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This study is designed to generate real world data from participants with nasal congestion acquired from common cold following treatment with a marketed nasal spray. The main purpose of this study is to evaluate the effectiveness of a nasal spray on quality of life (QoL) factors.
This is a longitudinal, open-label study evaluating the effect on QoL factors in participants with the common cold using Otrivine nasal spray (xylometazoline hydrochloride 0.1 percent [%]), in a real-world setting. A sufficient number of adults aged 18 years and over with symptoms of common cold will be screened for eligibility. The study expects to enroll approximately 125 participants to ensure that 100 participants complete the study. All study data will be collected remotely through a study app using the participant's own mobile device.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Otrivine Congestion Relief | Experimental | Participants will be instructed to use the product per label and leaflet instructions: 1 spray in each nostril up to 3 times per day until resolution of symptoms or up to a maximum of 7 days, whichever occurs first. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Otrivine Congestion Relief | Drug | 0.1% Nasal Spray (Xylometazoline Hydrochloride) |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) Total Score | The WURSS is 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 is the short version of this validated survey. Participants rated their cold symptoms and QoL related questions using WURSS-21. It consisted of 10 symptoms questions and 9 QoL questions, the responses of which 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. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value. A negative change from Baseline indicated improvement in symptoms and quality of life. | Baseline (Day 0) up to Day 7 |
| Change From Baseline in WURSS-21 Total Symptom Domains Score | The WURSS is 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 is the short version of this validated survey. The symptom domain of WURSS-21 consisted of 10 questions. Participants rated their cold symptoms related questions, the responses of which were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptoms and 7=Severely. Thus, the minimum and maximum possible total score were 0 and 70 respectively, where higher scores indicated a negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value. A negative change from Baseline indicated improvement of symptoms. | Baseline (Day 0) up to Day 7 |
| Change From Baseline in WURSS-21 Total QoL Domains Score | The WURSS is 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 is the short version of this validated survey. The QoL domain of WURSS-21 consisted of 9 questions. Participants rated their QoL related questions, the responses of which 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 a negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value. A negative change from Baseline indicated improvement of quality of life. |
| Measure | Description | Time Frame |
|---|---|---|
| Post Otrivine Use Score for Additional Health Related QoL Factors: Snoring | Health related QoL factors were assessed using questions related to snoring, alertness, self-consciousness about how participants sound, smell, taste, self-consciousness around people, 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. The minimum and maximum score for each question was 0 and 7 respectively, where lower score indicated improvement. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The VCTC | Swadlincote | Derbyshire | DE11 7AQ | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38372128 | Derived | Hagen M, Clark K, Kalita P, Serra G, Sanchez E, Varbiro G, Albasser MM. A real-world study of quality of life following treatment with xylometazoline hydrochloride in individuals with common cold. Ther Adv Respir Dis. 2024 Jan-Dec;18:17534666241228927. doi: 10.1177/17534666241228927. |
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Anonymized individual participant data and study documents can be requested for further research from ww.clinical-trial-register@haleon.com
IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension can be granted, when justified, for up to another 12 months.
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A total of 172 participants were screened of which 136 were enrolled and 100 completed the study. A total of 36 participants were discontinued from the study.
This was a decentralized study in participants with common cold using Otrivine nasal spray (xylometazoline hydrochloride 0.1 percent [%]), in a real-world setting. Participants were recruited through targeted advertising on social media channels. All study data were collected remotely through a study app using the participant's own mobile device.
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| ID | Title | Description |
|---|---|---|
| FG000 | Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Participants were instructed to use Otrivine congestion relief 0.1% nasal spray (xylometazoline hydrochloride) per label and leaflet instructions. Participants administered 1 spray in each nostril up to 3 times per day until resolution of symptoms or up to a maximum of 7 days, whichever occurred first. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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The 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.
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| ID | Title | Description |
|---|---|---|
| BG000 | Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Participants were instructed to use Otrivine congestion relief 0.1% nasal spray (xylometazoline hydrochloride) per label and leaflet instructions. Participants administered 1 spray in each nostril up to 3 times per day until resolution of symptoms or up to a maximum of 7 days, whichever occurred first. |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Change From Baseline in Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) Total Score | The WURSS is 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 is the short version of this validated survey. Participants rated their cold symptoms and QoL related questions using WURSS-21. It consisted of 10 symptoms questions and 9 QoL questions, the responses of which 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. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value. A negative change from Baseline indicated improvement in symptoms and quality of life. | The 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 indicated timepoints were analyzed. | Posted | Mean | Standard Deviation | score on a scale | Baseline (Day 0) up to Day 7 |
From first dose of study product administration up to Day 7
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). All-Cause Mortality included all randomized participants. Serious and Other AEs: Safety population included all participants who used study product at least once.
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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 | Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) | Participants were instructed to use Otrivine congestion relief 0.1% nasal spray (xylometazoline hydrochloride) per label and leaflet instructions. Participants administered 1 spray in each nostril up to 3 times per day until resolution of symptoms or up to a maximum of 7 days, whichever occured first. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA version 25.1. | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Haleon Response Center | HALEON | +441932959500 | ww.clinical-trial-register@haleon.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 7, 2022 | Nov 29, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 4, 2023 | Dec 6, 2023 | SAP_001.pdf |
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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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| Baseline (Day 0) up to Day 7 |
| Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Runny Nose | The WURSS is 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 is 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, the responses of which were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severely. Thus, the minimum and maximum score for each symptom domain question were 0 and 7, where higher scores indicated a negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value. A negative change from Baseline indicated improvement in symptom. | Baseline (Day 0) up to Day 7 |
| Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Plugged Nose | The WURSS is 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 is 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, the responses of which were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severely. Thus, the minimum and maximum score for each symptom domain question were 0 and 7, where higher scores indicated a negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value. A negative change from Baseline indicated improvement in symptom. | Baseline (Day 0) up to Day 7 |
| Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Sneezing | The WURSS is 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 is 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, the responses of which were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severely. Thus, the minimum and maximum score for each symptom domain question were 0 and 7, where higher scores indicated a negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value. A negative change from Baseline indicated improvement in symptom. | Baseline (Day 0) up to Day 7 |
| Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Sore Throat | The WURSS is 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 is 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, the responses of which were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severely. Thus, the minimum and maximum score for each symptom domain question were 0 and 7, where higher scores indicated a negative impact on each individual symptom. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value. A negative change from Baseline indicated improvement in symptoms. | Baseline (Day 0) up to Day 7 |
| Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Scratchy Throat | The WURSS is 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 is 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, the responses of which were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severely. Thus, the minimum and maximum score for each symptom domain question were 0 and 7, where higher scores indicated a negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value. A negative change from Baseline indicated improvement in symptom. | Baseline (Day 0) up to Day 7 |
| Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Cough | The WURSS is 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 is 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, the responses of which were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severely. Thus, the minimum and maximum score for each symptom domain question were 0 and 7, where higher scores indicated a negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value. A negative change from Baseline indicated improvement in symptom. | Baseline (Day 0) up to Day 7 |
| Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Hoarseness | The WURSS is 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 is 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, the responses of which were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severely. Thus, the minimum and maximum score for each symptom domain question were 0 and 7, where higher scores indicated a negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value. A negative change from Baseline indicated improvement in symptom. | Baseline (Day 0) up to Day 7 |
| Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Head Congestion | The WURSS is 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 is 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, the responses of which were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severely. Thus, the minimum and maximum score for each symptom domain question were 0 and 7, where higher scores indicated a negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value. A negative change from Baseline indicated improvement in symptom. | Baseline (Day 0) up to Day 7 |
| Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Chest Congestion | The WURSS is 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 is 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, the responses of which were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severely. Thus, the minimum and maximum score for each symptom domain question were 0 and 7, where higher scores indicated a negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value. A negative change from Baseline indicated improvement in symptom. | Baseline (Day 0) up to Day 7 |
| Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Feeling Tired | The WURSS is 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 is 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, the responses of which were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severely. Thus, the minimum and maximum score for each symptom domain question were 0 and 7, where higher scores indicated a negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value. A negative change from Baseline indicated improvement in symptom. | Baseline (Day 0) up to Day 7 |
| Days 1, 2, 3, 4, 5, 6, and 7 |
| Post Otrivine Use Score for Additional Health Related QoL Factors: Alertness | Health related QoL factors were assessed using questions related to snoring, alertness, self-consciousness about how participants sound, smell, taste, self-consciousness around people, 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. The minimum and maximum score for each question was 0 and 7 respectively, where lower score indicated improvement. | Days 1, 2, 3, 4, 5, 6, and 7 |
| Post Otrivine Use Score for Additional Health Related QoL Factors: Self-conscious About Sound | Health related QoL factors were assessed using questions related to snoring, alertness, self-consciousness about how participants sound, smell, taste, self-consciousness around people, 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. The minimum and maximum score for each question was 0 and 7 respectively, where lower score indicated improvement. | Days 1, 2, 3, 4, 5, 6, and 7 |
| Post Otrivine Use Score for Additional Health Related QoL Factors: Smell | Health related QoL factors were assessed using questions related to snoring, alertness, self-consciousness about how participants sound, smell, taste, self-consciousness around people, 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. The minimum and maximum score for each question was 0 and 7 respectively, where lower score indicated improvement. | Days 1, 2, 3, 4, 5, 6 and 7 |
| Post Otrivine Use Score for Additional Health Related QoL Factors: Taste | Health related QoL factors were assessed using questions related to snoring, alertness, self-consciousness about how participants sound, smell, taste, self-consciousness around people, 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. The minimum and maximum score for each question was 0 and 7 respectively, where lower score indicated improvement. | Days 1, 2, 3, 4, 5, 6 and 7 |
| Post Otrivine Use Score for Additional Health Related QoL Factors: Self-conscious Around People | Health related QoL factors were assessed using questions related to snoring, alertness, self-consciousness about how participants sound, smell, taste, self-consciousness around people, 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. The minimum and maximum score for each question was 0 and 7 respectively, where lower score indicated improvement. | Day 1, 2, 3, 4, 5, 6 and 7 |
| Post Otrivine Use Score for Additional Health Related QoL Factors: Energy | Health related QoL factors were assessed using questions related to snoring, alertness, self-consciousness about how participants sound, smell, taste, self-consciousness around people, 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. The minimum and maximum score for each question was 0 and 7 respectively, where lower score indicated improvement. | Days 1, 2, 3, 4, 5, 6 and 7 |
| Post Otrivine Use Score for Additional Health Related QoL Factors: Motivation | Health related QoL factors were assessed using questions related to snoring, alertness, self-consciousness about how participants sound, smell, taste, self-consciousness around people, 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. The minimum and maximum score for each question was 0 and 7 respectively, where lower score indicated improvement. | Days 1, 2, 3, 4, 5, 6 and 7 |
| No Longer Wished to Participate |
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| Bacterial Conjunctivitis |
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| years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Primary | Change From Baseline in WURSS-21 Total Symptom Domains Score | The WURSS is 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 is the short version of this validated survey. The symptom domain of WURSS-21 consisted of 10 questions. Participants rated their cold symptoms related questions, the responses of which were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptoms and 7=Severely. Thus, the minimum and maximum possible total score were 0 and 70 respectively, where higher scores indicated a negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value. A negative change from Baseline indicated improvement of symptoms. | mITT population. Only those participants with data available at the indicated timepoints were analyzed. | Posted | Mean | Standard Deviation | score on a scale | Baseline (Day 0) up to Day 7 |
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| Primary | Change From Baseline in WURSS-21 Total QoL Domains Score | The WURSS is 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 is the short version of this validated survey. The QoL domain of WURSS-21 consisted of 9 questions. Participants rated their QoL related questions, the responses of which 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 a negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value. A negative change from Baseline indicated improvement of quality of life. | mITT population. Only those participants with data available at the indicated timepoints were analyzed. | Posted | Mean | Standard Deviation | score on a scale | Baseline (Day 0) up to Day 7 |
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| Primary | Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Runny Nose | The WURSS is 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 is 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, the responses of which were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severely. Thus, the minimum and maximum score for each symptom domain question were 0 and 7, where higher scores indicated a negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value. A negative change from Baseline indicated improvement in symptom. | mITT population. Only those participants with data available at the indicated timepoints were analyzed. | Posted | Mean | Standard Deviation | score on a scale | Baseline (Day 0) up to Day 7 |
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| Primary | Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Plugged Nose | The WURSS is 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 is 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, the responses of which were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severely. Thus, the minimum and maximum score for each symptom domain question were 0 and 7, where higher scores indicated a negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value. A negative change from Baseline indicated improvement in symptom. | mITT population. Only those participants with data available at the indicated timepoints were analyzed. | Posted | Mean | Standard Deviation | score on a scale | Baseline (Day 0) up to Day 7 |
