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NCT Number: NCT05118672

Phase 3 Clinical Trial to Evaluate Paracetamol /Fexofenadine /Phenylephrine in Flu and Cold 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).

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Key information

Conditions

Cold Common Cold Flu Symptom Infections Picornaviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Clinica de Alergia Martti Antila, Sorocaba, São Paulo, Brazil

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Experimental drug (paracetamol 500mg / fexofenadine 60mg / phenylephrine 20mg)

Drug

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.

Other names: EF175

Placebo

Drug

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.

Other names: EF175 Placebo

Primary outcomes

  1. Relief of cold and flu symptoms

    Time frame: 26 hours

    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

Secondary outcomes

  1. overall efficacy of the experimental drug

    Time frame: 11 days

    subject's treatment overall evaluation 3 (±1) days after the administration of the first dose of study treatment from baseline.

  2. efficacy of the experimental drug on the nasal congestion symptoms

    Time frame: 3 hours (± 30 minutes), 26 (± 2) hours and 3 (± 1) days after administration

    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).

  3. duration of the experimental drug treatment

    Time frame: 7 days

    Duration (in days) of study treatment

  4. use of rescue medication

    Time frame: 7 days

    Amount (in number of tablets) of rescue medication used.

Sponsors and collaborators

Lead sponsor

Eurofarma Laboratorios S.A.

Industry

Registry information

Official study 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

Acronym: RESFRIN

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Nov 12, 2021
Registry last updated
Sep 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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