Rhinitis Clinical Trial
Official title:
Multicenter Clinical Trial, Phase III, Randomized, Double-blind, Placebo Controlled, Comparative for Evaluate the Efficacy and Safety of Fixed Dose Combination of Brompheniramine Maleate + Phenylephrine Chlorhydrate for the Treatment of Nasal Congestion and Runny Nose Present in Acute Crisis of Viral Rhinitis (Common Cold) and Allergic Reactions, in Patients Over 12 Years Old
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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