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

NCT05118672 | Completed Phase 3

• 1 other identifier: EF175
• Study Type: interventional
• Target: 567
• Locations: 1 country
• Sites: 2

Brief 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).

Conditions

Cold; Flu Symptom

Outcome Measures

Primary Outcomes (1)

• 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

  26 hours

Secondary Outcomes (4)

• overall efficacy of the experimental drug

  11 days

• efficacy of the experimental drug on the nasal congestion symptoms

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

• duration of the experimental drug treatment

  7 days

• use of rescue medication

  7 days

Study Arms (2)

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

EXPERIMENTAL

Group 1: paracetamol 500mg / fexofenadine 60mg / phenylephrine 20mg FDC (experimental drug).

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

Placebo group

PLACEBO COMPARATOR

Group 2: Placebo

Drug: Placebo

Interventions

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.

Also known as: EF175

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

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.

Also known as: EF175 Placebo

Placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Eurofarma Laboratorios S.A.: lead

Study Sites (2)

Eurofarma Laboratórios S.A

São Paulo, São Paulo, 06696-000, Brazil

Location

Clinica de Alergia Martti Antila

Sorocaba, São Paulo, Brazil

Location

MeSH Terms

Conditions

Common Cold

Interventions

Drugs, Investigational; Acetaminophen; fexofenadine; Phenylephrine

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Group 1: Eurofarma Laboratórios SA paracetamol 500mg / fexofenadine 60mg / phenylephrine 20mg FDC (experimental drug). Group 2: Placebo.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Adult participants (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 500 mg / fexofenadine 60 mg / phenylephrine 20 mg) or placebo, in the dosage of one (01) film-coated tablet every eight (08) hours, for 3 to 7 days. Randomized participants will be instructed to use the study treatment uninterruptedly, every eight (08) hours, for three (03) days, and may, after that, discontinue treatment at any time if they experience no more symptoms.

Study Record Dates

• First Submitted: October 5, 2021
• First Posted: November 12, 2021
• Study Start: March 26, 2025
• Primary Completion: August 26, 2025
• Study Completion: August 26, 2025
• Last Updated: September 22, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)