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The purpose of this study is to observe the side effects of desloratadine syrup and how effective it is in relieving symptoms of allergic rhinitis or hives in Filipino children. The participants will take desloratadine syrup for 14 days. At the end of treatment, side effects will be recorded, as well as how the participants tolerate the medication. Effectiveness will also be rated at the end of treatment.
Physicians who commonly prescribed desloratadine treatment as standard care of treatment were selected enroll participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with allergic rhinitis or idiopathic urticaria | Outpatient pediatric participants (ages 6 months-11 years) in the Philippines with a diagnosis of allergic rhinitis or chronic idiopathic urticaria. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Desloratadine Syrup | Drug | Desloratadine (Aerius) Syrup; Dose selection was based upon the age of the participant, and the timing of dose for each participant was once daily (QD) as described in the Product Insert for 14 days:
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Adverse Events Reported By Category After 14 Days of Treatment | Safety was assessed by determining the incidence of all Adverse Events (AE) which occurred between Baseline Visit (Day 1) & Final Visit (Day 15) & were recorded in Case Report Forms. Total number of AEs reported were presented in several categories. Classification, causality & intensity for AEs were determined by investigator after obtaining sufficient information. A Serious Adverse Event (SAE) was any adverse drug experience that resulted in: death; life-threatening condition; inpatient hospitalization/prolongation of existing hospitalization; persistent or significant disability/incapacity. | 15 Days |
| Safety of Desloratadine Syrup Reported by Number of Participants Experiencing Adverse Events After 14 Days of Treatment | Safety was assessed by determining the incidence of all AEs which occurred between Baseline Visit (Day 1) & Final Visit (Day 15) & were recorded in Case Report Forms. Number of participants experiencing AEs were presented in several categories. Some AEs lead to discontinuation (d/c). Classification, causality & intensity for AEs were determined by investigator. A SAE was any adverse drug experience that resulted in any of the following: death; life-threatening condition; inpatient hospitalization/prolongation of existing hospitalization; persistent or significant disability/incapacity. | 15 Days |
| Participant Global Tolerability Assessment | The participant's global assessment of tolerability with the medication was assessed using a categorical scale as follows:
Parent or guardian of each participant followed up for a final visit after 14 days (Day 15) at which tolerability was rated and reported for entire treatment period. Number of participants in each category is presented. | Day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Investigator Assessment of Clinical Efficacy | Investigator assessment of clinical efficacy of Desloratadine Syrup in relieving participants' symptoms of either allergic rhinitis or chronic idiopathic urticaria at final visit (Day 15). The number of participants categorized by investigator as: improved, no improvement, or worsened was reported at Day 15. | Day 15 |
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Inclusion Criteria:
Exclusion Criteria:
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A total of 3000 prospective outpatient pediatric participants with either allergic rhinitis or chronic idiopathic urticaria will be enrolled in the study coming from about 300 sites in the Phillipines
The total number of participants enrolled was 2980. A total of 2978 participants received at least one dose of study medication.
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| ID | Title | Description |
|---|---|---|
| FG000 | Desloratadine (Aerius) Syrup | Pediatric participants with a diagnosis of allergic rhinitis or chronic idiopathic urticaria received Desloratadine (Aerius) Syrup. Dose selection was based upon the age of the participant, and the timing of dose for each participant was once daily (QD) as described in the Product Insert for 14 days:
|
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Desloratadine (Aerius) Syrup | Pediatric participants with a diagnosis of allergic rhinitis or chronic idiopathic urticaria received Desloratadine (Aerius) Syrup. Dose selection was based upon the age of the participant, and the timing of dose for each participant was once daily (QD) as described in the Product Insert for 14 days:
|
| 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 | Number of Adverse Events Reported By Category After 14 Days of Treatment | Safety was assessed by determining the incidence of all Adverse Events (AE) which occurred between Baseline Visit (Day 1) & Final Visit (Day 15) & were recorded in Case Report Forms. Total number of AEs reported were presented in several categories. Classification, causality & intensity for AEs were determined by investigator after obtaining sufficient information. A Serious Adverse Event (SAE) was any adverse drug experience that resulted in: death; life-threatening condition; inpatient hospitalization/prolongation of existing hospitalization; persistent or significant disability/incapacity. | The Safety population included all participants who had taken at least one dose of Desloratadine Syrup. | Posted | Number | Adverse Events | 15 Days |
|
Safety Population included all participants who had taken at least one dose of Desloratadine Syrup.
