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To compare the clinical efficacy of levocetirizine 5 mg and montelukast 10 mg on symptoms of seasonal allergic rhinitis occurring in subjects exposed to ragweed pollen in an environmental exposure unit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo (PBO) | Placebo Comparator | Placebo was administered orally on Days 1 and 2. |
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| Montelukast (MLKT) | Experimental | 10 mg of Montelukast (MLKT) was administered orally on Days 1 and 2. |
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| Levocetirizine (LCTZ) | Experimental | 5 mg of Levocetirizine (LCTZ) was administered orally on Days 1 and 2. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Major Symptom Complex (MSC) Score Over Period I | Six individual symptoms which are most dominant in the rhinitis symptom profile will be combined to form the MSC severity score: Runny nose (right and left), itchy nose (right and left), sniffles, nose blows, sneezes, watery eyes. Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The total MSC score ranges from 0 - 36. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline. | Baseline, Treatment Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)] |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the MSC Score Over Period II | Six individual symptoms which are most dominant in the rhinitis symptom profile will be combined to form the MSC severity score: Runny nose (right and left), itchy nose (right and left), sniffles, nose blows, sneezes, watery eyes. Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The total MSC score ranges from 0 - 36. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| UCB Cares | UCB (+1 844 599 2273) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kingston | Ontario | Canada |
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| Label | URL |
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| FDA Safety Alerts and Recalls | View source |
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Participant Flow refers to the Randomized Set.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo (PBO) | Placebo was administered orally on Days 1 and 2. |
| FG001 | Levocetirizine (LCTZ) | 5 mg of Levocetirizine (LCTZ) was administered orally on Days 1 and 2. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Montelukast | Drug |
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| Levocetirizine | Drug |
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| Baseline, Treatment Period II [Day 2, from 9:30 am to 11:00 am] |
| Change From Baseline in the MSC Score Over Period III | Six individual symptoms which are most dominant in the rhinitis symptom profile will be combined to form the MSC severity score: Runny nose (right and left), itchy nose (right and left), sniffles, nose blows, sneezes, watery eyes. Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The total MSC score ranges from 0 - 36. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline. | Baseline, Treatment Period III [Day 2, from drug intake (at 11:00 am) to 3:30 pm] |
| Change From Baseline in the MSC Score Over the Total Treatment Period (Period I + Period II + Period III) | Six individual symptoms which are most dominant in the rhinitis symptom profile will be combined to form the MSC severity score: Runny nose (right and left), itchy nose (right and left), sniffles, nose blows, sneezes, watery eyes. Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The total MSC score ranges from 0 - 36. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline. | Baseline to Day 2 |
| Change From Baseline in the Total Symptom Complex (TSC) Score Over Period I | The TSC score was calculated as the sum of the following 10 individual symptom scores: runny nose (left and right), itchy nose (left and right), sniffles, nose blows, sneezes, watery eyes, itchy eyes and ears, itchy throat, cough and postnasal drip. Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The TSC score ranges from 0 to 56. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline. | Baseline, Treatment Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)] |
| Change From Baseline in the Total Symptom Complex (TSC) Score Over Period II | The TSC score was calculated as the sum of the following 10 individual symptom scores: runny nose (left and right), itchy nose (left and right), sniffles, nose blows, sneezes, watery eyes, itchy eyes and ears, itchy throat, cough and postnasal drip. Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The TSC score ranges from 0 to 56. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline. | Baseline, Treatment Period II [Day 2, from 9:30 am to 11:00 am] |
| Change From Baseline in the Total Symptom Complex (TSC) Score Over Period III | The TSC score was calculated as the sum of the following 10 individual symptom scores: runny nose (left and right), itchy nose (left and right), sniffles, nose blows, sneezes, watery eyes, itchy eyes and ears, itchy throat, cough and postnasal drip. Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The TSC score ranges from 0 to 56. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline. | Baseline, Treatment Period III [Day 2, from drug intake (at 11:00 am) to 3:30 pm] |
