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

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.

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Key information

Conditions

Rhinitis, Allergic, Seasonal Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic Rhinitis, Allergic, Perennial Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Urticaria

Age range

6 month–11 year

Sex eligibility

All sexes

Study type

Observational

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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:

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)

Other names: Aerius, Clarinex, SCH 34117, descarboethoxyloratadine

Primary outcomes

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:
- 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.

Secondary outcomes

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.

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

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

Important dates

Study start: 2008
Primary completion: 2010
Study completion: 2010
First posted: Sep 29, 2008
Registry last updated: Feb 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed