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Phase 3 Clinical Trial to Evaluate Paracetamol /Fexofenadine /Phenylephrine in Flu and Cold Treatment
Sponsor: Eurofarma Laboratorios S.A.
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).
Official title: A Multicenter, Randomized, Parallel-group, Double-blind, Comparative Trial of the Superiority of Paracetamol 500mg/Fexofenadine 60mg/Phenylephrine 20mg Fixed-dose Combination Versus Placebo in the Symptomatic Treatment of Flu and Cold
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
567
Start Date
2025-03-26
Completion Date
2025-08-26
Last Updated
2026-09-22
Healthy Volunteers
No
Conditions
Interventions
Experimental drug (paracetamol 500mg / fexofenadine 60mg / phenylephrine 20mg)
Subjects randomized to this group will receive one (01) experimental drug film-coated tablet every eight (08) hours for three (03) days (nine \[09\] dosage administration). Subjects will be instructed to, thereafter, maintain treatment at the same dosage (one \[01\] film-coated tablet every eight \[08\] hours) in case of persistence of symptoms, discontinuing treatment when they present with no symptoms.
Placebo
Subjects randomized to this group will receive one (01) experimental drug film-coated tablet every eight (08) hours for three (03) days (nine \[09\] dosage administration). Subjects will be instructed to, thereafter, maintain treatment at the same dosage (one \[01\] film-coated tablet every eight \[08\] hours) in case of persistence of symptoms, discontinuing treatment when they present with no symptoms.
Locations (2)
Eurofarma Laboratórios S.A
São Paulo, São Paulo, Brazil
Clinica de Alergia Martti Antila
Sorocaba, São Paulo, Brazil