| Change From Baseline in the Total Symptom Complex (TSC) Score Over the Total Treatment Period (Period I + Period II + Period III) | The TSC score was calculated as the sum of the following 10 individual symptom scores: runny nose (left and right), itchy nose (left and right), sniffles, nose blows, sneezes, watery eyes, itchy eyes and ears, itchy throat, cough and postnasal drip. Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The TSC score ranges from 0 to 56. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline. | Baseline to Day 2 |
| Change From Baseline in the TSC Score + Nasal Congestion Score Over Period I | The TSC score was calculated as the sum of the following 10 individual symptom scores: runny nose (left and right), itchy nose (left and right), sniffles, nose blows, sneezes, watery eyes, itchy eyes and ears, itchy throat, cough and postnasal drip. Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The Nasal congestion score ranged from 0 to 4 (0 = clear, 1 = slight block, 2 = stuffy, 3 = very stuffy, 4 = blocked). It corresponds to the mean value of right nostril and left nostril. The TSC score plus Nasal congestion score was added and ranged from 0 to 60. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline. | Baseline, Treatment Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)] |
| Change From Baseline in the TSC Score + Nasal Congestion Score Over Period II | The TSC score was calculated as the sum of the following 10 individual symptom scores: runny nose (left and right), itchy nose (left and right), sniffles, nose blows, sneezes, watery eyes, itchy eyes and ears, itchy throat, cough and postnasal drip. Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The Nasal congestion score ranged from 0 to 4 (0 = clear, 1 = slight block, 2 = stuffy, 3 = very stuffy, 4 = blocked). It corresponds to the mean value of right nostril and left nostril. The TSC score plus Nasal congestion score was added and ranged from 0 to 60. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline. | Baseline, Treatment Period II [Day 2, from 9:30 am to 11:00 am] |
| Change From Baseline in the TSC Score + Nasal Congestion Score Over Period III | The TSC score was calculated as the sum of the following 10 individual symptom scores: runny nose (left and right), itchy nose (left and right), sniffles, nose blows, sneezes, watery eyes, itchy eyes and ears, itchy throat, cough and postnasal drip. Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The Nasal congestion score ranged from 0 to 4 (0 = clear, 1 = slight block, 2 = stuffy, 3 = very stuffy, 4 = blocked). It corresponds to the mean value of right nostril and left nostril. The TSC score plus Nasal congestion score was added and ranged from 0 to 60. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline. | Baseline, Treatment Period III [Day 2, from drug intake (at 11:00 am) to 3:30 pm] |
| Change From Baseline in the TSC Score + Nasal Congestion Score Over the Total Treatment Period (Period I + Period II + Period III) | The TSC score was calculated as the sum of the following 10 individual symptom scores: runny nose (left and right), itchy nose (left and right), sniffles, nose blows, sneezes, watery eyes, itchy eyes and ears, itchy throat, cough and postnasal drip. Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The Nasal congestion score ranged from 0 to 4 (0 = clear, 1 = slight block, 2 = stuffy, 3 = very stuffy, 4 = blocked). It corresponds to the mean value of right nostril and left nostril. The TSC score plus Nasal congestion score was added and ranged from 0 to 60. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline. | Baseline to Day 2 |
| Change From Baseline in the Individual Symptom Scores Over Period I | Individual symptom scores include Runny Nose Score, Itchy Nose Score, Sniffles Score, Postnasal Drip Score, Watery Eyes Score, Itchy Eyes and Ears Score, Itchy Throat Score, Cough Score, Sneezes Score, Nose Blows Score, Nasal Congestion Score. The subjects had to evaluate the severity of the symptoms using a scale from "None" to "Very severe" (ranging from 0 to 5). For Sneezes Score and Nose Blows Score, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The Nasal congestion score ranged from 0 to 4 (0 = clear, 1 = slight block, 2 = stuffy, 3 = very stuffy, 4 = blocked). It corresponds to the mean value of right nostril and left nostril. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline. | Baseline, Treatment Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)] |
