Phase 3 Clinical Trial to Evaluate Paracetamol /Fexofenadine /Phenylephrine in Flu and Cold Treatment (RESFRIN)

October 9, 2023 updated by: Eurofarma Laboratorios S.A.

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

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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 will only be conducted in research centers in Brazil (please do not send e-mail if your center is outside brazil).

Study Type

Interventional

Enrollment (Estimated)

478

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
      • São Paulo, Brazil, 06696-000
    • SP
      • Sorocaba, SP, Brazil
        • Clinica de Alergia Martti Antila

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental drug (paracetamol 500mg / fexofenadine 60mg / phenylephrine 20mg)
Group 1: paracetamol 500mg / fexofenadine 60mg / phenylephrine 20mg FDC (experimental drug).
Drug: 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.
Other Names:
  • EF175
Placebo Comparator: Placebo group
Group 2: Placebo
Drug: 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.
Other Names:
  • EF175 Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
26 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
11 days
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 hours (± 30 minutes), 26 (± 2) hours and 3 (± 1) days after administration
duration of the experimental drug treatment
Time Frame: 7 days
Duration (in days) of study treatment
7 days
use of rescue medication
Time Frame: 7 days
Amount (in number of tablets) of rescue medication used.
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eurofarma Laboratorios S.A.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 30, 2024

Primary Completion (Estimated)

July 30, 2025

Study Completion (Estimated)

March 30, 2026

Study Registration Dates

First Submitted

October 5, 2021

First Submitted That Met QC Criteria

November 3, 2021

First Posted (Actual)

November 12, 2021

Study Record Updates

Last Update Posted (Estimated)

October 10, 2023

Last Update Submitted That Met QC Criteria

October 9, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EF175

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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