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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 | Desloratadine (Aerius) Syrup | Pediatric participants with a diagnosis of allergic rhinitis or chronic idiopathic urticaria received Desloratadine (Aerius) Syrup. Dose selection was based upon the age of the participant, and the timing of dose for each participant was once daily (QD) as described in the Product Insert for 14 days:
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA 13.1 | Reported by the prescribing physician as unrelated to study drug. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D006255 | Rhinitis, Allergic, Seasonal |
| D012221 | Rhinitis, Allergic, Perennial |
| D014581 | Urticaria |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C121345 | desloratadine |
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|
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| Unknown reason |
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| years |
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| Sex/Gender, Customized | Number of participants with non-missing data for the relevant variable in the safety population (N= 2968) which included all participants who had taken at least one dose of study medication. | Number | Participants |
|
|
|
| Primary | Safety of Desloratadine Syrup Reported by Number of Participants Experiencing Adverse Events After 14 Days of Treatment | Safety was assessed by determining the incidence of all AEs which occurred between Baseline Visit (Day 1) & Final Visit (Day 15) & were recorded in Case Report Forms. Number of participants experiencing AEs were presented in several categories. Some AEs lead to discontinuation (d/c). Classification, causality & intensity for AEs were determined by investigator. A SAE was any adverse drug experience that resulted in any of the following: death; life-threatening condition; inpatient hospitalization/prolongation of existing hospitalization; persistent or significant disability/incapacity. | The Safety population included all participants who had taken at least one dose of Desloratadine Syrup. | Posted | Number | Participants | 15 Days |
|
|
|
| Secondary | Investigator Assessment of Clinical Efficacy | Investigator assessment of clinical efficacy of Desloratadine Syrup in relieving participants' symptoms of either allergic rhinitis or chronic idiopathic urticaria at final visit (Day 15). The number of participants categorized by investigator as: improved, no improvement, or worsened was reported at Day 15. | ITT Population, which consisted of all participants who had taken at least one dose of Desloratadine Syrup and had a post baseline clinical efficacy assessment (N=2956). For 4 participants, a clinical efficacy assessment was not reported. | Posted | Number | Participants | Day 15 |
|
|
|
| Primary | Participant Global Tolerability Assessment | The participant's global assessment of tolerability with the medication was assessed using a categorical scale as follows:
Parent or guardian of each participant followed up for a final visit after 14 days (Day 15) at which tolerability was rated and reported for entire treatment period. Number of participants in each category is presented. | The Safety population included all participants who had taken at least one dose of Desloratadine Syrup (N=2978). For 31 participants, tolerability was not assessed. | Posted | Number | Participants | Day 15 |
|
|
|
| 1 |
| 2,978 |
| 0 |
| 2,978 |
|
SPONSOR is the owner of all the data in the record forms including subsequent reports relating to this study. The prescribing physicians & investigators agree only to use such information to conduct the study & will not be able to publish the results of any part of this study without previous written authorization from SPONSOR. By signing the protocol, the investigator accepts that the results may be used in written publications & for the purpose of providing information to health professionals.
| D012130 |
| Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| Title | Measurements |
|---|---|
|
| Number of Participants with Severe AEs |
|
| Number of Participants with Treatment-related AEs |
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| Number of Participants with AEs - Temporary d/c |
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| Number of Participants with AEs - Permanent d/c |
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| Number of Participants with AEs - Withdrawal |
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| Number of Participants with SAEs |
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| Number of Participants with Treatment-related SAEs |
|
| Number of Participants Who Died Due to AEs |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|
|
| Fair |
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| Poor |
|