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| Primary | Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Sneezing | The WURSS is 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 is 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, the responses of which were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severely. Thus, the minimum and maximum score for each symptom domain question were 0 and 7, where higher scores indicated a negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value. A negative change from Baseline indicated improvement in symptom. | mITT population. Only those participants with data available at the indicated timepoints were analyzed. | Posted | Mean | Standard Deviation | score on a scale | Baseline (Day 0) up to Day 7 |
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| Primary | Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Sore Throat | The WURSS is 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 is 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, the responses of which were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severely. Thus, the minimum and maximum score for each symptom domain question were 0 and 7, where higher scores indicated a negative impact on each individual symptom. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value. A negative change from Baseline indicated improvement in symptoms. | mITT population. Only those participants with data available at the indicated timepoints were analyzed. | Posted | Mean | Standard Deviation | score on a scale | Baseline (Day 0) up to Day 7 |
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| Primary | Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Scratchy Throat | The WURSS is 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 is 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, the responses of which were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severely. Thus, the minimum and maximum score for each symptom domain question were 0 and 7, where higher scores indicated a negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value. A negative change from Baseline indicated improvement in symptom. | mITT population. Only those participants with data available at the indicated timepoints were analyzed. | Posted | Mean | Standard Deviation | score on a scale | Baseline (Day 0) up to Day 7 |
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| Primary | Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Cough | The WURSS is 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 is 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, the responses of which were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severely. Thus, the minimum and maximum score for each symptom domain question were 0 and 7, where higher scores indicated a negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value. A negative change from Baseline indicated improvement in symptom. | mITT population. Only those participants with data available at the indicated timepoints were analyzed. | Posted | Mean | Standard Deviation | score on a scale | Baseline (Day 0) up to Day 7 |
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| Primary | Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Hoarseness | The WURSS is 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 is 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, the responses of which were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severely. Thus, the minimum and maximum score for each symptom domain question were 0 and 7, where higher scores indicated a negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value. A negative change from Baseline indicated improvement in symptom. | mITT population. Only those participants with data available at the indicated timepoints were analyzed. | Posted | Mean | Standard Deviation | score on a scale | Baseline (Day 0) up to Day 7 |
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| Primary | Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Head Congestion | The WURSS is 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 is 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, the responses of which were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severely. Thus, the minimum and maximum score for each symptom domain question were 0 and 7, where higher scores indicated a negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value. A negative change from Baseline indicated improvement in symptom. | mITT population. Only those participants with data available at the indicated timepoints were analyzed. | Posted | Mean | Standard Deviation | score on a scale | Baseline (Day 0) up to Day 7 |
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| Primary | Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Chest Congestion | The WURSS is 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 is 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, the responses of which were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severely. Thus, the minimum and maximum score for each symptom domain question were 0 and 7, where higher scores indicated a negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value. A negative change from Baseline indicated improvement in symptom. | mITT population. Only those participants with data available at the indicated timepoints were analyzed. | Posted | Mean | Standard Deviation | score on a scale | Baseline (Day 0) up to Day 7 |
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| Primary | Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Feeling Tired | The WURSS is 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 is 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, the responses of which were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severely. Thus, the minimum and maximum score for each symptom domain question were 0 and 7, where higher scores indicated a negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value. A negative change from Baseline indicated improvement in symptom. | mITT population. Only those participants with data available at the indicated timepoints were analyzed. | Posted | Mean | Standard Deviation | score on a scale | Baseline (Day 0) up to Day 7 |
