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Clinical Trial Summary

A Phase 3, multicenter, Randomized, Double-blind, comparative clinical trial to evaluate the association of paracetamol 500mg + Fexofenadine 60mg + Phenylephrine 20mg in the flu and common cold treatment. ⚠️Study will only be conducted in research centers in Brazil (please do not send e-mail if your center is outside brazil).


Clinical Trial Description

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). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05118672
Study type Interventional
Source Eurofarma Laboratorios S.A.
Contact Gleyce Lima, Analyst
Phone 55 11 5090-8411
Email gleyce.lima@eurofarma.com
Status Not yet recruiting
Phase Phase 3
Start date November 30, 2024
Completion date December 30, 2025

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