drugset / Trial / NCT01393561

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

NCT01393561

Phase 3 Completed 167 enrolled Ache Laboratorios Farmaceuticos S.A.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a multicenter clinical trial, phase III, superiority, controlled by active medicine, double-blind, randomized, enroll 166 children, over 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
2014-07
Primary completion
2014-10
Completion
2014-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Brompheniramine Small molecule
Subject Phenylephrine Small molecule

Indications