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The objective of this non-interventional study is to evaluate the safety of Aerius syrup in pediatric patients aged 1-5 years old with allergic rhinitis or chronic idiopathic uticaria. The patients will receive 2.5 ml (1.25 mg) once daily.
Pediatric patients aged 1-5 years
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pediatric Patients | Those with allergic rhinitis or chronic idiopathic urticaria. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Desloratadine | Drug | 2.5 ml (1.25 mg) once daily |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients With Adverse Events | An adverse event is any untoward medical occurrence or unfavorable and unintended sign in a subject administered a pharmaceutical product, whether or not considered related to the use of that product. This includes the onset of new illness and the exacerbation of pre-existing conditions. | Follow-up visit at 3 - 5 weeks after treatment initiation |
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Inclusion Criteria:
Exclusion Criteria:
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Pediatric clinics around Hungary.
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| ID | Title | Description |
|---|---|---|
| FG000 | Aerius® Syrup | Aerius® (SCH 34117, desloratadine, DL) syrup administered to those with allergic rhinitis or chronic idiopathic urticaria |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Aerius® Syrup | Aerius® (SCH 34117, desloratadine, DL) syrup administered to those with allergic rhinitis or chronic idiopathic urticaria |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion of Patients With Adverse Events | An adverse event is any untoward medical occurrence or unfavorable and unintended sign in a subject administered a pharmaceutical product, whether or not considered related to the use of that product. This includes the onset of new illness and the exacerbation of pre-existing conditions. | Posted | Number | participants | Follow-up visit at 3 - 5 weeks after treatment initiation |
|
|
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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 | Aerius® Syrup | Aerius® (SCH 34117, desloratadine, DL) syrup administered to those with allergic rhinitis or chronic idiopathic urticaria |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck, Sharp & Dohme Corp. | ClinicalTrialsDisclosure@merck.com |
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| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D014581 | Urticaria |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C121345 | desloratadine |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| 1 |
| 100 |
| 6 |
| 100 |
| Pyrexia | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA (11.0) | Systematic Assessment |
|
Any trial related information may be released by the PI to third party only after written consent is obtained from the sponsor. This restriction is valid until 5 years after study closure.
| D010038 |
| Otorhinolaryngologic Diseases |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |