drugset / Trial / NCT05214911

Fixed Dose Combination of Desloratadine / Prednisolone in the Treatment of Moderate Severe Allergic Rhinitis in Children

NCT05214911

Phase 3 Completed 262 enrolled Eurofarma Laboratorios S.A.
RandomizedParallel-groupDouble-blindTreatment

Summary

Multicenter, randomized, parallel-group, double-blind, double-dummy, comparative clinical trial of the superiority of the fixed-dose combination of desloratadine 0.5 mg/mL and prednisolone 4 mg/mL from Eurofarma Laboratórios SA versus desloratadine 0.5 mg/mL in the treatment of moderate to severe persistent allergic rhinitis in children aged 6 to 12 years. ⚠️Study will only be conducted in research centers in Brazil (please do not send e-mail if your center is outside brazil).

Timeline

Start
2024-07-08
Primary completion
2025-03-23
Completion
2025-03-23

Drugs

EvaluationDrugModalityDoseRoute
Comparator Desloratadine Small molecule 0.5 mg/ml Oral
Subject Prednisolone Other / unclassified 4 mg/ml Oral

Indications