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

NCT05214911 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 262

Last updated 2025-04-17

No results posted yet for this study

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).

Conditions

  • Allergic Rhinitis

Interventions

DRUG

Desloratadine , Prednisolone

FDC desloratadine 0.5 mg/mL/prednisolone 4 mg/mL from Eurofarma Laboratórios SA

DRUG

Desloratadine

Desloratadine 0.5 mg/mL (Desalex® - Eurofarma Laboratórios SA)

Sponsors & Collaborators

  • Eurofarma Laboratorios S.A.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Brazil

Study Locations

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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 NCT05214911 on ClinicalTrials.gov