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

NCT00761527 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2980

Last updated 2022-02-09

Study results available
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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.

Conditions

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

Interventions

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)

Sponsors & Collaborators

  • Organon and Co

    lead INDUSTRY

Eligibility

Min Age
6 Months
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2010-05-31
Completion
2010-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00761527 on ClinicalTrials.gov