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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
167
Improvement of nasal congestion and runny nose, after 48 hours of treatment
Improvement is defined as a reduction of at least one point on the rating scale, in both nasal symptoms, after 48 hours of treatment. Participants were evaluated (self-assessment) for pain intensity by using a 4-point rating scale: 0=none, 1=mild, 2=moderate, and 3=severe.
Time frame: 48 hours after single dose of double-blind treatment
Overall score of nasal and extranasal symptoms (nasal congestion, runny nose, sneezing, watery eyes and itching)
Time frame: After 2 and 5 (± 1) days of treatment.
Clinical score of upper airway compromise
Time frame: After 2 and 5 (± 1) days of treatment
Proportion of subjects who used at least once the rescue medication
Time frame: Within 2 days and the period of 5 (± 1) days of treatment
Safety descriptive about occurence of adverse events, evaluation of results of general physical examination.
Collection of safety data throughout the whole study period
Time frame: Will be evaluated during the 5(± 1) days of treatment
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