| Change From Baseline in the Individual Symptom Scores Over Period II | Individual symptom scores include Runny Nose Score, Itchy Nose Score, Sniffles Score, Postnasal Drip Score, Watery Eyes Score, Itchy Eyes and Ears Score, Itchy Throat Score, Cough Score, Sneezes Score, Nose Blows Score, Nasal Congestion Score. The subjects had to evaluate the severity of the symptoms using a scale from "None" to "Very severe" (ranging from 0 to 5). For Sneezes Score and Nose Blows Score, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The Nasal congestion score ranged from 0 to 4 (0 = clear, 1 = slight block, 2 = stuffy, 3 = very stuffy, 4 = blocked). It corresponds to the mean value of right nostril and left nostril. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline. | Baseline, Treatment Period II [Day 2, from 9:30 am to 11:00 am] |
| Change From Baseline in the Individual Symptom Scores Over Period III | Individual symptom scores include Runny Nose Score, Itchy Nose Score, Sniffles Score, Postnasal Drip Score, Watery Eyes Score, Itchy Eyes and Ears Score, Itchy Throat Score, Cough Score, Sneezes Score, Nose Blows Score, Nasal Congestion Score. The subjects had to evaluate the severity of the symptoms using a scale from "None" to "Very severe" (ranging from 0 to 5). For Sneezes Score and Nose Blows Score, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The Nasal congestion score ranged from 0 to 4 (0 = clear, 1 = slight block, 2 = stuffy, 3 = very stuffy, 4 = blocked). It corresponds to the mean value of right nostril and left nostril. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline. | Baseline, Treatment Period III [Day 2, from drug intake (at 11:00 am) to 3:30 pm] |
| Change From Baseline in the Individual Symptom Scores Over the Total Treatment Period (Period I + Period II + Period III) | Individual symptom scores include Runny Nose Score, Itchy Nose Score, Sniffles Score, Postnasal Drip Score, Watery Eyes Score, Itchy Eyes and Ears Score, Itchy Throat Score, Cough Score, Sneezes Score, Nose Blows Score, Nasal Congestion Score. The subjects had to evaluate the severity of the symptoms using a scale from "None" to "Very severe" (ranging from 0 to 5). For Sneezes Score and Nose Blows Score, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The Nasal congestion score ranged from 0 to 4 (0 = clear, 1 = slight block, 2 = stuffy, 3 = very stuffy, 4 = blocked). It corresponds to the mean value of right nostril and left nostril. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline. | Baseline to Day 2 |
| Time to First Feeling of Improvement During Period I | During Period I, the subjects had to record the moment (hh:mm) of first feeling of improvement (compared to Baseline intensity of symptoms). | During Treatment Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)] |
| Onset of Action During Period I | The onset of action was defined as the first time point during Period I after initiation of the treatment when the reduction from Baseline in the MSC score for the active treatment group became statistically different from the placebo group and when this significant change was maintained for some period of time. | During Treatment Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)] |
| Intensity of Action From Baseline in the MSC Score Over Period I | The intensity of action was measured by the percentage of subjects with categorized percentage change from Baseline in the MSC score over Period I. Categories are defined as following: < 20%, >=20%, < 50%, >=50%, < 70%, >=70% change from Baseline. | Treatment Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)] |
| Intensity of Action From Baseline in the MSC Score Over Period II | The intensity of action was measured by the percentage of subjects with categorized percentage change from Baseline in the MSC score over Period II. Categories are defined as following: < 20%, >=20%, < 50%, >=50%, < 70%, >=70% change from Baseline. | Treatment Period II [Day 2, from 9:30 am to 11:00 am] |
| Intensity of Action From Baseline in the MSC Score Over Period III | The intensity of action was measured by the percentage of subjects with categorized percentage change from Baseline in the MSC score over Period III. Categories are defined as following: < 20%, >=20%, < 50%, >=50%, < 70%, >=70% change from Baseline. | Treatment Period III [Day 2, from drug intake (at 11:00 am) to 3:30 pm] |
| Variability of Action From Baseline in the MSC Score Over Period I | The variability of action was assessed by the percentage of distribution of the percentage change from Baseline in the MSC score. Categories are defined as following: < 20%, 20%-35%, 35%-50%, 50%-65%, 65%-80%, >=80%. | Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)] |
| Variability of Action From Baseline in the MSC Score Over Period II | The variability of action was assessed by the percentage of distribution of the percentage change from Baseline in the MSC score. Categories are defined as following: < 20%, 20%-35%, 35%-50%, 50%-65%, 65%-80%, >=80%. | Treatment Period II [Day 2, from 9:30 am to 11:00 am] |
| Variability of Action From Baseline in the MSC Score Over Period III | The variability of action was assessed by the percentage of distribution of the percentage change from Baseline in the MSC score. Categories are defined as following: < 20%, 20%-35%, 35%-50%, 50%-65%, 65%-80%, >=80%. | Treatment Period III [Day 2, from drug intake (at 11:00 am) to 3:30 pm] |
