Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of the study is to assess the efficacy comparability of cetirizine and levocetirizine, by comparing the effects of single intake of the two drugs to placebo in reducing symptoms of seasonal allergic rhinitis (SAR) in ragweed sensitive adult subjects exposed to ragweed pollen in an Environmental Exposure Unit.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo (PBO) | Placebo Comparator | A single dose of placebo was administered orally on Day 1. |
|
| Levocetirizine (LCTZ) 2.5 mg | Experimental | A single dose of 2.5 mg of LCTZ oral drops was administered orally on Day 1. |
|
| Levocetirizine (LCTZ) 5 mg | Experimental | A single dose of 5 mg of LCTZ oral tablet was administered orally on Day 1. |
|
| Cetirizine (CTZ) 5 mg | Experimental | A single dose of 5 mg of CTZ oral drops was administered orally on Day 1. |
|
| Cetirizine (CTZ) 10 mg | Experimental | A single dose of 10 mg of CTZ oral tablet was administered orally on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo drops | Drug |
|
|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| UCB Cares | UCB (+1 844 599 2273) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kingston | Ontario | Canada |
Not provided
| Label | URL |
|---|---|
| FDA Safety Alerts and Recalls | View source |
Not provided
Not provided
Participant Flow refers to the Randomized Set.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo (PBO) | A single dose of placebo was administered orally on Day 1. |
| FG001 | Levocetirizine (LCTZ) 2.5 mg | A single dose of 2.5 mg of LCTZ oral drops was administered orally on Day 1. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo tablets matching to levocetirizine | Drug |
|
|
| Placebo tablets matching to cetirizine | Drug |
|
|
| Levocetirizine drops | Drug |
|
|
|
| Levocetirizine tablets | Drug |
|
|
|
| Cetirizine drops | Drug |
|
|
| Cetirizine tablets | Drug |
|
|
| Baseline, Treatment Period II [Day 2, (8:30 am to 12:00 pm)] |
| Change From Baseline in the MSC Score Over the Total Treatment Period (Period I + 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. | 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 I [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, (8:30 am to 12:00 pm)] |
| Change From Baseline in the Total Symptom Complex (TSC) Score Over the Total Treatment Period (Period I + 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 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, Watery Eyes Score, Sneezes Score, Nose Blows 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. 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, Watery Eyes Score, Sneezes Score, Nose Blows 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. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline. | Baseline, Treatment Period II [Day 2, (8:30 am to 12:00 pm)] |
| Change From Baseline in the Individual Symptom Scores Over the Total Treatment Period (Period I + Period II) | Individual symptom scores include Runny Nose Score, Itchy Nose Score, Sniffles Score, Watery Eyes Score, Sneezes Score, Nose Blows 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. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline. | Baseline to Day 2 |
| FG002 | Levocetirizine (LCTZ) 5 mg | A single dose of 5 mg of LCTZ oral tablet was administered orally on Day 1. |
| FG003 | Cetirizine (CTZ) 5 mg | A single dose of 5 mg of CTZ oral drops was administered orally on Day 1. |
| FG004 | Cetirizine (CTZ) 10 mg | A single dose of 10 mg of CTZ oral tablet was administered orally on Day 1. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Baseline Characteristics refer to the Intention-to-Treat (ITT) Set.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo (PBO) | A single dose of placebo was administered orally on Day 1. |
| BG001 | Levocetirizine (LCTZ) 2.5 mg | A single dose of 2.5 mg of LCTZ oral drops was administered orally on Day 1. |
| BG002 | Levocetirizine (LCTZ) 5 mg | A single dose of 5 mg of LCTZ oral tablet was administered orally on Day 1. |
| BG003 | Cetirizine (CTZ) 5 mg | A single dose of 5 mg of CTZ oral drops was administered orally on Day 1. |
| BG004 | Cetirizine (CTZ) 10 mg | A single dose of 10 mg of CTZ oral tablet was administered orally on Day 1. |
| BG005 | Total Title |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 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. | Only patients with valid MSC 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)] |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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, (8:30 am to 12:00 pm)] |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the MSC Score Over the Total Treatment Period (Period I + 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 I and II were included in the analysis. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline to Day 2 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 I [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)] |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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, (8:30 am to 12:00 pm)] |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Total Symptom Complex (TSC) Score Over the Total Treatment Period (Period I + 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 I and II were included in the analysis. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline to Day 2 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Individual Symptom Scores Over Period I | Individual symptom scores include Runny Nose Score, Itchy Nose Score, Sniffles Score, Watery Eyes Score, Sneezes Score, Nose Blows 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. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline. | Only subjects 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)] |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Individual Symptom Scores Over Period II | Individual symptom scores include Runny Nose Score, Itchy Nose Score, Sniffles Score, Watery Eyes Score, Sneezes Score, Nose Blows 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. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline. | Only subjects 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, (8:30 am to 12:00 pm)] |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Individual Symptom Scores Over the Total Treatment Period (Period I + Period II) | Individual symptom scores include Runny Nose Score, Itchy Nose Score, Sniffles Score, Watery Eyes Score, Sneezes Score, Nose Blows 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. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline. | Only subjects with valid individual symptom scores in Period I and II were included in the analysis. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline to Day 2 |
|
Adverse events were collected from Day 1 until up to 9 days after the study drug intake.
