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

NCT ID: NCT00761527

Last Updated: 2022-02-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2980 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2010-05-31

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.

Conditions

Rhinitis, Allergic, Seasonal; Rhinitis, Allergic, Perennial; Urticaria

Study Design

• Observational Model Type: ECOLOGIC_OR_COMMUNITY
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Desloratadine Syrup

Intervention Type: 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)

Interventions

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)

Intervention Type: DRUG

Other Intervention Names

Aerius, Clarinex, SCH 34117, descarboethoxyloratadine

Eligibility Criteria

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

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

P05634

Identifier Type: -

Identifier Source: org_study_id