| Global Satisfaction of the Subjects at the End of Period III | Global satisfaction was evaluated at the end of Period III by the subject on a Visual Analog Scale (VAS) ranging from 0 (very dissatisfied) to 100 mm (very satisfied). | At the end of Period III (Day 2) |
| Percentage of Subjects, at the End of Period III Who Are Willing to Take the Same Medication During the Next Pollen Season | At the end of Period III, each subject without reference to the Symptom Diary Card (SDC) answered to the question: "Do you want to take the same treatment during the next pollen season?" (yes or no). | At the end of Period III (Day 2) |
| FG002 | Montelukast (MLKT) | 10 mg of Montelukast (MLKT) was administered orally on Days 1 and 2. |
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| NOT COMPLETED |
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Baseline Characteristics refer to the Intention-To-Treat (ITT) Set
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo (PBO) | Placebo was administered orally on Days 1 and 2. |
| BG001 | Levocetirizine (LCTZ) | 5 mg of Levocetirizine (LCTZ) was administered orally on Days 1 and 2. |
| BG002 | Montelukast (MLKT) | 10 mg of Montelukast (MLKT) was administered orally on Days 1 and 2. |
| BG003 | Total Title |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Change From Baseline in the Major Symptom Complex (MSC) Score Over Period I | Six individual symptoms which are most dominant in the rhinitis symptom profile will be combined to form the MSC severity score: Runny nose (right and left), itchy nose (right and left), sniffles, nose blows, sneezes, watery eyes. Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The total MSC score ranges from 0 - 36. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline. | Efficacy variables were analyzed using the Intention-To-Treat (ITT) population. ITT consists of all randomized subjects who took at least one dose of study medication. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Treatment Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)] |
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| Secondary | Change From Baseline in the MSC Score Over Period II | Six individual symptoms which are most dominant in the rhinitis symptom profile will be combined to form the MSC severity score: Runny nose (right and left), itchy nose (right and left), sniffles, nose blows, sneezes, watery eyes. Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The total MSC score ranges from 0 - 36. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline. | Only patients with valid MSC scores in Period II were included in the analysis. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Treatment Period II [Day 2, from 9:30 am to 11:00 am] |
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| Secondary | Change From Baseline in the MSC Score Over Period III | Six individual symptoms which are most dominant in the rhinitis symptom profile will be combined to form the MSC severity score: Runny nose (right and left), itchy nose (right and left), sniffles, nose blows, sneezes, watery eyes. Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The total MSC score ranges from 0 - 36. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline. | Only patients with valid MSC scores in Period III were included in the analysis. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Treatment Period III [Day 2, from drug intake (at 11:00 am) to 3:30 pm] |
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| Secondary | Change From Baseline in the MSC Score Over the Total Treatment Period (Period I + Period II + Period III) | Six individual symptoms which are most dominant in the rhinitis symptom profile will be combined to form the MSC severity score: Runny nose (right and left), itchy nose (right and left), sniffles, nose blows, sneezes, watery eyes. Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The total MSC score ranges from 0 - 36. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline. | Only patients with valid MSC scores during the Total Treatment Period were included in the analysis. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline to Day 2 |
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| Secondary | Change From Baseline in the Total Symptom Complex (TSC) Score Over Period I | The TSC score was calculated as the sum of the following 10 individual symptom scores: runny nose (left and right), itchy nose (left and right), sniffles, nose blows, sneezes, watery eyes, itchy eyes and ears, itchy throat, cough and postnasal drip. Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The TSC score ranges from 0 to 56. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline. | Only patients with valid TSC scores in Period I were included in the analysis. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Treatment Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)] |