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| Secondary | Post Otrivine Use Score for Additional Health Related QoL Factors: Snoring | Health related QoL factors were assessed using questions related to snoring, alertness, self-consciousness about how participants sound, smell, taste, self-consciousness around people, 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. The minimum and maximum score for each question was 0 and 7 respectively, where lower score indicated improvement. | mITT population. Here, overall number analyzed is defined as the number of participants with data available for analysis for this outcome measure. Only those participants with data available at the indicated timepoints were analyzed. | Posted | Mean | Standard Deviation | score on a scale | Days 1, 2, 3, 4, 5, 6, and 7 |
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| Secondary | Post Otrivine Use Score for Additional Health Related QoL Factors: Alertness | Health related QoL factors were assessed using questions related to snoring, alertness, self-consciousness about how participants sound, smell, taste, self-consciousness around people, 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. The minimum and maximum score for each question was 0 and 7 respectively, where lower score indicated improvement. | mITT population. Here, overall number analyzed is defined as the number of participants with data available for analysis for this outcome measure. Only those participants with data available at the indicated timepoints were analyzed. | Posted | Mean | Standard Deviation | score on a scale | Days 1, 2, 3, 4, 5, 6, and 7 |
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| Secondary | Post Otrivine Use Score for Additional Health Related QoL Factors: Self-conscious About Sound | Health related QoL factors were assessed using questions related to snoring, alertness, self-consciousness about how participants sound, smell, taste, self-consciousness around people, 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. The minimum and maximum score for each question was 0 and 7 respectively, where lower score indicated improvement. | mITT population. Here, overall number analyzed is defined as the number of participants with data available for analysis for this outcome measure. Only those participants with data available at the indicated timepoints were analyzed. | Posted | Mean | Standard Deviation | score on a scale | Days 1, 2, 3, 4, 5, 6, and 7 |
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| Secondary | Post Otrivine Use Score for Additional Health Related QoL Factors: Smell | Health related QoL factors were assessed using questions related to snoring, alertness, self-consciousness about how participants sound, smell, taste, self-consciousness around people, 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. The minimum and maximum score for each question was 0 and 7 respectively, where lower score indicated improvement. | mITT population. Here, overall number analyzed is defined as the number of participants with data available for analysis for this outcome measure. Only those participants with data available at the indicated timepoints were analyzed. | Posted | Mean | Standard Deviation | score on a scale | Days 1, 2, 3, 4, 5, 6 and 7 |
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| Secondary | Post Otrivine Use Score for Additional Health Related QoL Factors: Taste | Health related QoL factors were assessed using questions related to snoring, alertness, self-consciousness about how participants sound, smell, taste, self-consciousness around people, 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. The minimum and maximum score for each question was 0 and 7 respectively, where lower score indicated improvement. | mITT population. Here, overall number analyzed is defined as the number of participants with data available for analysis for this outcome measure. Only those participants with data available at the indicated timepoints were analyzed. | Posted | Mean | Standard Deviation | score on a scale | Days 1, 2, 3, 4, 5, 6 and 7 |
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| Secondary | Post Otrivine Use Score for Additional Health Related QoL Factors: Self-conscious Around People | Health related QoL factors were assessed using questions related to snoring, alertness, self-consciousness about how participants sound, smell, taste, self-consciousness around people, 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. The minimum and maximum score for each question was 0 and 7 respectively, where lower score indicated improvement. | mITT population. Here, overall number analyzed is defined as the number of participants with data available for analysis for this outcome measure. Only those participants with data available at the indicated timepoints were analyzed. | Posted | Mean | Standard Deviation | score on a scale | Day 1, 2, 3, 4, 5, 6 and 7 |
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| Secondary | Post Otrivine Use Score for Additional Health Related QoL Factors: Energy | Health related QoL factors were assessed using questions related to snoring, alertness, self-consciousness about how participants sound, smell, taste, self-consciousness around people, 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. The minimum and maximum score for each question was 0 and 7 respectively, where lower score indicated improvement. | mITT population. Here, overall number analyzed is defined as the number of participants with data available for analysis for this outcome measure. Only those participants with data available at the indicated timepoints were analyzed. | Posted | Mean | Standard Deviation | score on a scale | Days 1, 2, 3, 4, 5, 6 and 7 |
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| Secondary | Post Otrivine Use Score for Additional Health Related QoL Factors: Motivation | Health related QoL factors were assessed using questions related to snoring, alertness, self-consciousness about how participants sound, smell, taste, self-consciousness around people, 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. The minimum and maximum score for each question was 0 and 7 respectively, where lower score indicated improvement. | mITT population. Here, overall number analyzed is defined as the number of participants with data available for analysis for this outcome measure. Only those participants with data available at the indicated timepoints were analyzed. | Posted | Mean | Standard Deviation | score on a scale | Days 1, 2, 3, 4, 5, 6 and 7 |
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|
|
| 0 |
| 136 |
| 0 |
| 102 |
| 6 |
| 102 |
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Eye Pruritus | Eye disorders | Systematic Assessment |
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| Lacrimation Increased | Eye disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Sinusitis | Infections and infestations | Systematic Assessment |
