Observation of Side Effects and Effectiveness of Desloratadine (Aerius) Syrup in Filipino Children (Study P05634)

Study Overview
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Brief Summary
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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.

Detailed Description
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Physicians who commonly prescribed desloratadine treatment as standard care of treatment were selected enroll participants.

Official Title
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Post-marketing Surveillance of the Safety, Tolerability and Efficacy of Desloratadine Syrup Among Filipino Pediatric Patients

Conditions
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Rhinitis, Allergic, Seasonal, Rhinitis, Allergic, Perennial, Urticaria

Intervention / Treatment
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* Drug: Desloratadine Syrup


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Outpatient pediatric participants, male or female, aged 6 months to 11 years Diagnosis of allergic rhinitis or chronic idiopathic urticaria Exclusion Criteria: Known hypersensitivity to desloratadine

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants with allergic rhinitis or idiopathic urticaria<br>Outpatient pediatric participants (ages 6 months-11 years) in the Philippines with a diagnosis of allergic rhinitis or chronic idiopathic urticaria. | Drug: Desloratadine Syrup<br>* 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: Children 6 through 11 years of age, 5 mL (milliliters) of Aerius Syrup (2.5 mg [milligrams] of desloratadine) Children 1 through 5 years of age, 2.5 mL of Aerius Syrup (1.25 mg of desloratadine) Children 6 months to 11 months of age, 2 mL of Aerius Syrup (1 mg of desloratadine)<br>* Other names: Aerius, Clarinex, SCH 34117, descarboethoxyloratadine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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: Excellent Very Good Good Fair poor 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |