Last updated 7 months ago

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).

Eurofarma Laboratorios S.A.

478Patients around the world

This study is for people with

Flu

Requirements for the patient

From 18 Years

All Gender

Medical requirements

: Common cold: presence of moderate to severe nasal congestion and moderate to severe runny nose and at least one (01) of the following moderate to severe symptoms: sneezing, headache, myalgia, sore throat, throat pain, dysphonia, cough and fever.
Duration of symptoms ≤ 48 hours at screening.
Informed consent form (ICF) signed before carrying out any study procedure.

: Presence of significant septum deviation, compatible with impaired nasal ventilatory function, at the investigator's discretion.
Presence of nasal polyposis to previous rhinoscopy.
Known hypersensitivity to any component of the experimental drug formulation.
Required antibiotic therapy for upper airway infection treatment.

StudyRESFRIN

SponsorEurofarma Laboratorios S.A.

Conditions

Flu

Requirements

From 18 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT05118672