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HALEON agreements may vary with individual investigators but will not prohibit any investigator from publishing. HALEON 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 |
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| Change from Baseline at Day 2 |
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| Change from Baseline at Day 3 |
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|
| Change from Baseline at Day 4 |
|
|
| Change from Baseline at Day 5 |
|
|
| Change from Baseline at Day 6 |
|
|
| Change from Baseline at Day 7 |
|
|
| <.0001 |
| Mean Difference (Final Values) |
| -6.21 |
| 2-Sided |
| 95 |
| -8.51 |
| -3.92 |
| Other |
| Change from Baseline at Day 3 | Student's paired t-test | <.0001 | Mean Difference (Final Values) | -12.11 | 2-Sided | 95 | -15.00 | -9.22 | Other |
| Change from Baseline at Day 4 | Student's paired t-test | <.0001 | Mean Difference (Final Values) | -15.98 | 2-Sided | 95 | -19.24 | -12.71 | Other |
| Change from Baseline at Day 5 | Student's paired t-test | <.0001 | Mean Difference (Final Values) | -19.44 | 2-Sided | 95 | -23.29 | -15.59 | Other |
| Change from Baseline at Day 6 | Student's paired t-test | <.0001 | Mean Difference (Final Values) | -19.36 | 2-Sided | 95 | -24.03 | -14.69 | Other |
| Change from Baseline at Day 7 | Student's paired t-test | <.0001 | Mean Difference (Final Values) | -25.40 | 2-Sided | 95 | -31.87 | -18.93 | Other |
|
| Change From Baseline at Day 2 |
|
|
| Change From Baseline at Day 3 |
|
|
| Change From Baseline at Day 4 |
|
|
| Change From Baseline at Day 5 |
|
|
| Change From Baseline at Day 6 |
|
|
| Change From Baseline at Day 7 |
|
|
| <.0001 |
| Mean Difference (Final Values) |
| -9.14 |
| 2-Sided |
| 95 |
| -11.74 |
| -6.55 |
| Other |
| Change from Baseline at Day 3 | Student's paired t-test | <.0001 | Mean Difference (Final Values) | -15.16 | 2-Sided | 95 | -18.44 | -11.88 | Other |
| Change from Baseline at Day 4 | Student's paired t-test | <.0001 | Mean Difference (Final Values) | -19.07 | 2-Sided | 95 | -22.84 | -15.30 | Other |
| Change from Baseline at Day 5 | Student's paired t-test | <.0001 | Mean Difference (Final Values) | -19.05 | 2-Sided | 95 | -23.35 | -14.75 | Other |
| Change from Baseline at Day 6 | Student's paired t-test | <.0001 | Mean Difference (Final Values) | -20.31 | 2-Sided | 95 | -25.70 | -14.92 | Other |
| Change from Baseline at Day 7 | Student's paired t-test | <.0001 | Mean Difference (Final Values) | -27.20 | 2-Sided | 95 | -32.48 | -21.92 | Other |
|
| Change from Baseline at Day 2 |
|
|
| Change from Baseline at Day 3 |
|
|
| Change from Baseline at Day 4 |
|
|
| Change from Baseline at Day 5 |
|
|
| Change from Baseline at Day 6 |
|
|
| Change from Baseline at Day 7 |
|
|
| 0.0003 |
| Mean Difference (Final Values) |
| -0.63 |
| 2-Sided |
| 95 |
| -0.97 |
| -0.30 |
| Other |
| Change from Baseline at Day 3 | Student's paired t-test | <.0001 | Mean Difference (Final Values) | -1.10 | 2-Sided | 95 | -1.50 | -0.70 | Other |
| Change from Baseline at Day 4 | Student's paired t-test | <.0001 | Mean Difference (Final Values) | -1.72 | 2-Sided | 95 | -2.20 | -1.24 | Other |
| Change from Baseline at Day 5 | Student's paired t-test | <.0001 | Mean Difference (Final Values) | -1.75 | 2-Sided | 95 | -2.33 | -1.16 | Other |
| Change from Baseline at Day 6 | Student's paired t-test | <.0001 | Mean Difference (Final Values) | -1.90 | 2-Sided | 95 | -2.51 | -1.28 | Other |
| Change from Baseline at Day 7 | Student's paired t-test | <.0001 | Mean Difference (Final Values) | -2.47 | 2-Sided | 95 | -3.29 | -1.64 | Other |
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| Change From Baseline at Day 2 |
|
|
| Change From Baseline at Day 3 |
|
|
| Change From Baseline at Day 4 |
|
|
| Change From Baseline at Day 5 |
|
|
| Change From Baseline at Day 6 |
|
|
| Change From Baseline at Day 7 |
|
|
| <.0001 |
| Mean Difference (Final Values) |
| -1.47 |
| 2-Sided |
| 95 |
| -1.82 |
| -1.12 |
| Other |
| Change from Baseline at Day 3 | Student's paired t-test | <.0001 | Mean Difference (Final Values) | -1.99 | 2-Sided | 95 | -2.40 | -1.58 | Other |
| Change from Baseline at Day 4 | Student's paired t-test | <.0001 | Mean Difference (Final Values) | -2.43 | 2-Sided | 95 | -2.86 | -2.00 | Other |
| Change from Baseline at Day 5 | Student's paired t-test | <.0001 | Mean Difference (Final Values) | -3.00 | 2-Sided | 95 | -3.51 | -2.49 | Other |
| Change from Baseline at Day 6 | Student's paired t-test | <.0001 | Mean Difference (Final Values) | -2.77 | 2-Sided | 95 | -3.36 | -2.18 | Other |
| Change from Baseline at Day 7 | Student's paired t-test | <.0001 | Mean Difference (Final Values) | -3.33 | 2-Sided | 95 | -4.10 | -2.57 | Other |
|
| Change From Baseline at Day 2 |
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|
| Change From Baseline at Day 3 |
|
|
| Change From Baseline at Day 4 |
|
|
| Change From Baseline at Day 5 |
|
|
| Change From Baseline at Day 6 |
|
|
| Change From Baseline at Day 7 |
|
|
| <.0001 |
| Mean Difference (Final Values) |
| -0.87 |
| 2-Sided |
| 95 |
| -1.19 |
| -0.54 |
| Other |
| Change from Baseline at Day 3 | Student's paired t-test | <.0001 | Mean Difference (Final Values) | -1.21 | 2-Sided | 95 | -1.59 | -0.82 | Other |
| Change from Baseline at Day 4 | Student's paired t-test | <.0001 | Mean Difference (Final Values) | -1.59 | 2-Sided | 95 | -2.05 | -1.12 | Other |
| Change from Baseline at Day 5 | Student's paired t-test | <.0001 | Mean Difference (Final Values) | -1.86 | 2-Sided | 95 | -2.40 | -1.33 | Other |
| Change from Baseline at Day 6 | Student's paired t-test | <.0001 | Mean Difference (Final Values) | -1.85 | 2-Sided | 95 | -2.45 | -1.24 | Other |
| Change from Baseline at Day 7 | Student's paired t-test | <.0001 | Mean Difference (Final Values) | -2.47 | 2-Sided | 95 | -3.19 | -1.75 | Other |
|
| Change from Baseline to Day 2 |
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|
| Change from Baseline to Day 3 |
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|
| Change from Baseline to Day 4 |
|
|
| Change from Baseline to Day 5 |
|
|
| Change from Baseline to Day 6 |
|
|
| Change from Baseline to Day 7 |
|
|
| 0.0016 |
| Mean Difference (Final Values) |
| -0.61 |
| 2-Sided |
| 95 |
| -0.99 |
| -0.24 |
| Other |
| Change from Baseline at Day 3 | Student's paired t-test | <.0001 | Mean Difference (Final Values) | -1.23 | 2-Sided | 95 | -1.67 | -0.79 | Other |
| Change from Baseline at Day 4 | Student's paired t-test | <.0001 | Mean Difference (Final Values) | -1.67 | 2-Sided | 95 | -2.18 | -1.16 | Other |
