepoint were analyzed. EOT was defined as the day when the participant ceased study involvement because they no longer required relief from their cough/cold symptoms or the participant reached Day 7 (Or their last available questionnaire information). | Posted | | Mean | Standard Deviation | score on a scale | | Baseline and up to Day 7 or EOT | | | | ID | Title | Description |
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| OG000 | Robitussin Cough Syrup (Daytime) | Participants were instructed to take up to 20 ml of Robitussin Maximum Strength Cough and Chest Congestion DM syrup orally (not to exceed 6 doses in any 24-hour period) for up to 8 days or until resolution of symptoms, whichever occurred first. | | OG001 |
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| Primary | Mean Change From Baseline in Each of the WURSS-21 QoL Questions Scores: Walk, Climb Stairs, Exercise | The WURSS was an evaluative illness specific quality of life instrument, designed to assess the negative impact of acute upper respiratory infection, presumed viral (the common cold). WURSS-21 was the short version of this validated survey. The QoL domain of WURSS-21 consisted of 9 questions. Participants rated each QoL questions indicating how cold interfered with their ability to perform daily activities, and the responses were evaluated on a scale ranging from 0 to 7, where 0=Not at all and 7=Severely. Thus, the minimum and maximum possible total scores were 0 and 7 respectively, where higher scores indicated more negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value. | mITT population. Only those participants with data available at the specified timepoint were analyzed. EOT was defined as the day when the participant ceased study involvement because they no longer required relief from their cough/cold symptoms or the participant reached Day 7 (Or their last available questionnaire information). | Posted | | Mean | Standard Deviation | score on a scale | | Baseline and up to Day 7 or EOT | | | | ID | Title | Description |
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| OG000 | Robitussin Cough Syrup (Daytime) | Participants were instructed to take up to 20 ml of Robitussin Maximum Strength Cough and Chest Congestion DM syrup orally (not to exceed 6 doses in any 24-hour period) for up to 8 days or until resolution of symptoms, whichever occurred first. | | OG001 |
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| Primary | Mean Change From Baseline in Each of the WURSS-21 QoL Questions Scores: Accomplish Daily Activities | The WURSS was an evaluative illness specific quality of life instrument, designed to assess the negative impact of acute upper respiratory infection, presumed viral (the common cold). WURSS-21 was the short version of this validated survey. The QoL domain of WURSS-21 consisted of 9 questions. Participants rated each QoL questions indicating how cold interfered with their ability to perform daily activities, and the responses were evaluated on a scale ranging from 0 to 7, where 0=Not at all and 7=Severely. Thus, the minimum and maximum possible total scores were 0 and 7 respectively, where higher scores indicated more negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value. | mITT population. Only those participants with data available at the specified timepoint were analyzed. EOT was defined as the day when the participant ceased study involvement because they no longer required relief from their cough/cold symptoms or the participant reached Day 7 (Or their last available questionnaire information). | Posted | | Mean | Standard Deviation | score on a scale | | Baseline and up to Day 7 or EOT | | | | ID | Title | Description |
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| OG000 | Robitussin Cough Syrup (Daytime) | Participants were instructed to take up to 20 ml of Robitussin Maximum Strength Cough and Chest Congestion DM syrup orally (not to exceed 6 doses in any 24-hour period) for up to 8 days or until resolution of symptoms, whichever occurred first. | | OG001 |
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| Primary | Mean Change From Baseline in Each of the WURSS-21 QoL Questions Scores: Work Outside the Home | The WURSS was an evaluative illness specific quality of life instrument, designed to assess the negative impact of acute upper respiratory infection, presumed viral (the common cold). WURSS-21 was the short version of this validated survey. The QoL domain of WURSS-21 consisted of 9 questions. Participants rated each QoL questions indicating how cold interfered with their ability to perform daily activities, and the responses were evaluated on a scale ranging from 0 to 7, where 0=Not at all and 7=Severely. Thus, the minimum and maximum possible total scores were 0 and 7 respectively, where higher scores indicated more negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value. | mITT population. Only those participants with data available at the specified timepoint were analyzed. EOT was defined as the day when the participant ceased study involvement because they no longer required relief from their cough/cold symptoms or the participant reached Day 7 (Or their last available questionnaire information). | Posted | | Mean | Standard Deviation | score on a scale | | Baseline and up to Day 7 or EOT | | | | ID | Title | Description |
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| OG000 | Robitussin Cough Syrup (Daytime) | Participants were instructed to take up to 20 ml of Robitussin Maximum Strength Cough and Chest Congestion DM syrup orally (not to exceed 6 doses in any 24-hour period) for up to 8 days or until resolution of symptoms, whichever occurred first. | | OG001 |
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| Primary | Mean Change From Baseline in Each of the WURSS-21 QoL Questions Scores: Work Inside the Home | The WURSS was an evaluative illness specific quality of life instrument, designed to assess the negative impact of acute upper respiratory infection, presumed viral (the common cold). WURSS-21 was the short version of this validated survey. The QoL domain of WURSS-21 consisted of 9 questions. Participants rated each QoL questions indicating how cold interfered with their ability to perform daily activities, and the responses were evaluated on a scale ranging from 0 to 7, where 0=Not at all and 7=Severely. Thus, the minimum and maximum possible total scores were 0 and 7 respectively, where higher scores indicated more negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value. | mITT population. Only those participants with data available at the specified timepoint were analyzed. EOT was defined as the day when the participant ceased study involvement because they no longer required relief from their cough/cold symptoms or the participant reached Day 7 (Or their last available questionnaire information). | Posted | | Mean | Standard Deviation | score on a scale | | Baseline and up to Day 7 or EOT | | | | ID | Title | Description |
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| OG000 | Robitussin Cough Syrup (Daytime) | Participants were instructed to take up to 20 ml of Robitussin Maximum Strength Cough and Chest Congestion DM syrup orally (not to exceed 6 doses in any 24-hour period) for up to 8 days or until resolution of symptoms, whichever occurred first. | | OG001 |
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| Primary | Mean Change From Baseline in Each of the WURSS-21 QoL Questions Scores: Interact With Others | The WURSS was an evaluative illness specific quality of life instrument, designed to assess the negative impact of acute upper respiratory infection, presumed viral (the common cold). WURSS-21 was the short version of this validated survey. The QoL domain of WURSS-21 consisted of 9 questions. Participants rated each QoL questions indicating how cold interfered with their ability to perform daily activities, and the responses were evaluated on a scale ranging from 0 to 7, where 0=Not at all and 7=Severely. Thus, the minimum and maximum possible total scores were 0 and 7 respectively, where higher scores indicated more negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value. | mITT population. Only those participants with data available at the specified timepoint were analyzed. EOT was defined as the day when the participant ceased study involvement because they no longer required relief from their cough/cold symptoms or the participant reached Day 7 (Or their last available questionnaire information). | Posted | | Mean | Standard Deviation | score on a scale | | Baseline and up to Day 7 or EOT | | | | ID | Title | Description |
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| OG000 | Robitussin Cough Syrup (Daytime) | Participants were instructed to take up to 20 ml of Robitussin Maximum Strength Cough and Chest Congestion DM syrup orally (not to exceed 6 doses in any 24-hour period) for up to 8 days or until resolution of symptoms, whichever occurred first. | | OG001 |
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| Primary | Mean Change From Baseline in Each of the WURSS-21 QoL Questions Scores: Live Your Personal Life | The WURSS was an evaluative illness specific quality of life instrument, designed to assess the negative impact of acute upper respiratory infection, presumed viral (the common cold). WURSS-21 was the short version of this validated survey. The QoL domain of WURSS-21 consisted of 9 questions. Participants rated each QoL questions indicating how cold interfered with their ability to perform daily activities, and the responses were evaluated on a scale ranging from 0 to 7, where 0=Not at all and 7=Severely. Thus, the minimum and maximum possible total scores were 0 and 7 respectively, where higher scores indicated more negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value. | mITT population. Only those participants with data available at the specified timepoint were analyzed. EOT was defined as the day when the participant ceased study involvement because they no longer required relief from their cough/cold symptoms or the participant reached Day 7 (Or their last available questionnaire information). | Posted | | Mean | Standard Deviation | score on a scale | | Baseline and up to Day 7 or EOT | | | | ID | Title | Description |
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| OG000 | Robitussin Cough Syrup (Daytime) | Participants were instructed to take up to 20 ml of Robitussin Maximum Strength Cough and Chest Congestion DM syrup orally (not to exceed 6 doses in any 24-hour period) for up to 8 days or until resolution of symptoms, whichever occurred first. | | OG001 |
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| Secondary | Mean Change From Baseline in QoL Factors Score Assessed Using Specific QoL Questions: Social Activities | QoL factors were assessed using specific questions related to social activities, feeling self-conscious around people, coughing in public, falling asleep, sleeping through the night, energy, and motivation. Participants rated their response to questions on a scale ranging from 0 to 7, where 0= Not at all and 7= Severely. Thus, the minimum and maximum score for each question was 0 and 7 respectively, where higher scores indicated more negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value. | mITT population. Only those participants with data available at the specified timepoint were analyzed. EOT was defined as the day when the participant ceased study involvement because they no longer required relief from their cough/cold symptoms or the participant reached Day 7 (Or their last available questionnaire information). | Posted | | Mean | Standard Deviation | score on a scale | | Baseline and up to Day 7 or EOT | | | | ID | Title | Description |
