N/A 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

Bottom Line

View on ClinicalTrials.gov: NCT00761527 ↗

Enrolled (actual)

2,980

Serious AEs

0.0%

Results posted

Mar 2012

Primary outcome: Primary: Number of Adverse Events Reported By Category After 14 Days of Treatment — 26; 21; 4; 1 Adverse Events

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: Desloratadine Syrup (Drug)
Age: Pediatric · 0+ yrs
Sex: All
Sponsor: Organon and Co
Primary completion: May 2010

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	—

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.

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

View full record on ClinicalTrials.gov →

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.