| Change from Baseline at Day 5 | Student's paired t-test | <.0001 | Mean Difference (Final Values) | -1.98 | 2-Sided | 95 | -2.46 | -1.51 | Other |
| Change from Baseline at Day 6 | Student's paired t-test | <.0001 | Mean Difference (Final Values) | -2.08 | 2-Sided | 95 | -2.77 | -1.39 | Other |
| Change from Baseline at Day 7 | Student's paired t-test | <.0001 | Mean Difference (Final Values) | -2.87 | 2-Sided | 95 | -3.65 | -2.08 | Other |
|
| Change from Baseline at Day 2 |
|
|
| Change from Baseline at Day 3 |
|
|
| Change from Baseline at Day 4 |
|
|
| Change from Baseline at Day 5 |
|
|
| Change from Baseline at Day 6 |
|
|
| Change from Baseline at Day 7 |
|
|
| 0.0005 |
| Mean Difference (Final Values) |
| -0.67 |
| 2-Sided |
| 95 |
| -1.05 |
| -0.30 |
| Other |
| Change from Baseline at Day 3 | Student's paired t-test | <.0001 | Mean Difference (Final Values) | -1.29 | 2-Sided | 95 | -1.69 | -0.89 | Other |
| Change from Baseline at Day 4 | Student's paired t-test | <.0001 | Mean Difference (Final Values) | -1.41 | 2-Sided | 95 | -1.86 | -0.97 | Other |
| Change from Baseline at Day 5 | Student's paired t-test | <.0001 | Mean Difference (Final Values) | -1.98 | 2-Sided | 95 | -2.50 | -1.47 | Other |
| Change from Baseline at Day 6 | Student's paired t-test | <.0001 | Mean Difference (Final Values) | -1.95 | 2-Sided | 95 | -2.61 | -1.29 | Other |
| Change from Baseline at Day 7 | Student's paired t-test | <.0001 | Mean Difference (Final Values) | -2.40 | 2-Sided | 95 | -3.26 | -1.54 | Other |
|
| Change from Baseline at Day 2 |
|
|
| Change from Baseline at Day 3 |
|
|
| Change from Baseline at Day 4 |
|
|
| Change from Baseline at Day 5 |
|
|
| Change from Baseline at Day 6 |
|
|
| Change from Baseline at Day 7 |
|
|
| 0.0313 |
| Mean Difference (Final Values) |
| -0.41 |
| 2-Sided |
| 95 |
| -0.78 |
| -0.04 |
| Other |
| Change from Baseline at Day 3 | Student's paired t-test | 0.0003 | Mean Difference (Final Values) | -0.84 | 2-Sided | 95 | -1.28 | -0.39 | Other |
| Change from Baseline at Day 4 | Student's paired t-test | <.0001 | Mean Difference (Final Values) | -1.05 | 2-Sided | 95 | -1.51 | -0.59 | Other |
| Change from Baseline at Day 5 | Student's paired t-test | <.0001 | Mean Difference (Final Values) | -1.20 | 2-Sided | 95 | -1.74 | -0.66 | Other |
| Change from Baseline at Day 6 | Student's paired t-test | 0.0018 | Mean Difference (Final Values) | -1.05 | 2-Sided | 95 | -1.69 | -0.42 | Other |
| Change from Baseline at Day 7 | Student's paired t-test | 0.0041 | Mean Difference (Final Values) | -1.27 | 2-Sided | 95 | -2.10 | -0.43 | Other |
|
| Change from Baseline at Day 2 |
|
|
| Change from Baseline at Day 3 |
|
|
| Change from Baseline at Day 4 |
|
|
| Change from Baseline at Day 5 |
|
|
| Change from Baseline at Day 6 |
|
|
| Change from Baseline at Day 7 |
|
|
| 0.0416 |
| Mean Difference (Final Values) |
| -0.37 |
| 2-Sided |
| 95 |
| -0.72 |
| -0.01 |
| Other |
| Change from Baseline at Day 3 | Student's paired t-test | <.0001 | Mean Difference (Final Values) | -0.96 | 2-Sided | 95 | -1.29 | -0.62 | Other |
| Change from Baseline at Day 4 | Student's paired t-test | <.0001 | Mean Difference (Final Values) | -1.18 | 2-Sided | 95 | -1.60 | -0.76 | Other |
| Change from Baseline at Day 5 | Student's paired t-test | <.0001 | Mean Difference (Final Values) | -1.76 | 2-Sided | 95 | -2.25 | -1.27 | Other |
| Change from Baseline at Day 6 | Student's paired t-test | <.0001 | Mean Difference (Final Values) | -1.69 | 2-Sided | 95 | -2.33 | -1.05 | Other |
| Change from Baseline at Day 7 | Student's paired t-test | <.0001 | Mean Difference (Final Values) | -2.30 | 2-Sided | 95 | -3.08 | -1.52 | Other |
|
| Change from Baseline at Day 2 |
|
|
| Change from Baseline at Day 3 |
|
|
| Change from Baseline at Day 4 |
|
|
| Change from Baseline at Day 5 |
|
|
| Change from Baseline at Day 6 |
|
|
| Change from Baseline at Day 7 |
|
|
| <.0001 |
| Mean Difference (Final Values) |
| -0.77 |
| 2-Sided |
| 95 |
| -1.14 |
| -0.39 |
| Other |
| Change from Baseline at Day 3 | Student's paired t-test | <.0001 | Mean Difference (Final Values) | -1.62 | 2-Sided | 95 | -2.05 | -1.19 | Other |
| Change from Baseline at Day 4 | Student's paired t-test | <.0001 | Mean Difference (Final Values) | -2.29 | 2-Sided | 95 | -2.73 | -1.86 | Other |
| Change from Baseline at Day 5 | Student's paired t-test | <.0001 | Mean Difference (Final Values) | -2.46 | 2-Sided | 95 | -2.98 | -1.94 | Other |
| Change from Baseline at Day 6 | Student's paired t-test | <.0001 | Mean Difference (Final Values) | -2.64 | 2-Sided | 95 | -3.36 | -1.92 | Other |
| Change from Baseline at Day 7 | Student's paired t-test | <.0001 | Mean Difference (Final Values) | -3.20 | 2-Sided | 95 | -4.19 | -2.21 | Other |
|
| Change from Baseline at Day 2 |
|
|
| Change from Baseline at Day 3 |
|
|
| Change from Baseline at Day 4 |
|
|
| Change from Baseline at Day 5 |
|
|
| Change from Baseline at Day 6 |
|
|
| Change from Baseline at Day 7 |
|
|
| 0.6460 |
| Mean Difference (Final Values) |
| -0.07 |
| 2-Sided |
| 95 |
| -0.38 |
| 0.24 |
| Other |
| Change from Baseline at Day 3 | Student's paired t-test | 0.0021 | Mean Difference (Final Values) | -0.59 | 2-Sided | 95 | -0.95 | -0.22 | Other |
| Change from Baseline at Day 4 | Student's paired t-test | 0.0002 | Mean Difference (Final Values) | -0.83 | 2-Sided | 95 | -1.25 | -0.41 | Other |
| Change from Baseline at Day 5 | Student's paired t-test | <.0001 | Mean Difference (Final Values) | -1.20 | 2-Sided | 95 | -1.68 | -0.73 | Other |
| Change from Baseline at Day 6 | Student's paired t-test | 0.0003 | Mean Difference (Final Values) | -1.36 | 2-Sided | 95 | -2.04 | -0.68 | Other |
| Change from Baseline at Day 7 | Student's paired t-test | <.0001 | Mean Difference (Final Values) | -2.13 | 2-Sided | 95 | -2.95 | -1.32 | Other |
|
| Change from Baseline at Day 2 |
|
|
| Change from Baseline at Day 3 |
|
|
| Change from Baseline at Day 4 |
|
|
| Change from Baseline at Day 5 |
|
|
| Change from Baseline at Day 6 |
|
|
| Change from Baseline at Day 7 |
|
|
| 0.0364 |
| Mean Difference (Final Values) |
| -0.35 |
| 2-Sided |
| 95 |
| -0.67 |
| -0.02 |
| Other |
| Change from Baseline at Day 3 | Student's paired t-test | <.0001 | Mean Difference (Final Values) | -1.29 | 2-Sided | 95 | -1.68 | -0.91 | Other |
| Change from Baseline at Day 4 | Student's paired t-test | <.0001 | Mean Difference (Final Values) | -1.80 | 2-Sided | 95 | -2.25 | -1.36 | Other |
| Change from Baseline at Day 5 | Student's paired t-test | <.0001 | Mean Difference (Final Values) | -2.24 | 2-Sided | 95 | -2.78 | -1.69 | Other |