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| OG000 | Robitussin Cough Syrup (Daytime) | Participants were instructed to take up to 20 ml of Robitussin Maximum Strength Cough and Chest Congestion DM syrup orally (not to exceed 6 doses in any 24-hour period) for up to 8 days or until resolution of symptoms, whichever occurred first. | | OG001 | Robitussin Cough Syrup (Daytime) + Robitussin Cough Syrup (Nighttime) | |
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| Secondary | Mean Change From Baseline in QoL Factors Score Assessed Using Specific QoL Questions: Self-conscious Around People | QoL factors were assessed using specific questions related to social activities, feeling self-conscious around people, coughing in public, falling asleep, sleeping through the night, energy, and motivation. Participants rated their response to questions on a scale ranging from 0 to 7, where 0= Not at all and 7= Severely. Thus, the minimum and maximum score for each question was 0 and 7 respectively, where higher scores indicated more negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value. | mITT population. Only those participants with data available at the specified timepoint were analyzed. EOT was defined as the day when the participant ceased study involvement because they no longer required relief from their cough/cold symptoms or the participant reached Day 7 (Or their last available questionnaire information). | Posted | | Mean | Standard Deviation | score on a scale | | Baseline and up to Day 7 or EOT | | | | ID | Title | Description |
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| OG000 | Robitussin Cough Syrup (Daytime) | Participants were instructed to take up to 20 ml of Robitussin Maximum Strength Cough and Chest Congestion DM syrup orally (not to exceed 6 doses in any 24-hour period) for up to 8 days or until resolution of symptoms, whichever occurred first. | | OG001 | Robitussin Cough Syrup (Daytime) + Robitussin Cough Syrup (Nighttime) | |
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| Secondary | Mean Change From Baseline in QoL Factors Score Assessed Using Specific QoL Questions: Coughing in Public | QoL factors were assessed using specific questions related to social activities, feeling self-conscious around people, coughing in public, falling asleep, sleeping through the night, energy, and motivation. Participants rated their response to questions on a scale ranging from 0 to 7, where 0= Not at all and 7= Severely. Thus, the minimum and maximum score for each question was 0 and 7 respectively, where higher scores indicated more negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value. | mITT population. Only those participants with data available at the specified timepoint were analyzed. EOT was defined as the day when the participant ceased study involvement because they no longer required relief from their cough/cold symptoms or the participant reached Day 7 (Or their last available questionnaire information). | Posted | | Mean | Standard Deviation | score on a scale | | Baseline and up to Day 7 or EOT | | | | ID | Title | Description |
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| OG000 | Robitussin Cough Syrup (Daytime) | Participants were instructed to take up to 20 ml of Robitussin Maximum Strength Cough and Chest Congestion DM syrup orally (not to exceed 6 doses in any 24-hour period) for up to 8 days or until resolution of symptoms, whichever occurred first. | | OG001 | Robitussin Cough Syrup (Daytime) + Robitussin Cough Syrup (Nighttime) | |
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| Secondary | Mean Change From Baseline in QoL Factors Score Assessed Using Specific QoL Questions: Falling Asleep | QoL factors were assessed using specific questions related to social activities, feeling self-conscious around people, coughing in public, falling asleep, sleeping through the night, energy, and motivation. Participants rated their response to questions on a scale ranging from 0 to 7, where 0= Not at all and 7= Severely. Thus, the minimum and maximum score for each question was 0 and 7 respectively, where higher scores indicated more negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value. | mITT population. Only those participants with data available at the specified timepoint were analyzed. EOT was defined as the day when the participant ceased study involvement because they no longer required relief from their cough/cold symptoms or the participant reached Day 7 (Or their last available questionnaire information). | Posted | | Mean | Standard Deviation | score on a scale | | Baseline and up to Day 7 or EOT | | | | ID | Title | Description |
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| OG000 | Robitussin Cough Syrup (Daytime) | Participants were instructed to take up to 20 ml of Robitussin Maximum Strength Cough and Chest Congestion DM syrup orally (not to exceed 6 doses in any 24-hour period) for up to 8 days or until resolution of symptoms, whichever occurred first. | | OG001 | Robitussin Cough Syrup (Daytime) + Robitussin Cough Syrup (Nighttime) | |
