Observation of Side Effects and Effectiveness of Desloratadine (Aerius) Syrup in Filipino Children (Study P05634)
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|ClinicalTrials.gov Identifier: NCT00761527|
Recruitment Status : Completed
First Posted : September 29, 2008
Results First Posted : March 1, 2012
Last Update Posted : July 28, 2015
|Condition or disease||Intervention/treatment|
|Rhinitis, Allergic, Seasonal Rhinitis, Allergic, Perennial Urticaria||Drug: Desloratadine Syrup|
|Study Type :||Observational|
|Actual Enrollment :||2980 participants|
|Observational Model:||Ecologic or Community|
|Official Title:||Post-marketing Surveillance of the Safety, Tolerability and Efficacy of Desloratadine Syrup Among Filipino Pediatric Patients|
|Study Start Date :||March 2008|
|Actual Primary Completion Date :||May 2010|
|Actual Study Completion Date :||May 2010|
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.
Drug: Desloratadine Syrup
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:
Other Name: Aerius, Clarinex, SCH 34117, descarboethoxyloratadine
- Number of Adverse Events Reported By Category After 14 Days of Treatment [ Time Frame: 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.
- Safety of Desloratadine Syrup Reported by Number of Participants Experiencing Adverse Events After 14 Days of Treatment [ Time Frame: 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 [ Time Frame: Day 15 ]
The participant's global assessment of tolerability with the medication was assessed using a categorical scale as follows:
- Very Good
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.
- Investigator Assessment of Clinical Efficacy [ Time Frame: 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.