| Change from Baseline at Day 6 | Student's paired t-test | <.0001 | Mean Difference (Final Values) | -2.08 | 2-Sided | 95 | -2.70 | -1.45 | Other |
| Change from Baseline at Day 7 | Student's paired t-test | <.0001 | Mean Difference (Final Values) | -2.97 | 2-Sided | 95 | -3.84 | -2.10 | Other |
|
| Day 3 |
|
|
| Day 4 |
|
|
| Day 5 |
|
|
| Day 6 |
|
|
| Day 7 |
|
|
| <.0001 |
| Mean Difference (Final Values) |
| -2.45 |
| 2-Sided |
| 95 |
| -2.90 |
| -2.01 |
| Other |
| Day 3 | Student's paired t-test | <.0001 | Mean Difference (Final Values) | -2.90 | 2-Sided | 95 | -3.41 | -2.39 | Other |
| Day 4 | Student's paired t-test | <.0001 | Mean Difference (Final Values) | -3.30 | 2-Sided | 95 | -3.82 | -2.77 | Other |
| Day 5 | Student's paired t-test | <.0001 | Mean Difference (Final Values) | -2.95 | 2-Sided | 95 | -3.53 | -2.37 | Other |
| Day 6 | Student's paired t-test | <.0001 | Mean Difference (Final Values) | -3.26 | 2-Sided | 95 | -3.98 | -2.53 | Other |
| Day 7 | Student's paired t-test | <.0001 | Mean Difference (Final Values) | -3.12 | 2-Sided | 95 | -4.08 | -2.16 | Other |
|
| Day 3 |
|
|
| Day 4 |
|
|
| Day 5 |
|
|
| Day 6 |
|
|
| Day 7 |
|
|
| <.0001 |
| Mean Difference (Final Values) |
| -2.12 |
| 2-Sided |
| 95 |
| -2.55 |
| -1.70 |
| Other |
| Day 3 | Student's paired t-test | <.0001 | Mean Difference (Final Values) | -2.30 | 2-Sided | 95 | -2.71 | -1.90 | Other |
| Day 4 | Student's paired t-test | <.0001 | Mean Difference (Final Values) | -2.76 | 2-Sided | 95 | -3.23 | -2.29 | Other |
| Day 5 | Student's paired t-test | <.0001 | Mean Difference (Final Values) | -2.85 | 2-Sided | 95 | -3.31 | -2.39 | Other |
| Day 6 | Student's paired t-test | <.0001 | Mean Difference (Final Values) | -3.18 | 2-Sided | 95 | -3.72 | -2.64 | Other |
| Day 7 | Student's paired t-test | <.0001 | Mean Difference (Final Values) | -3.17 | 2-Sided | 95 | -3.90 | -2.43 | Other |
|
| Day 3 |
|
|
| Day 4 |
|
|
| Day 5 |
|
|
| Day 6 |
|
|
| Day 7 |
|
|
| <.0001 |
| Mean Difference (Final Values) |
| -2.24 |
| 2-Sided |
| 95 |
| -2.66 |
| -1.81 |
| Other |
| Day 3 | Student's paired t-test | <.0001 | Mean Difference (Final Values) | -2.73 | 2-Sided | 95 | -3.14 | -2.32 | Other |
| Day 4 | Student's paired t-test | <.0001 | Mean Difference (Final Values) | -2.91 | 2-Sided | 95 | -3.40 | -2.43 | Other |
| Day 5 | Student's paired t-test | <.0001 | Mean Difference (Final Values) | -3.17 | 2-Sided | 95 | -3.68 | -2.66 | Other |
| Day 6 | Student's paired t-test | <.0001 | Mean Difference (Final Values) | -3.28 | 2-Sided | 95 | -4.02 | -2.54 | Other |
| Day 7 | Student's paired t-test | <.0001 | Mean Difference (Final Values) | -3.47 | 2-Sided | 95 | -4.24 | -2.70 | Other |
|
| Day 3 |
|
|
| Day 4 |
|
|
| Day 5 |
|
|
| Day 6 |
|
|
| Day 7 |
|
|
| <.0001 |
| Mean Difference (Final Values) |
| -2.42 |
| 2-Sided |
| 95 |
| -2.83 |
| -2.01 |
| Other |
| Day 3 | Student's paired t-test | <.0001 | Mean Difference (Final Values) | -2.97 | 2-Sided | 95 | -3.41 | -2.53 | Other |
| Day 4 | Student's paired t-test | <.0001 | Mean Difference (Final Values) | -3.34 | 2-Sided | 95 | -3.81 | -2.87 | Other |
| Day 5 | Student's paired t-test | <.0001 | Mean Difference (Final Values) | -3.36 | 2-Sided | 95 | -3.84 | -2.87 | Other |
| Change from Baseline at Day 6 | Student's paired t-test | <.0001 | Mean Difference (Final Values) | -3.23 | 2-Sided | 95 | -3.91 | -2.56 | Other |
| Day 7 | Student's paired t-test | <.0001 | Mean Difference (Final Values) | -3.70 | 2-Sided | 95 | -4.48 | -2.92 | Other |
|
| Day 3 |
|
|
| Day 4 |
|
|
| Day 5 |
|
|
| Day 6 |
|
|
| Day 7 |
|
|
| <.0001 |
| Mean Difference (Final Values) |
| -2.09 |
| 2-Sided |
| 95 |
| -2.51 |
| -1.67 |
| Other |
| Day 3 | Student's paired t-test | <.0001 | Mean Difference (Final Values) | -2.41 | 2-Sided | 95 | -2.86 | -1.97 | Other |
| Day 4 | Student's paired t-test | <.0001 | Mean Difference (Final Values) | -2.74 | 2-Sided | 95 | -3.22 | -2.27 | Other |
| Day 5 | Student's paired t-test | <.0001 | Mean Difference (Final Values) | -2.73 | 2-Sided | 95 | -3.30 | -2.16 | Other |
| Day 6 | Student's paired t-test | <.0001 | Mean Difference (Final Values) | -2.87 | 2-Sided | 95 | -3.56 | -2.19 | Other |
| Day 7 | Student's paired t-test | <.0001 | Mean Difference (Final Values) | -3.20 | 2-Sided | 95 | -4.01 | -2.39 | Other |
|
| Day 3 |
|
|
| Day 4 |
|
|
| Day 5 |
|
|
| Day 6 |
|
|
| Day 7 |
|
|
| <.0001 |
| Mean Difference (Final Values) |
| -2.60 |
| 2-Sided |
| 95 |
| -3.00 |
| -2.20 |
| Other |
| Day 3 | Student's paired t-test | <.0001 | Mean Difference (Final Values) | -2.65 | 2-Sided | 95 | -3.09 | -2.22 | Other |
| Day 4 | Student's paired t-test | <.0001 | Mean Difference (Final Values) | -3.07 | 2-Sided | 95 | -3.53 | -2.62 | Other |
| Day 5 | Student's paired t-test | <.0001 | Mean Difference (Final Values) | -3.25 | 2-Sided | 95 | -3.76 | -2.75 | Other |
| Day 6 | Student's paired t-test | <.0001 | Mean Difference (Final Values) | -3.41 | 2-Sided | 95 | -4.04 | -2.78 | Other |
| Day 7 | Student's paired t-test | <.0001 | Mean Difference (Final Values) | -3.47 | 2-Sided | 95 | -4.30 | -2.64 | Other |
|
| Day 3 |
|
|
| Day 4 |
|
|
| Day 5 |
|
|
| Day 6 |
|
|
| Day 7 |
|
|
| <.0001 |
| Mean Difference (Final Values) |
| -2.76 |
| 2-Sided |
| 95 |
| -3.20 |
| -2.33 |
| Other |
| Day 3 | Student's paired t-test | <.0001 | Mean Difference (Final Values) | -3.21 | 2-Sided | 95 | -3.63 | -2.78 | Other |
| Day 4 | Student's paired t-test | <.0001 | Mean Difference (Final Values) | -3.49 | 2-Sided | 95 | -3.98 | -3.00 | Other |
| Day 5 | Student's paired t-test | <.0001 | Mean Difference (Final Values) | -3.83 | 2-Sided | 95 | -4.33 | -3.33 | Other |
| Day 6 | Student's paired t-test | <.0001 | Mean Difference (Final Values) | -4.05 | 2-Sided | 95 | -4.65 | -3.46 | Other |
| Day 7 | Student's paired t-test | <.0001 | Mean Difference (Final Values) | -4.13 | 2-Sided | 95 | -4.81 | -3.46 | Other |
|
| Day 3 |
|
|
| Day 4 |
|
|
| Day 5 |
|
|
| Day 6 |
|
|
| Day 7 |
|
|
| <.0001 |
| Mean Difference (Final Values) |
| -2.73 |
| 2-Sided |
| 95 |
| -3.15 |
| -2.31 |
| Other |
| Day 3 | Student's paired t-test | <.0001 | Mean Difference (Final Values) | -3.16 | 2-Sided | 95 | -3.60 | -2.73 | Other |
| Day 4 | Student's paired t-test | <.0001 | Mean Difference (Final Values) | -3.52 | 2-Sided | 95 | -4.00 | -3.05 | Other |
| Day 5 | Student's paired t-test | <.0001 | Mean Difference (Final Values) | -3.73 | 2-Sided | 95 | -4.19 | -3.27 | Other |
| Day 6 | Student's paired t-test | <.0001 | Mean Difference (Final Values) | -4.00 | 2-Sided | 95 | -4.55 | -3.45 | Other |
| Day 7 | Student's paired t-test | <.0001 | Mean Difference (Final Values) | -4.07 | 2-Sided | 95 | -4.74 | -3.39 | Other |