Multicenter Clinical Trial, Phase III, Randomized, Open, Parallel Group, Comparative for Evaluate the Efficacy and Safety of Fixed Dose Combinations of Brompheniramine Maleate + Phenylephrine Chlorhydrate in Different Dosage Forms Versus Fixed Dose Combination of Reference for the Treatment of Nasal Congestion and Runny Nose Present in Acute Crisis of Viral Rhinitis (Common Cold) and Allergic Reactions, in Patients From 2 to 12 Years Old

Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2014
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.
Epistemonikos ID: e1d447c8bf92935c66031cac323dece18430f579
First added on: Mar 23, 2020