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| Secondary | Mean Change From Baseline in QoL Factors Score Assessed Using Specific QoL Questions: Sleeping Through the Night | QoL factors were assessed using specific questions related to social activities, feeling self-conscious around people, coughing in public, falling asleep, sleeping through the night, energy, and motivation. Participants rated their response to questions on a scale ranging from 0 to 7, where 0= Not at all and 7= Severely. Thus, the minimum and maximum score for each question was 0 and 7 respectively, where higher scores indicated more negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value. | mITT population. Only those participants with data available at the specified timepoint were analyzed. EOT was defined as the day when the participant ceased study involvement because they no longer required relief from their cough/cold symptoms or the participant reached Day 7 (Or their last available questionnaire information). | Posted | | Mean | Standard Deviation | score on a scale | | Baseline and up to Day 7 or EOT | | | | ID | Title | Description |
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| OG000 | Robitussin Cough Syrup (Daytime) | Participants were instructed to take up to 20 ml of Robitussin Maximum Strength Cough and Chest Congestion DM syrup orally (not to exceed 6 doses in any 24-hour period) for up to 8 days or until resolution of symptoms, whichever occurred first. | | OG001 | Robitussin Cough Syrup (Daytime) + Robitussin Cough Syrup (Nighttime) | |
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| Secondary | Mean Change From Baseline in QoL Factors Score Assessed Using Specific QoL Questions: Energy | QoL factors were assessed using specific questions related to social activities, feeling self-conscious around people, coughing in public, falling asleep, sleeping through the night, energy, and motivation. Participants rated their response to questions on a scale ranging from 0 to 7, where 0= Not at all and 7= Severely. Thus, the minimum and maximum score for each question was 0 and 7 respectively, where higher scores indicated more negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value. | mITT population. Only those participants with data available at the specified timepoint were analyzed. EOT was defined as the day when the participant ceased study involvement because they no longer required relief from their cough/cold symptoms or the participant reached Day 7 (Or their last available questionnaire information). | Posted | | Mean | Standard Deviation | score on a scale | | Baseline and up to Day 7 or EOT | | | | ID | Title | Description |
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| OG000 | Robitussin Cough Syrup (Daytime) | Participants were instructed to take up to 20 ml of Robitussin Maximum Strength Cough and Chest Congestion DM syrup orally (not to exceed 6 doses in any 24-hour period) for up to 8 days or until resolution of symptoms, whichever occurred first. | | OG001 | Robitussin Cough Syrup (Daytime) + Robitussin Cough Syrup (Nighttime) | |
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| Secondary | Mean Change From Baseline in QoL Factors Score Assessed Using Specific QoL Questions: Motivation | QoL factors were assessed using specific questions related to social activities, feeling self-conscious around people, coughing in public, falling asleep, sleeping through the night, energy, and motivation. Participants rated their response to questions on a scale ranging from 0 to 7, where 0= Not at all and 7= Severely. Thus, the minimum and maximum score for each question was 0 and 7 respectively, where higher scores indicated more negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value. | mITT population. Only those participants with data available at the specified timepoint were analyzed. EOT was defined as the day when the participant ceased study involvement because they no longer required relief from their cough/cold symptoms or the participant reached Day 7 (Or their last available questionnaire information). | Posted | | Mean | Standard Deviation | score on a scale | | Baseline and up to Day 7 or EOT | | | | ID | Title | Description |
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| OG000 | Robitussin Cough Syrup (Daytime) | Participants were instructed to take up to 20 ml of Robitussin Maximum Strength Cough and Chest Congestion DM syrup orally (not to exceed 6 doses in any 24-hour period) for up to 8 days or until resolution of symptoms, whichever occurred first. | | OG001 | Robitussin Cough Syrup (Daytime) + Robitussin Cough Syrup (Nighttime) | |
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| Secondary | Mean Change From Baseline in Categorized QoL Questions Score: Sleep Quality | The QoL factors were categorized into 4 categories - Sleep quality, Vitality, Physical activity and Social activity. Sleep quality category included 3 individual questions - Sleep well (WURSS-21: Question 13), Falling asleep (QoL: Question 4) and Sleep through the night (QoL: Question 5). Participants rated each question, and the responses were evaluated on a scale ranging from 0 to 7, where 0=Not at all and 7=Severely. The individual question score was added to derive categorized QoL score. Thus, the minimum and maximum possible total scores was 0 and 21 respectively, where higher scores indicated more negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value. | mITT population. Only those participants with data available at the specified timepoint were analyzed. EOT was defined as the day when the participant ceased study involvement because they no longer required relief from their cough/cold symptoms or the participant reached Day 7 (Or their last available questionnaire information). | Posted | | Mean | Standard Deviation | score on a scale | | Baseline and up to Day 7 or EOT | | | | ID | Title | Description |
