Trials / Not Yet Recruiting

Not Yet RecruitingNCT06272409

Efficacy and Safety of DEP114 in the Treatment of Moderate to Severe Persistent Allergic Rhinitis in Children.

Phase III, Multicenter, Double-blind, Planned, Parallel Clinical Trial to Evaluate the Efficacy and Safety of DEP114 in the Treatment of Moderate to Severe Persistent Allergic Rhinitis in Children Aged Between 6 and 11 Years

Status: Not Yet Recruiting
Phase: Phase 3
Study type: Interventional
Enrollment: 318 (estimated)

Sponsor: EMS · Industry
Sex: All
Age: 6 Years – 11 Years
Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of DEP114 in the treatment of Moderate to Severe Persistent Allergic Rhinitis in children aged between 6 and 11 years.

Detailed description

* double-blind, superiority, parallel group trial. * Experiment duration: 05 days. * 03 visits (days 0, 5 and 28). * Efficacy will be evaluated for persistent allergic rhinitis based on Global improvement in nasal symptoms score * Adverse events evaluation.

Conditions

Allergic Rhinitis

Interventions

Type	Name	Description
DRUG	DEP114	DEP114 oral solution
DRUG	Desloratadine 0.5 MG/ML	Desloratadine oral solution

Timeline

Start date: 2025-02-15
Primary completion: 2025-03-15
Completion: 2027-04-15
First posted: 2024-02-22
Last updated: 2024-02-22

Source: ClinicalTrials.gov record NCT06272409. Inclusion in this directory is not an endorsement.