N/A
Completed N=591
Response of Desloratadine Syrup in the Relief of Symptoms Associated With Perennial Allergic Rhinitis in Pediatric Patients (Study P04299)
Source: ClinicalTrials.gov NCT00704769 ↗Enrolled (actual)
591
Serious AEs
0.0%
Results posted
Aug 2009
Primary outcomePrimary: Adverse Events — 3; 1 Participants
Summary
Evaluate the safety and general clinical response of desloratadine syrup in the relief of symptoms associated with perennial allergic rhinitis in Indonesian pediatric patients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adverse Events |
3; 1 | — |
| PRIMARY General Clinical Response of Desloratadine Syrup Based on the Physician's Judgments |
350; 159; 50; 11 | — |
Eligibility Criteria
Inclusion Criteria
- Children patients of both sexes aged between 2-11 years, of either gender and any race
- Unequivocal history of perennial allergic rhinitis, including nasal congestion, sneezing, rhinorrhea, pruritus, and lacrimation
- Minimum score for inclusion: 10
- Capable of complying with the dosing regimen
- Free of any clinically significant disease (other than allergic rhinitis)
- Antihistamine must be justified by investigating doctor
Exclusion Criteria
- Patients with asthma who require chronic use of inhaled or systemic corticosteroids
- History of frequent, clinically significant sinusitis or chronic purulent postnasal drip
- Patients with rhinitis medicamentosa
- History of hypersensitivity to desloratadine or any of its excipients
- Doctor deems unsuitable
Data sourced from ClinicalTrials.gov (NCT00704769). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.