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) | A single dose of placebo was administered orally on Day 1. | 0 | 78 | 0 | 78 | 5 | 78 |
| EG001 | Levocetirizine (LCTZ) 2.5 mg | A single dose of 2.5 mg of LCTZ oral drops was administered orally on Day 1. | 0 | 116 | 0 | 116 | 10 | 116 |
| EG002 | Levocetirizine (LCTZ) 5 mg | A single dose of 5 mg of LCTZ oral tablet was administered orally on Day 1. | 0 | 119 | 0 | 119 | 9 | 119 |
| EG003 | Cetirizine (CTZ) 5 mg | A single dose of 5 mg of CTZ oral drops was administered orally on Day 1. | 0 | 119 | 0 | 119 | 13 | 119 |
| EG004 | Cetirizine (CTZ) 10 mg | A single dose of 10 mg of CTZ oral tablet was administered orally on Day 1. | 0 | 119 | 0 | 119 | 7 | 119 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Ocular hyperaemia | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Defaecation urgency | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Syncope vasovagal | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Nervousness | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Dry throat | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Nasal dryness | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Nasal mucosal disorder | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Throat tightness | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Periorbital oedema | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Swelling face | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| UCB | UCB S.A. | +1844 599 | 2273 | UCBCares@ucb.com |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C472067 | levocetirizine |
| D017332 | Cetirizine |
| ID | Term |
|---|---|
| D006919 | Hydroxyzine |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Mean Difference (Final Values) |
| -3.25 |
| Standard Error of the Mean |
| 0.637 |
| 2-Sided |
| 95 |
| -4.50 |
| -2.00 |
| Superiority or Other |
| ANCOVA | <0.001 | Mean Difference (Final Values) | -4.13 | Standard Error of the Mean | 0.637 | 2-Sided | 95 | -5.38 | -2.88 | Superiority or Other |
| ANCOVA | <0.001 | Mean Difference (Final Values) | -3.74 | Standard Error of the Mean | 0.637 | 2-Sided | 95 | -4.99 | -2.49 | Superiority or Other |
A single dose of 5 mg of LCTZ oral tablet was administered orally on Day 1.
| OG003 | Cetirizine (CTZ) 5 mg | A single dose of 5 mg of CTZ oral drops was administered orally on Day 1. |
| OG004 | Cetirizine (CTZ) 10 mg | A single dose of 10 mg of CTZ oral tablet was administered orally on Day 1. |
|
|
A single dose of 5 mg of LCTZ oral tablet was administered orally on Day 1.
| OG003 | Cetirizine (CTZ) 5 mg | A single dose of 5 mg of CTZ oral drops was administered orally on Day 1. |
| OG004 | Cetirizine (CTZ) 10 mg | A single dose of 10 mg of CTZ oral tablet was administered orally on Day 1. |
|
|
A single dose of 5 mg of LCTZ oral tablet was administered orally on Day 1. |
| OG003 | Cetirizine (CTZ) 5 mg | A single dose of 5 mg of CTZ oral drops was administered orally on Day 1. |
| OG004 | Cetirizine (CTZ) 10 mg | A single dose of 10 mg of CTZ oral tablet was administered orally on Day 1. |
|
|
A single dose of 5 mg of LCTZ oral tablet was administered orally on Day 1. |
| OG003 | Cetirizine (CTZ) 5 mg | A single dose of 5 mg of CTZ oral drops was administered orally on Day 1. |
| OG004 | Cetirizine (CTZ) 10 mg | A single dose of 10 mg of CTZ oral tablet was administered orally on Day 1. |
|
|
A single dose of 5 mg of LCTZ oral tablet was administered orally on Day 1. |
| OG003 | Cetirizine (CTZ) 5 mg | A single dose of 5 mg of CTZ oral drops was administered orally on Day 1. |
| OG004 | Cetirizine (CTZ) 10 mg | A single dose of 10 mg of CTZ oral tablet was administered orally on Day 1. |
|
|
| OG003 | Cetirizine (CTZ) 5 mg | A single dose of 5 mg of CTZ oral drops was administered orally on Day 1. |
| OG004 | Cetirizine (CTZ) 10 mg | A single dose of 10 mg of CTZ oral tablet was administered orally on Day 1. |
|
|
| OG003 | Cetirizine (CTZ) 5 mg | A single dose of 5 mg of CTZ oral drops was administered orally on Day 1. |
| OG004 | Cetirizine (CTZ) 10 mg | A single dose of 10 mg of CTZ oral tablet was administered orally on Day 1. |
|
|
| OG003 | Cetirizine (CTZ) 5 mg | A single dose of 5 mg of CTZ oral drops was administered orally on Day 1. |
| OG004 | Cetirizine (CTZ) 10 mg | A single dose of 10 mg of CTZ oral tablet was administered orally on Day 1. |
|
|