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| Secondary | Change From Baseline in the Total Symptom Complex (TSC) Score Over Period II | The TSC score was calculated as the sum of the following 10 individual symptom scores: runny nose (left and right), itchy nose (left and right), sniffles, nose blows, sneezes, watery eyes, itchy eyes and ears, itchy throat, cough and postnasal drip. Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The TSC score ranges from 0 to 56. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline. | Only patients with valid TSC scores in Period II were included in the analysis. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Treatment Period II [Day 2, from 9:30 am to 11:00 am] |
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| Secondary | Change From Baseline in the Total Symptom Complex (TSC) Score Over Period III | The TSC score was calculated as the sum of the following 10 individual symptom scores: runny nose (left and right), itchy nose (left and right), sniffles, nose blows, sneezes, watery eyes, itchy eyes and ears, itchy throat, cough and postnasal drip. Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The TSC score ranges from 0 to 56. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline. | Only patients with valid TSC scores in Period III were included in the analysis. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Treatment Period III [Day 2, from drug intake (at 11:00 am) to 3:30 pm] |
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| Secondary | Change From Baseline in the Total Symptom Complex (TSC) Score Over the Total Treatment Period (Period I + Period II + Period III) | The TSC score was calculated as the sum of the following 10 individual symptom scores: runny nose (left and right), itchy nose (left and right), sniffles, nose blows, sneezes, watery eyes, itchy eyes and ears, itchy throat, cough and postnasal drip. Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The TSC score ranges from 0 to 56. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline. | Only patients with valid TSC scores during the Total Treatment Period were included in the analysis. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline to Day 2 |
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| Secondary | Change From Baseline in the TSC Score + Nasal Congestion Score Over Period I | The TSC score was calculated as the sum of the following 10 individual symptom scores: runny nose (left and right), itchy nose (left and right), sniffles, nose blows, sneezes, watery eyes, itchy eyes and ears, itchy throat, cough and postnasal drip. Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The Nasal congestion score ranged from 0 to 4 (0 = clear, 1 = slight block, 2 = stuffy, 3 = very stuffy, 4 = blocked). It corresponds to the mean value of right nostril and left nostril. The TSC score plus Nasal congestion score was added and ranged from 0 to 60. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline. | Only patients with valid TSC score + Nasal congestion score in Period I were included in the analysis. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Treatment Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)] |
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| Secondary | Change From Baseline in the TSC Score + Nasal Congestion Score Over Period II | The TSC score was calculated as the sum of the following 10 individual symptom scores: runny nose (left and right), itchy nose (left and right), sniffles, nose blows, sneezes, watery eyes, itchy eyes and ears, itchy throat, cough and postnasal drip. Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The Nasal congestion score ranged from 0 to 4 (0 = clear, 1 = slight block, 2 = stuffy, 3 = very stuffy, 4 = blocked). It corresponds to the mean value of right nostril and left nostril. The TSC score plus Nasal congestion score was added and ranged from 0 to 60. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline. | Only patients with valid TSC score + Nasal congestion score in Period II were included in the analysis. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Treatment Period II [Day 2, from 9:30 am to 11:00 am] |
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| Secondary | Change From Baseline in the TSC Score + Nasal Congestion Score Over Period III | The TSC score was calculated as the sum of the following 10 individual symptom scores: runny nose (left and right), itchy nose (left and right), sniffles, nose blows, sneezes, watery eyes, itchy eyes and ears, itchy throat, cough and postnasal drip. Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The Nasal congestion score ranged from 0 to 4 (0 = clear, 1 = slight block, 2 = stuffy, 3 = very stuffy, 4 = blocked). It corresponds to the mean value of right nostril and left nostril. The TSC score plus Nasal congestion score was added and ranged from 0 to 60. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline. | Only patients with valid TSC score + Nasal congestion score in Period III were included in the analysis. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Treatment Period III [Day 2, from drug intake (at 11:00 am) to 3:30 pm] |
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| Secondary | Change From Baseline in the TSC Score + Nasal Congestion Score Over the Total Treatment Period (Period I + Period II + Period III) | The TSC score was calculated as the sum of the following 10 individual symptom scores: runny nose (left and right), itchy nose (left and right), sniffles, nose blows, sneezes, watery eyes, itchy eyes and ears, itchy throat, cough and postnasal drip. Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The Nasal congestion score ranged from 0 to 4 (0 = clear, 1 = slight block, 2 = stuffy, 3 = very stuffy, 4 = blocked). It corresponds to the mean value of right nostril and left nostril. The TSC score plus Nasal congestion score was added and ranged from 0 to 60. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline. | Only patients with valid TSC score + Nasal congestion score during the Total Treatment Period were included in the analysis. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline to Day 2 |
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| Secondary | Change From Baseline in the Individual Symptom Scores Over Period I | Individual symptom scores include Runny Nose Score, Itchy Nose Score, Sniffles Score, Postnasal Drip Score, Watery Eyes Score, Itchy Eyes and Ears Score, Itchy Throat Score, Cough Score, Sneezes Score, Nose Blows Score, Nasal Congestion Score. The subjects had to evaluate the severity of the symptoms using a scale from "None" to "Very severe" (ranging from 0 to 5). For Sneezes Score and Nose Blows Score, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The Nasal congestion score ranged from 0 to 4 (0 = clear, 1 = slight block, 2 = stuffy, 3 = very stuffy, 4 = blocked). It corresponds to the mean value of right nostril and left nostril. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline. | Only patients with valid individual symptom scores in Period I were included in the analysis. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Treatment Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)] |
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| Secondary | Change From Baseline in the Individual Symptom Scores Over Period II | Individual symptom scores include Runny Nose Score, Itchy Nose Score, Sniffles Score, Postnasal Drip Score, Watery Eyes Score, Itchy Eyes and Ears Score, Itchy Throat Score, Cough Score, Sneezes Score, Nose Blows Score, Nasal Congestion Score. The subjects had to evaluate the severity of the symptoms using a scale from "None" to "Very severe" (ranging from 0 to 5). For Sneezes Score and Nose Blows Score, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The Nasal congestion score ranged from 0 to 4 (0 = clear, 1 = slight block, 2 = stuffy, 3 = very stuffy, 4 = blocked). It corresponds to the mean value of right nostril and left nostril. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline. | Only patients with valid individual symptom scores in Period II were included in the analysis. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Treatment Period II [Day 2, from 9:30 am to 11:00 am] |
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| Secondary | Change From Baseline in the Individual Symptom Scores Over Period III | Individual symptom scores include Runny Nose Score, Itchy Nose Score, Sniffles Score, Postnasal Drip Score, Watery Eyes Score, Itchy Eyes and Ears Score, Itchy Throat Score, Cough Score, Sneezes Score, Nose Blows Score, Nasal Congestion Score. The subjects had to evaluate the severity of the symptoms using a scale from "None" to "Very severe" (ranging from 0 to 5). For Sneezes Score and Nose Blows Score, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The Nasal congestion score ranged from 0 to 4 (0 = clear, 1 = slight block, 2 = stuffy, 3 = very stuffy, 4 = blocked). It corresponds to the mean value of right nostril and left nostril. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline. | Only patients with valid individual symptom scores in Period III were included in the analysis. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Treatment Period III [Day 2, from drug intake (at 11:00 am) to 3:30 pm] |
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| Secondary | Change From Baseline in the Individual Symptom Scores Over the Total Treatment Period (Period I + Period II + Period III) | Individual symptom scores include Runny Nose Score, Itchy Nose Score, Sniffles Score, Postnasal Drip Score, Watery Eyes Score, Itchy Eyes and Ears Score, Itchy Throat Score, Cough Score, Sneezes Score, Nose Blows Score, Nasal Congestion Score. The subjects had to evaluate the severity of the symptoms using a scale from "None" to "Very severe" (ranging from 0 to 5). For Sneezes Score and Nose Blows Score, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The Nasal congestion score ranged from 0 to 4 (0 = clear, 1 = slight block, 2 = stuffy, 3 = very stuffy, 4 = blocked). It corresponds to the mean value of right nostril and left nostril. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline. | Only patients with valid individual symptom scores during the Total Treatment Period were included in the analysis. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline to Day 2 |
