NCT00761527

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2,980 (actual)
• Sponsor: Organon and Co · Industry
• Sex: All
• Age: 6 Months – 11 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rhinitis, Allergic, Seasonal
• Rhinitis, Allergic, Perennial
• Urticaria

Interventions

Type	Name	Description
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: * 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)

Timeline

• Start date: 2008-03-01
• Primary completion: 2010-05-01
• Completion: 2010-05-01
• First posted: 2008-09-29
• Last updated: 2022-02-09
• Results posted: 2012-03-01