A Phase 3 interventional study of Experimental drug (paracetamol 500mg / fexofenadine 60mg / phenylephrine 20mg) and Placebo in Cold and Flu Symptom, sponsored by Eurofarma Laboratorios S.A.. Completed at 2 sites in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by Eurofarma Laboratorios S.A. · Phase 3, Interventional, and Treatment
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).
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).
219 studies on the registry are indexed under Common Cold; 23 are open to participants now.
This study's enrollment of 567 is above the median of 150 across 184 interventional studies indexed under Common Cold.
Browse Common Cold studies →Eurofarma Laboratorios S.A. is the lead sponsor of 64 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Duration of symptoms ≤ 48 hours at screening. Form (ICF) signed before carrying out any study procedure.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Group 1: paracetamol 500mg / fexofenadine 60mg / phenylephrine 20mg FDC (experimental drug).
Drug: Experimental drug (paracetamol 500mg / fexofenadine 60mg / phenylephrine 20mg)
Group 2: Placebo
Drug: Placebo
Drug page: Acetaminophen
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.
Also known as: EF175
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.
Also known as: EF175 Placebo
Relief of cold and flu symptoms
absolute variation of the overall score obtained in the symptom assessment questionnaire (Likert Scale), in which nasal congestion, runny nose, sneezing, headache, myalgia, sore throat, throat pain hoarseness, cough and fever will be assessed on a 4-point categorical scale (0 = absent, 1 = mild, 2 = moderate and 3 = severe) after administration of the first dose of the study treatment from baseline. The overall symptom score will be determined by the sum of the points assigned to the individual symptoms. The baseline overall score will vary in the interval of 6 to 30 points, ranging from 0 to 30 points in the other assessments, and the higher the score, the worse the subject's symptoms
Time frame: 26 hours
overall efficacy of the experimental drug
subject's treatment overall evaluation 3 (±1) days after the administration of the first dose of study treatment from baseline.
Time frame: 11 days
efficacy of the experimental drug on the nasal congestion symptoms
Proportion of subjects with improved nasal congestion and runny nose 3 hours (± 30 minutes), 26 (± 2) hours and 3 (± 1) days after administration of the first dose of the study treatment from baseline, being considered improvement the reduction of at least one point on the 4-point categorical Likert scale (0 = absent, 1 = mild, 2 = moderate, and 3 = severe).
Time frame: 3 hours (± 30 minutes), 26 (± 2) hours and 3 (± 1) days after administration
duration of the experimental drug treatment
Duration (in days) of study treatment
Time frame: 7 days
use of rescue medication
Amount (in number of tablets) of rescue medication used.
Time frame: 7 days
Ran from Mar 2025 to primary completion in Aug 2025, 5 months.
Of 17 phase 3 interventional studies under Common Cold, half reached primary completion within 7 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 16. This study's 5 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Acetaminophen