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| Secondary | Time to First Feeling of Improvement During Period I | During Period I, the subjects had to record the moment (hh:mm) of first feeling of improvement (compared to Baseline intensity of symptoms). | Subjects with no first feeling of improvement were censored at 300 minutes. | Posted | Median | 95% Confidence Interval | minutes | During Treatment Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)] |
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| Secondary | Onset of Action During Period I | The onset of action was defined as the first time point during Period I after initiation of the treatment when the reduction from Baseline in the MSC score for the active treatment group became statistically different from the placebo group and when this significant change was maintained for some period of time. | Posted | Number | hours | During Treatment Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)] |
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| Secondary | Intensity of Action From Baseline in the MSC Score Over Period I | The intensity of action was measured by the percentage of subjects with categorized percentage change from Baseline in the MSC score over Period I. Categories are defined as following: < 20%, >=20%, < 50%, >=50%, < 70%, >=70% change from Baseline. | Posted | Number | percentage of participants | Treatment Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)] |
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| Secondary | Intensity of Action From Baseline in the MSC Score Over Period II | The intensity of action was measured by the percentage of subjects with categorized percentage change from Baseline in the MSC score over Period II. Categories are defined as following: < 20%, >=20%, < 50%, >=50%, < 70%, >=70% change from Baseline. | Posted | Number | percentage of participants | Treatment Period II [Day 2, from 9:30 am to 11:00 am] |
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| Secondary | Intensity of Action From Baseline in the MSC Score Over Period III | The intensity of action was measured by the percentage of subjects with categorized percentage change from Baseline in the MSC score over Period III. Categories are defined as following: < 20%, >=20%, < 50%, >=50%, < 70%, >=70% change from Baseline. | Posted | Number | percentage of participants | Treatment Period III [Day 2, from drug intake (at 11:00 am) to 3:30 pm] |
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| Secondary | Variability of Action From Baseline in the MSC Score Over Period I | The variability of action was assessed by the percentage of distribution of the percentage change from Baseline in the MSC score. Categories are defined as following: < 20%, 20%-35%, 35%-50%, 50%-65%, 65%-80%, >=80%. | Posted | Number | percentage of participants | Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)] |
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| Secondary | Variability of Action From Baseline in the MSC Score Over Period II | The variability of action was assessed by the percentage of distribution of the percentage change from Baseline in the MSC score. Categories are defined as following: < 20%, 20%-35%, 35%-50%, 50%-65%, 65%-80%, >=80%. | Posted | Number | percentage of participants | Treatment Period II [Day 2, from 9:30 am to 11:00 am] |
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| Secondary | Variability of Action From Baseline in the MSC Score Over Period III | The variability of action was assessed by the percentage of distribution of the percentage change from Baseline in the MSC score. Categories are defined as following: < 20%, 20%-35%, 35%-50%, 50%-65%, 65%-80%, >=80%. | Posted | Number | percentage of participants | Treatment Period III [Day 2, from drug intake (at 11:00 am) to 3:30 pm] |
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| Secondary | Global Satisfaction of the Subjects at the End of Period III | Global satisfaction was evaluated at the end of Period III by the subject on a Visual Analog Scale (VAS) ranging from 0 (very dissatisfied) to 100 mm (very satisfied). | Only subjects with valid data for Global Satisfaction (VAS Score) were included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | At the end of Period III (Day 2) |
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| Secondary | Percentage of Subjects, at the End of Period III Who Are Willing to Take the Same Medication During the Next Pollen Season | At the end of Period III, each subject without reference to the Symptom Diary Card (SDC) answered to the question: "Do you want to take the same treatment during the next pollen season?" (yes or no). | Only subjects with valid data were included in the analysis. | Posted | Number | percentage of participants | At the end of Period III (Day 2) |
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Adverse events were recorded in Study Phase II and in Study Phase III (Day 1 and Day 2), before and after each pollen exposure.
Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo (PBO) | Placebo was administered orally on Days 1 and 2. | 0 | 105 | 0 | 105 | 9 | 105 |
| EG001 | Levocetirizine (LCTZ) | 5 mg of Levocetirizine (LCTZ) was administered orally on Days 1 and 2. | 0 | 157 | 0 | 157 | 13 | 157 |
| EG002 | Montelukast (MLKT) | 10 mg of Montelukast (MLKT) was administered orally on Days 1 and 2. | 0 | 156 | 0 | 156 | 18 | 156 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ear pain | Ear and labyrinth disorders | MedDRA |
| ||
| Conjunctivitis | Eye disorders | MedDRA |
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| Eye pruritus | Eye disorders | MedDRA |
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| Eye swelling | Eye disorders | MedDRA |
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| Ocular hyperaemia | Eye disorders | MedDRA |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA |
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| Diarrhoea | Gastrointestinal disorders | MedDRA |
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| Nausea | Gastrointestinal disorders | MedDRA |
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| Vomiting | Gastrointestinal disorders | MedDRA |
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| Fatigue | General disorders | MedDRA |
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| Feeling hot | General disorders | MedDRA |
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| Cellulitis | Infections and infestations | MedDRA |
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| Conjunctivitis bacterial | Infections and infestations | MedDRA |
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| Upper respiratory tract infection | Infections and infestations | MedDRA |
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| Blood pressure increased | Investigations | MedDRA |
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| Body temperature increased | Investigations | MedDRA |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA |
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| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA |
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| Nodule on extremity | Musculoskeletal and connective tissue disorders | MedDRA |
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| Headache | Nervous system disorders | MedDRA |
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| Sinus headache | Nervous system disorders | MedDRA |
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| Somnolence | Nervous system disorders | MedDRA |
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| Anxiety | Psychiatric disorders | MedDRA |
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| Pollakiuria | Renal and urinary disorders | MedDRA |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA |
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| Dry throat | Respiratory, thoracic and mediastinal disorders | MedDRA |
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| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA |
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| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA |
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| Urticaria | Skin and subcutaneous tissue disorders | MedDRA |
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| Urticaria localised | Skin and subcutaneous tissue disorders | MedDRA |
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| Flushing | Vascular disorders | MedDRA |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| UCB | Cares | +1844 599 | 2273 | UCBCares@ucb.com |
| ID | Term |
|---|---|
| D006255 | Rhinitis, Allergic, Seasonal |
| D012220 | Rhinitis |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| C093875 | montelukast |
| C472067 | levocetirizine |
Not provided
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Mean Difference (Final Values) |
| -0.93 |
| 2-Sided |
| 95 |
| -2.04 |
| 0.18 |
| Superiority or Other |
| ANCOVA | <0.001 | Median Difference (Final Values) | -2.19 | 2-Sided | 95 | -3.43 | -0.95 | Superiority or Other |
10 mg of Montelukast (MLKT) was administered orally on Days 1 and 2.
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5 mg of Levocetirizine (LCTZ) was administered orally on Days 1 and 2.
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10 mg of Montelukast (MLKT) was administered orally on Days 1 and 2.
|
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10 mg of Montelukast (MLKT) was administered orally on Days 1 and 2. |
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10 mg of Montelukast (MLKT) was administered orally on Days 1 and 2.
|
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10 mg of Montelukast (MLKT) was administered orally on Days 1 and 2. |
|
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10 mg of Montelukast (MLKT) was administered orally on Days 1 and 2. |
|
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| OG002 | Montelukast (MLKT) | 10 mg of Montelukast (MLKT) was administered orally on Days 1 and 2. |
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| OG002 | Montelukast (MLKT) | 10 mg of Montelukast (MLKT) was administered orally on Days 1 and 2. |
|
|
| OG002 | Montelukast (MLKT) | 10 mg of Montelukast (MLKT) was administered orally on Days 1 and 2. |
|
|
| OG002 | Montelukast (MLKT) | 10 mg of Montelukast (MLKT) was administered orally on Days 1 and 2. |
|
|
| OG002 |
| Montelukast (MLKT) |
10 mg of Montelukast (MLKT) was administered orally on Days 1 and 2. |
|
|
| Montelukast (MLKT) |
10 mg of Montelukast (MLKT) was administered orally on Days 1 and 2. |
|
|
| Montelukast (MLKT) |
10 mg of Montelukast (MLKT) was administered orally on Days 1 and 2. |
|
|
| OG002 |
| Montelukast (MLKT) |
10 mg of Montelukast (MLKT) was administered orally on Days 1 and 2. |
|
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