drugset
drugset / Trial / NCT01393548

Efficacy and Safety of Combination of Brompheniramine and Phenylephrine for the Symptoms Relief of Rhinitis

NCT01393548 ↗

Phase 3 Completed 879 enrolled Ache Laboratorios Farmaceuticos S.A.
RandomizedParallel-groupOpen-labelTreatment

Summary

This is a multicenter clinical trial, phase III, non-inferiority, controlled by active medicine, open, randomized, enroll 538 children, 2 to 12 years old, with acute inflammation upper airway, characterized by nasal congestion and runny nose, lasting at least 24 hours and a maximum of 48 hours prior to inclusion. The subjects will be allocated in 2 parallel groups, and will receive the medicines of study, according of the randomization.

Timeline

Start
2014-08
Primary completion
2016-11
Completion
2016-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Phenylephrine Small molecule 1 mg/ml Oral
Subject Phenylephrine Small molecule 2.5 mg/ml Oral
Comparator Pseudoephedrine Small molecule 3 mg/ml Oral
Background Brompheniramine Small molecule 0.2 mg/ml Oral
Background Brompheniramine Small molecule 0.4 mg/ml Oral
Background Brompheniramine Small molecule 2 mg/ml Oral

Indications

rhinitis