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| OG000 | Robitussin Cough Syrup (Daytime) | Participants were instructed to take up to 20 ml of Robitussin Maximum Strength Cough and Chest Congestion DM syrup orally (not to exceed 6 doses in any 24-hour period) for up to 8 days or until resolution of symptoms, whichever occurred first. | | OG001 | Robitussin Cough Syrup (Daytime) + Robitussin Cough Syrup (Nighttime) |
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| Secondary | Mean Change From Baseline in Categorized QoL Questions Score: Vitality | The QoL factors were categorized into 4 categories - Sleep quality, Vitality, Physical activity and Social activity. Vitality category was assessed using 3 individual questions - Energy (QoL: Question 6), Motivation (QoL: Question 7), and Feel tired (WURSS-21: Question 11). Participants rated each question, and the responses were evaluated on a scale ranging from 0 to 7, where 0=Not at all and 7=Severely. The individual question score was added to derive categorized QoL score. Thus, the minimum and maximum possible total score was 0 and 21 respectively, where higher scores indicated more negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value. | mITT population. Only those participants with data available at the specified timepoint were analyzed. EOT was defined as the day when the participant ceased study involvement because they no longer required relief from their cough/cold symptoms or the participant reached Day 7 (Or their last available questionnaire information). | Posted | | Mean | Standard Deviation | score on a scale | | Baseline and up to Day 7 or EOT | | | | ID | Title | Description |
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| OG000 | Robitussin Cough Syrup (Daytime) | Participants were instructed to take up to 20 ml of Robitussin Maximum Strength Cough and Chest Congestion DM syrup orally (not to exceed 6 doses in any 24-hour period) for up to 8 days or until resolution of symptoms, whichever occurred first. | | OG001 | Robitussin Cough Syrup (Daytime) + Robitussin Cough Syrup (Nighttime) |
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| Secondary | Mean Change From Baseline in Categorized QoL Questions Score: Physical Activities | The QoL factors were categorized into 4 categories - Sleep quality, Vitality, Physical activity and Social activity. Physical Activities were assessed using 3 individual questions - Breathe easily (WURSS-21: Question 14), Walk, climb stairs, exercise (WURSS-21: Question 15) and Accomplish daily activities (WURSS-21: Question 16). Participants rated each question, and the responses were evaluated on a scale ranging from 0 to 7, where 0=Not at all and 7=Severely. The individual question score was added to derive categorized QoL score. Thus, the minimum and maximum possible total score was 0 and 21 respectively, where higher scores indicated more negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value. | mITT population. Only those participants with data available at the specified timepoint were analyzed. EOT was defined as the day when the participant ceased study involvement because they no longer required relief from their cough/cold symptoms or the participant reached Day 7 (Or their last available questionnaire information). | Posted | | Mean | Standard Deviation | score on a scale | | Baseline and up to Day 7 or EOT | | | | ID | Title | Description |
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| OG000 | Robitussin Cough Syrup (Daytime) | Participants were instructed to take up to 20 ml of Robitussin Maximum Strength Cough and Chest Congestion DM syrup orally (not to exceed 6 doses in any 24-hour period) for up to 8 days or until resolution of symptoms, whichever occurred first. | | OG001 |
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| Secondary | Mean Change From Baseline in Categorized QoL Questions Score: Social Activities | The QoL factors were categorized into 4 categories - Sleep quality, Vitality, Physical activity and Social activity. Social Activities were assessed using 4 individual questions - Interact with others (WURSS-21: Question 19), Less comfortable in social activities (QoL: Question 1), Self-conscious around others (QoL: Question 2) and Coughing in public (QoL: Question 3). Participants rated each question and the responses were evaluated on a scale ranging from 0 to 7, where 0=Not at all and 7=Severely. The individual question score was added to derive categorized QoL score. Thus, the minimum and maximum possible total score was 0 and 28 respectively, where higher scores indicated more negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value. | mITT population. Only those participants with data available at the specified timepoint were analyzed. EOT was defined as the day when the participant ceased study involvement because they no longer required relief from their cough/cold symptoms or the participant reached Day 7 (Or their last available questionnaire information). | Posted | | Mean | Standard Deviation | score on a scale | | Baseline and up to Day 7 or EOT | | | | ID | Title | Description |
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| OG000 | Robitussin Cough Syrup (Daytime) | Participants were instructed to take up to 20 ml of Robitussin Maximum Strength Cough and Chest Congestion DM syrup orally (not to exceed 6 doses in any 24-hour period) for up to 8 days or until resolution of symptoms, whichever occurred first. | |
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