Phase 3 Clinical Trial to Evaluate Paracetamol /Fexofenadine /Phenylephrine in Flu and Cold Treatment
478 patients around the world
Available in Brazil
A multicenter, randomized, double-blind, parallel-group, superiority, placebo control
clinical trial.
Adult patients (aged ≥ 18 years) of both sexes with common cold or flu will be randomized in
a 1:1 ratio to receive the experimental drug (paracetamol 500mg / fexofenadine 60mg /
phenylephrine 20mg) or placebo, in the dosage of one (01) film-coated tablet every eight (08)
hours, for 3 to 7 days.
The primary superiority assessment will be carry out compared the experimental drug to
placebo in the relief of cold and flu symptoms through the absolute variation of the overall
score obtained in the symptom assessment questionnaire after treatment start.
⚠️Study will only be conducted in research centers in Brazil (please do not send e-mail if
your center is outside brazil).