N/A
Completed N=2,980
Observation of Side Effects and Effectiveness of Desloratadine (Aerius) Syrup in Filipino Children (Study P05634)
Rhinitis, Allergic, Seasonal · Rhinitis, Allergic, Perennial · Urticaria
Source: ClinicalTrials.gov NCT00761527 ↗
Enrolled (actual)
2,980
Serious AEs
0.0%
Results posted
Mar 2012
Primary outcomePrimary: Number of Adverse Events Reported By Category After 14 Days of Treatment — 26; 21; 4; 1 Adverse Events
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Adverse Events Reported By Category After 14 Days of Treatment |
26; 21; 4; 1; 20; 19 | — |
| PRIMARY Safety of Desloratadine Syrup Reported by Number of Participants Experiencing Adverse Events After 14 Days of Treatment |
24; 21; 2; 1; 20; 1 | — |
| PRIMARY Participant Global Tolerability Assessment |
1278; 1339; 307; 15; 8 | — |
| SECONDARY Investigator Assessment of Clinical Efficacy |
2913; 39; 0 | — |
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
Data sourced from ClinicalTrials.gov (NCT00761527). 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.