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

Completed

• Conditions: Rhinitis, Allergic, Seasonal; Rhinitis, Allergic, Perennial; Urticaria
• Interventions: Drug: Desloratadine Syrup

• Registration Number: NCT00761527
• Lead Sponsor: Organon and Co

Brief Summary

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

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

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-09-25
• Study First Submitted QC: 2008-09-26
• Study First Posted: 2008-09-29
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Results First Submitted: 2011-11-04
• Results First Submitted QC: 2012-01-27
• Results First Posted: 2012-03-01
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-07
• Last Update Posted: 2022-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2980

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants with allergic rhinitis or idiopathic urticaria	Desloratadine Syrup	Outpatient pediatric participants (ages 6 months-11 years) in the Philippines with a diagnosis of allergic rhinitis or chronic idiopathic urticaria.

Primary Outcome Measures

Name	Time	Method
Safety of Desloratadine Syrup Reported by Number of Participants Experiencing Adverse Events After 14 Days of Treatment	15 Days	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.
Participant Global Tolerability Assessment	Day 15	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.
Number of Adverse Events Reported By Category After 14 Days of Treatment	15 Days	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.

Secondary Outcome Measures

Name	Time	Method
Investigator Assessment of Clinical Efficacy	Day 15	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.