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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

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 Design

Related Conditions & MeSH terms

NCT number NCT05118672
Study type Interventional
Source Eurofarma Laboratorios S.A.
Contact Daniele Ms Hamamoto, Biologist
Phone +55 11 5090-8417
Email [email protected]
Status Not yet recruiting
Phase Phase 3
Start date August 17, 2022
Completion date March 30, 2025

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